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A Phase II Study of M2951 in SLE

Primary Purpose

Systemic Lupus Erythematosus

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

M2951

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, M2951, Placebo, Dose response, Oral Corticosteroids, Safety, Efficacy, Autoimmune And Inflammatory Disorders

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eligible male and female participants, aged 18 to 75 years
Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening
SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI greater than or equal to (>=) 4) at Screening Visit
And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Participants are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension
Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg)
Acutely worsened renal function
Central nervous system SLE
Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (>) 30 mg daily prednisone equivalent
Use of injectable corticosteroids, or change in dose of corticosteroids.
Other protocol defined exclusion criteria could apply

Sites / Locations

Pinnacle Research Group LLC
Arizona Arthritis & Rheumatology Associates, P.C.
Arizona Arthritis & Rheumatology Associates, P.C.
Advanced Research Center, Inc.
Wallace Rheumatic Study Center
Medvin Clinical Research
Southern California Permanent Medical Group
Global Research Management
University of Southern California
East Bay Rheumatology Medical Group, Inc.
Inland Rheumatology Clinical Trials, Inc.
Nazanin Firooz, MD Inc.
University of Colorado Denver Anschutz Medical Campus
Yale School Of Medicine
Clinical Research of West Florida - Corporate
Omega Research Consultants
Center for Rheumatology, Immunology & Arthritis
Hope Clinical Trials
IRIS Research and Development
McIlwain Medical Group, PA
Meridien Research, Inc.
Marietta Rheumatology Associates, PC
The University of Chicago Medicine
LSU Health Sciences Center Gastroenterology
Beth Israel Deaconess Medical Center
Henry Ford Health System
AA MRC LLC Ahmed Arif Medical Research Center
University of Mississippi Medical Center
Washington University in St. Louis
Montefiore Medical Center PRIME
Hospital for Special Surgery
SUNY Upstate Medical Center
University of North Carolina at Chapel Hill
Medication Management, LLC
Allegheny-Singer Research Institute
Innovative Clinical Research, LLC
Metroplex Clinical Research Center, LLC
Accurate Clinical Research, Inc.
Accurate Clinical Management - Brionez
Medical Center Research, LLC Webster Office
DM Clinical Research
FSAEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF
Instituto de Investigaciones Clinicas
Instituto de Investigaciones Clinicas Quilmes
Centro Medico Privado de Reumatologia
Investigaciones Clinicas Tucuman
Centro Integral de Reumatologia
APRILLUS
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
Clinica Adventista Belgrano
Hospital Britanico de Buenos Aires
Hospital General de Agudos Dr. J. M. Ramos Mejia
Sanatorio Allende
Instituto de Reumatologia
Cordis S.A.
Centro Polivalente de Asistencia e Inv. Clinica CER
UMHAT "Pulmed" OOD
MHAT - Ruse, AD
Medizinski Zentar-1-Sevlievo EOOD
Medical Center "Excelsior", OOD
Medical Center Comac Medical EOOD
UMHAT "SofiaMed", OOD
UMHAT "Sv. Ivan Rilski", EAD
Corporacion de Beneficencia Osorno
Centro de Estudios Reumatologicos
Centro Medico Prosalud
Interin
Psicomedica Clinical and Research Group
Quantum Research Santiago
Centro de Reumatologia y Ortopedia SAS
Clínica de la Costa Ltda.
Fundacion Instituto de Reumatologia Fernando Chalem
Simedics Ips Sas
Servimed S.A.S.
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Humanitas Research Hospital
Ospedale San Raffaele
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
Policlinico Universitario Agostino Gemelli
Ehime University Hospital
Tobata General Hospital
University of Occupational and Environmental Health Hospital
NHO Asahikawa Medical Center
Kanazawa University Hospital
Kagawa University Hospital
Eiraku Clinic
Tohoku University Hospital
Seirei Hamamatsu General Hospital
Dokkyo Medical University Hospital
St. Luke's International Hospital
Tokyo Metropolitan Tama Medical Center
Nihon University Itabashi Hospital
Keio University Hospital
Tottori University Hospital
Seoul National University Bundang Hospital
Ajou University Hospital
Dong-A University Hospital
Kyungpook National University Hospital
Konkuk University Medical Center
Severance Hospital, Yonsei University
The Catholic University of Korea, Yeouido St. Mary's Hospital
Hospital Pakar Sultanah Fatimah
Hospital Umum Sarawak
Hospital Selayang
International Medical University (IMU) Healthcare
Hospital Kuala Lumpur
CAP Research
Unidad de Investigacion de las Enfermedades Reumaticas
Clinstile, S.A. de C.V.
Clinical Research Institute S.C.
Morales Vargas Centro de Investigacion, S.C.
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Unidad de Investigacion en Enfermedades Cronico Degenerativas SC
Accelerium S. de R.L. de C.V.
Hospital Central Dr Ignacio Morones Prieto
Investigacion y Biomedicina de Chihuahua, S.C.
Hogar Clínica San Juan de Dios - Arequipa
Clinica El Golf
Clinica Medica Cayetano Heredia
Clinica San Juan Bautista
Clinica Vesalio
GINOBS SA. Instituto de Ginecologia y Reproduccion
Hospital Nacional Cayetano Heredia
University of Washington Medical Center
ICCV Research Instituto del Cerebro y la Columna Vertebral
Angeles University Foundation Medical Center
Mary Mediatrix Medical Center
De La Salle University Medical Center
Davao Doctors Hospital
Southern Philippines Medical Center
Iloilo Doctors Hospital
St. Luke's Medical Center
CERMED
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek. Barbara Bazela
Centrum Medyczne Plejady
Nzoz Atopia
Rheuma Medicus Zaklad
Spitalul Clinic "Dr.I. Cantacuzino"
Spitalul Clinic "Sf. Maria"
S.C Mediab S.R.L
LLC "Alliance Biomedical - Ural Group"
TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich
HMA - Hospital Maria Auxiliadora
Ultramed
LLC Medical Sanitary Unit#157
SPb SBIH "Clinical Rheumatological Hospital # 25"
SIH "Saratov City Clinical Hospital # 12"
Research Institute of Emergency Medical Care
Nebbiolo LLC
Wits Clinical Research
Winelands Medical Research Centre
Naidoo, A - Netcare Umhlanga Hospital
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Taichung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Placebo Comparator

Experimental

Arm Label

Double-Blind Placebo-Controlled (DBPC) Period: Placebo

DBPC Period: M2951 25 mg QD

DBPC Period: M2951 75 mg QD

DBPC Period: M2951 50 mg BID

Long-Term Extension (LTE) Period: Placebo/ M2951 50 mg BID

LTE Period: M2951 25 mg QD/ M2951 50 mg BID

LTE Period: M2951 75 mg QD/ M2951 50 mg BID

LTE Period: M2951 50 mg BID/ M2951 50 mg BID

Arm Description

Outcomes

Primary Outcome Measures

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52

SRI-4 response was defined as greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE) divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52

SRI-6 response was defined as >= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).

DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)

Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: events between first dose of study drug that were absent before treatment/that worsened relative to pre-treatment state up to 56 weeks. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported.

DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)

Severity of TEAEs were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 1= Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with TEAEs by severity were reported.

DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, respiratory rate, weight and height. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported.

DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings

12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. The corrected QT interval (QTcF) was calculated using Fridericia's formula. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.

DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters

Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported.

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 2.

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 4.

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 12.

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 24.

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 36.

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 52

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 56

DBPC Period: Mean Absolute Total B Cell Count at Week 4

Mean total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.

DBPC Period: Mean Absolute Total B Cell Count at Week 24

Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.

DBPC Period: Mean Absolute Total B Cell Count at Week 52

Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.

DBPC Period: Mean Absolute Total B Cell Count at Week 56

Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

DBPC Period: Change From Baseline in Total B Cell Count at Week 4

Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.

DBPC Period: Change From Baseline in Total B Cell Count at Week 24

DBPC Period: Change From Baseline in Total B Cell Count at Week 52

DBPC Period: Change From Baseline in Total B Cell Count at Week 56

Secondary Outcome Measures

DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare

BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. Time to first severe flare, where a severe flare is defined as at least one BILAG A (Severe disease activity) score in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52-Week Treatment. It was measured using Kaplan-Meier (KM) estimates.

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup

SRI-4 response was defined as greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup

DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare

BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. A Moderate to Severe (BILAG A or 2B) flare is defined as at least one BILAG A (severe disease activity) grade or two BILAG B (moderate disease activity) grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment. It was measured using Kaplan-Meier (KM) estimates.

DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period

A participant has a flare-free status if no flare has been reported during the 52-week treatment period. Participants who discontinued treatment prior to Week 52, without having a flare are counted as not being flare free at Week 52. A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.

DBPC Period: Annualized Flare Rate

A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG 2004 assessment.

DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52

Low disease activity is defined as SLEDAI-2K score <=2. SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).

DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Clinical Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52

DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).

DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70).

DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52

BICLA response defined as participants meeting following criteria: [1] At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (example: all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D; [2] No new BILAG A or more than one new BILAG B scores; [3] No worsening of total SLEDAI-2K score from baseline; [4] No significant deterioration (=<10%) in physician's global assessment and [5] No treatment failure (initiation of non-protocol treatment).

DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

BILAG 2004 disease activity Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity.

DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

The Physician's Global Assessment of Disease Activity was recorded using the 100 millimeter horizontal Visual Analog Scale (VAS). Physician rated participant's disease activity on a scale ranged from 0-100 millimeter (mm), where 0 indicated no disease activity and 100 represented maximum disease activity.

DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52

The 36-Item Short-Form Health Survey (SF-36) was a standardized survey evaluating 8 aspects of functional health and well-being. These eight subscales were summarized as relating to either physical health or mental health. Physical component summary (PCS) was based primarily on physical functioning, role-physical, bodily pain, and general health scales and mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 - 100 (100 = highest level of mental functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100 = highest level of physical functioning).

DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52

The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (perfect health). A higher score indicates better health and positive changes from baseline indicate improvement of health.

DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52

The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.

DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52

The Lupus QoL assessment is a 34 item questionnaire across 8 domains that is designed to find out how systemic lupus erythematosus (SLE) affects a participant's life. Domains include physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4=never, 3=occasionally, 2= a good bit of the time, 1=most of the time, and 0=worst of the time. Summary scores can be calculated for all 8 domains. A LupusQoL score for each domain was reported on a 0 to 100 scale, with greater values indicating better health related QoL.

DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening

The PGIC is a self-rated scale that asks the participant to describe the change in activity limitations, symptoms, emotions, and overall quality of life (QoL) related to the participants painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Number of participants in the PGIC categories of any improvement (that is PGIC scale score 1, 2 or 3), no change (that is PGIC scale score 4) and any worsening (that is PGIC scale score 5, 6 or 7) are reported.

DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52

The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status.

DBPC Period: Number of Participants With Change From Baseline in Prednisone Equivalent Corticosteroid (CS) Dose by >=25% to a Dose of <=7.5 Milligram Per Day (mg/Day), With no BILAG A or 2B Flare in Disease Activity at Week 52

BILAG A or 2B flare is defined as at least one BILAG A grade or two BILAG B grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment period. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to systemic lupus erythematosus (SLE), divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.

DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Change From Baseline in Prednisone-equivalent CS Daily Dose at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.

DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Number of Participants With Reduction From Baseline in Prednisone-equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.

DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52

Cumulative Prednisone-equivalent Corticosteroid (CS) Dose was calculated at Week 52.

DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52

SRI-4 response was defined as greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).

DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on SRI-4 at Week 52 in Serologically Active Subgroup

SRI-4 response was defined as greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well(0)-very poor(100).

DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52

Lupus low disease activity state will be measured as: SLEDAI-2K <= 4; No activity in any major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever); No new features of disease activity compared with the previous assessment; Prednisone-equivalent <= 7.5 milligram per day; Unchanged background immunosuppressive therapy.

Full Information

NCT ID

NCT02975336

First Posted

November 23, 2016

Last Updated

March 16, 2021

Sponsor

EMD Serono Research & Development Institute, Inc.

Collaborators

Merck KGaA, Darmstadt, Germany

1. Study Identification

Unique Protocol Identification Number

NCT02975336

Brief Title

A Phase II Study of M2951 in SLE

Official Title

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With SLE

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Terminated

Why Stopped

Study is completed; primary analysis completed.

Study Start Date

January 4, 2017 (Actual)

Primary Completion Date

November 27, 2019 (Actual)

Study Completion Date

March 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMD Serono Research & Development Institute, Inc.

Collaborators

Merck KGaA, Darmstadt, Germany

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus, M2951, Placebo, Dose response, Oral Corticosteroids, Safety, Efficacy, Autoimmune And Inflammatory Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

469 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Double-Blind Placebo-Controlled (DBPC) Period: Placebo

Arm Type

Placebo Comparator

Arm Title

DBPC Period: M2951 25 mg QD

Arm Type

Experimental

Arm Title

DBPC Period: M2951 75 mg QD

Arm Type

Experimental

Arm Title

DBPC Period: M2951 50 mg BID

Arm Type

Experimental

Arm Title

Long-Term Extension (LTE) Period: Placebo/ M2951 50 mg BID

Arm Type

Experimental

Arm Title

LTE Period: M2951 25 mg QD/ M2951 50 mg BID

Arm Type

Experimental

Arm Title

LTE Period: M2951 75 mg QD/ M2951 50 mg BID

Arm Type

Experimental

Arm Title

LTE Period: M2951 50 mg BID/ M2951 50 mg BID

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants received placebo matched to M2951 orally for 52 weeks.

Intervention Type

Drug

Intervention Name(s)

M2951

Other Intervention Name(s)

Evobrutinib

Intervention Description

Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.

Intervention Type

Drug

Intervention Name(s)

M2951

Other Intervention Name(s)

Evobrutinib

Intervention Description

Participants received 75 mg of M2951 orally QD for 52 weeks.

Intervention Type

Drug

Intervention Name(s)

M2951

Other Intervention Name(s)

Evobrutinib

Intervention Description

Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.

Intervention Type

Drug

Intervention Name(s)

M2951

Other Intervention Name(s)

Evobrutinib

Intervention Description

Participants who had received Placebo or M2951 (25 mg QD, 75 mg QD or 50 mg BID) during DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.

Primary Outcome Measure Information:

Title

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52

Description

Time Frame

Week 52

Title

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52

Description

Time Frame

Week 52

Title

Description

Time Frame

Baseline up to Week 56

Title

Description

Time Frame

Baseline up to Week 56

Title

DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Description

Time Frame

Baseline up to Week 56

Title

DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings

Description

Time Frame

Baseline up to Week 56

Title

DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters

Description

Time Frame

Baseline up to Week 56

Title

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2

Description

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 2.

Time Frame

Week 2

Title

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4

Description

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 4.

Time Frame

Week 4

Title

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12

Description

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 12.

Time Frame

Week 12

Title

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24

Description

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 24.

Time Frame

Week 24

Title

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36

Description

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 36.

Time Frame

Week 36

Title

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52

Description

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 52

Time Frame

Week 52

Title

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56

Description

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 56

Time Frame

Week 56

Title

DBPC Period: Mean Absolute Total B Cell Count at Week 4

Description

Mean total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.

Time Frame

Week 4

Title

DBPC Period: Mean Absolute Total B Cell Count at Week 24

Description

Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.

Time Frame

Week 24

Title

DBPC Period: Mean Absolute Total B Cell Count at Week 52

Description

Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.

Time Frame

Week 52

Title

DBPC Period: Mean Absolute Total B Cell Count at Week 56

Description

Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.

Time Frame

Week 56

Title

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2

Description

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time Frame

Baseline and Week 2

Title

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4

Description

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time Frame

Baseline and Week 4

Title

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12

Description

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time Frame

Baseline and Week 12

Title

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24

Description

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time Frame

Baseline and Week 24

Title

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36

Description

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time Frame

Baseline and Week 36

Title

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52

Description

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time Frame

Baseline and Week 52

Title

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56

Description

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time Frame

Baseline and Week 56

Title

DBPC Period: Change From Baseline in Total B Cell Count at Week 4

Description

Time Frame

Baseline and Week 4

Title

DBPC Period: Change From Baseline in Total B Cell Count at Week 24

Description

Time Frame

Baseline and Week 24

Title

DBPC Period: Change From Baseline in Total B Cell Count at Week 52

Description

Time Frame

Baseline and Week 52

Title

DBPC Period: Change From Baseline in Total B Cell Count at Week 56

Description

Time Frame

Baseline and Week 56

Secondary Outcome Measure Information:

Title

DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare

Description

Time Frame

Baseline up to Week 56

Title

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup

Description

SRI-4 response was defined as greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).

Time Frame

Week 52

Title

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup

Description

Time Frame

Week 52

Title

DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare

Description

BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. A Moderate to Severe (BILAG A or 2B) flare is defined as at least one BILAG A (severe disease activity) grade or two BILAG B (moderate disease activity) grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment. It was measured using Kaplan-Meier (KM) estimates.

Time Frame

Baseline up to Week 56

Title

DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period

Description

Time Frame

up to Week 52

Title

DBPC Period: Annualized Flare Rate

Description

Time Frame

Baseline up to Week 52

Title

DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52

Description

Time Frame

Week 52

Title

Description

Time Frame

Week 52

Title

DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Description

Time Frame

Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Title

DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Description

Time Frame

Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Title

DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52

Description

Time Frame

Week 52

Title

DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Description

Time Frame

Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Title

DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Description

Time Frame

Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Title

Description

Time Frame

Baseline, Week 4, 8, 12, 16, 24, 32, 40 and 52

Title

DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52

Description

Time Frame

Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52

Title

DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52

Description

The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.

Time Frame

Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52

Title

DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52

Description

Time Frame

Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52

Title

DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening

Description

Time Frame

Week 4, 8, 12, 16, 24, 32, 40, and 52

Title

DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52

Description

Time Frame

Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52

Title

Description

Time Frame

Baseline and Week 52

Title

DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Description

Change From Baseline in Prednisone-equivalent CS Daily Dose at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.

Time Frame

Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Title

Description

Time Frame

Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Title

DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52

Description

Cumulative Prednisone-equivalent Corticosteroid (CS) Dose was calculated at Week 52.

Time Frame

Week 52

Title

Description

SRI-4 response was defined as greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).

Time Frame

Week 52

Title

Description

Time Frame

Week 52

Title

Description

SRI-4 response was defined as greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well(0)-very poor(100).

Time Frame

Week 52

Title

DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52

Description

Time Frame

Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eligible male and female participants, aged 18 to 75 years Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI greater than or equal to (>=) 4) at Screening Visit And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening Other protocol defined inclusion criteria could apply Exclusion Criteria: Participants are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg) Acutely worsened renal function Central nervous system SLE Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (>) 30 mg daily prednisone equivalent Use of injectable corticosteroids, or change in dose of corticosteroids. Other protocol defined exclusion criteria could apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Responsible

Organizational Affiliation

EMD Serono Research & Development Institute, Inc., a business of Merck KGaA, Darmstadt, Germany

Official's Role

Study Director

Facility Information:

Facility Name

Pinnacle Research Group LLC

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Associates, P.C.

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Associates, P.C.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Advanced Research Center, Inc.

City

Anaheim

State/Province

California

ZIP/Postal Code

92805

Country

United States

Facility Name

Wallace Rheumatic Study Center

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Medvin Clinical Research

City

Covina

State/Province

California

ZIP/Postal Code

91722

Country

United States

Facility Name

Southern California Permanent Medical Group

City

Fontana

State/Province

California

ZIP/Postal Code

92335

Country

United States

Facility Name

Global Research Management

City

Glendale

State/Province

California

ZIP/Postal Code

91204

Country

United States

Facility Name

University of Southern California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

East Bay Rheumatology Medical Group, Inc.

City

San Leandro

State/Province

California

ZIP/Postal Code

94578

Country

United States

Facility Name

Inland Rheumatology Clinical Trials, Inc.

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Nazanin Firooz, MD Inc.

City

West Hills

State/Province

California

ZIP/Postal Code

91307

Country

United States

Facility Name

University of Colorado Denver Anschutz Medical Campus

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Yale School Of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Facility Name

Clinical Research of West Florida - Corporate

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Omega Research Consultants

City

DeBary

State/Province

Florida

ZIP/Postal Code

32713

Country

United States

Facility Name

Center for Rheumatology, Immunology & Arthritis

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33309

Country

United States

Facility Name

Hope Clinical Trials

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

IRIS Research and Development

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

McIlwain Medical Group, PA

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Meridien Research, Inc.

City

Tampa

State/Province

Florida

ZIP/Postal Code

33634

Country

United States

Facility Name

Marietta Rheumatology Associates, PC

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

The University of Chicago Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

LSU Health Sciences Center Gastroenterology

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71103

Country

United States

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Henry Ford Health System

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

AA MRC LLC Ahmed Arif Medical Research Center

City

Flint

State/Province

Michigan

ZIP/Postal Code

48439

Country

United States

Facility Name

University of Mississippi Medical Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Washington University in St. Louis

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Montefiore Medical Center PRIME

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Hospital for Special Surgery

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

SUNY Upstate Medical Center

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Medication Management, LLC

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Allegheny-Singer Research Institute

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Innovative Clinical Research, LLC

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

Metroplex Clinical Research Center, LLC

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Accurate Clinical Research, Inc.

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

Accurate Clinical Management - Brionez

City

Houston

State/Province

Texas

ZIP/Postal Code

77084

Country

United States

Facility Name

Medical Center Research, LLC Webster Office

City

Pearland

State/Province

Texas

ZIP/Postal Code

77584

Country

United States

Facility Name

DM Clinical Research

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

FSAEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF

City

Seattle

State/Province

Washington

Country

United States

Facility Name

Instituto de Investigaciones Clinicas

City

Mar del Plata

State/Province

Buenos Aires

Country

Argentina

Facility Name

Instituto de Investigaciones Clinicas Quilmes

City

Quilmes

State/Province

Buenos Aires

Country

Argentina

Facility Name

Centro Medico Privado de Reumatologia

City

San Miguel de Tucuman

State/Province

Tucuman

Country

Argentina

Facility Name

Investigaciones Clinicas Tucuman

City

San Miguel de Tucuman

State/Province

Tucuman

Country

Argentina

Facility Name

Centro Integral de Reumatologia

City

San Miguel de Tucumán

State/Province

Tucuman

Country

Argentina

Facility Name

APRILLUS

City

Ciudad Autonoma Buenos aires

Country

Argentina

Facility Name

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

City

Ciudad Autonoma Buenos Aires

Country

Argentina

Facility Name

Clinica Adventista Belgrano

City

Ciudad Autonoma Buenos Aires

Country

Argentina

Facility Name

Hospital Britanico de Buenos Aires

City

Ciudad Autonoma Buenos Aires

Country

Argentina

Facility Name

Hospital General de Agudos Dr. J. M. Ramos Mejia

City

Ciudad Autonoma Buenos Aires

Country

Argentina

Facility Name

Sanatorio Allende

City

Cordoba

Country

Argentina

Facility Name

Instituto de Reumatologia

City

Mendoza

Country

Argentina

Facility Name

Cordis S.A.

City

Salta

Country

Argentina

Facility Name

Centro Polivalente de Asistencia e Inv. Clinica CER

City

San Juan

Country

Argentina

Facility Name

UMHAT "Pulmed" OOD

City

Plovdiv

Country

Bulgaria

Facility Name

MHAT - Ruse, AD

City

Ruse

Country

Bulgaria

Facility Name

Medizinski Zentar-1-Sevlievo EOOD

City

Sevlievo

Country

Bulgaria

Facility Name

Medical Center "Excelsior", OOD

City

Sofia

Country

Bulgaria

Facility Name

Medical Center Comac Medical EOOD

City

Sofia

Country

Bulgaria

Facility Name

UMHAT "SofiaMed", OOD

City

Sofia

Country

Bulgaria

Facility Name

UMHAT "Sv. Ivan Rilski", EAD

City

Sofia

Country

Bulgaria

Facility Name

Corporacion de Beneficencia Osorno

City

Osorno

Country

Chile

Facility Name

Centro de Estudios Reumatologicos

City

Santiago

Country

Chile

Facility Name

Centro Medico Prosalud

City

Santiago

Country

Chile

Facility Name

Interin

City

Santiago

Country

Chile

Facility Name

Psicomedica Clinical and Research Group

City

Santiago

Country

Chile

Facility Name

Quantum Research Santiago

City

Santiago

Country

Chile

Facility Name

Centro de Reumatologia y Ortopedia SAS

City

Barranquilla

Country

Colombia

Facility Name

Clínica de la Costa Ltda.

City

Barranquilla

Country

Colombia

Facility Name

Fundacion Instituto de Reumatologia Fernando Chalem

City

Bogota

Country

Colombia

Facility Name

Simedics Ips Sas

City

Bogotá

Country

Colombia

Facility Name

Servimed S.A.S.

City

Bucaramanga

Country

Colombia

Facility Name

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

City

Berlin

Country

Germany

Facility Name

Humanitas Research Hospital

City

Rozzano

State/Province

Milano

Country

Italy

Facility Name

Ospedale San Raffaele

City

Milano

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

City

Napoli

Country

Italy

Facility Name

Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

City

Reggio Emilia

Country

Italy

Facility Name

Policlinico Universitario Agostino Gemelli

City

Roma

Country

Italy

Facility Name

Ehime University Hospital

City

Toon-shi

State/Province

Ehime-Ken

Country

Japan

Facility Name

Tobata General Hospital

City

Kitakyushu-shi

State/Province

Fukuoka-Ken

Country

Japan

Facility Name

University of Occupational and Environmental Health Hospital

City

Kitakyushu-shi

State/Province

Fukuoka-Ken

Country

Japan

Facility Name

NHO Asahikawa Medical Center

City

Asahikawa-shi

State/Province

Hokkaido

Country

Japan

Facility Name

Kanazawa University Hospital

City

Kanazawa-shi

State/Province

Ishikawa-Ken

Country

Japan

Facility Name

Kagawa University Hospital

City

Kita-gun

State/Province

Kagawa-Ken

Country

Japan

Facility Name

Eiraku Clinic

City

Kagoshima-shi

State/Province

Kagoshima-Ken

Country

Japan

Facility Name

Tohoku University Hospital

City

Sendai-shi

State/Province

Miyagi-Ken

Country

Japan

Facility Name

Seirei Hamamatsu General Hospital

City

Hamamatsu-shi

State/Province

Shizuoka-Ken

Country

Japan

Facility Name

Dokkyo Medical University Hospital

City

Shimotsuga-gun

State/Province

Tochigi-Ken

Country

Japan

Facility Name

St. Luke's International Hospital

City

Chuo-ku

State/Province

Tokyo-To

Country

Japan

Facility Name

Tokyo Metropolitan Tama Medical Center

City

Fuchu-shi

State/Province

Tokyo-To

Country

Japan

Facility Name

Nihon University Itabashi Hospital

City

Itabashi-ku

State/Province

Tokyo-To

Country

Japan

Facility Name

Keio University Hospital

City

Shinjuku-ku

State/Province

Tokyo-To

Country

Japan

Facility Name

Tottori University Hospital

City

Yonago-shi

State/Province

Tottori-Ken

Country

Japan

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

Country

Korea, Republic of

Facility Name

Ajou University Hospital

City

Suwon-si

State/Province

Gyeonggi-do

Country

Korea, Republic of

Facility Name

Dong-A University Hospital

City

Busan

Country

Korea, Republic of

Facility Name

Kyungpook National University Hospital

City

Daegu

Country

Korea, Republic of

Facility Name

Konkuk University Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei University

City

Seoul

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Yeouido St. Mary's Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Hospital Pakar Sultanah Fatimah

City

Muar

State/Province

Johor

Country

Malaysia

Facility Name

Hospital Umum Sarawak

City

Kuching

State/Province

Sarawak

Country

Malaysia

Facility Name

Hospital Selayang

City

Batu Caves

State/Province

Selangor

Country

Malaysia

Facility Name

International Medical University (IMU) Healthcare

City

Bukit Jalil

State/Province

Selangor

Country

Malaysia

Facility Name

Hospital Kuala Lumpur

City

Kuala Lumpur

Country

Malaysia

Facility Name

CAP Research

City

Solferino-Phoenix

Country

Mauritius

Facility Name

Unidad de Investigacion de las Enfermedades Reumaticas

City

Cuauhtemoc

State/Province

Distrito Federal

Country

Mexico

Facility Name

Clinstile, S.A. de C.V.

City

Mexico

State/Province

Distrito Federal

Country

Mexico

Facility Name

Clinical Research Institute S.C.

City

Tlalnepantla

State/Province

Estado De Mexico

Country

Mexico

Facility Name

Morales Vargas Centro de Investigacion, S.C.

City

Leon

State/Province

Guanajuato

Country

Mexico

Facility Name

Clinica de Investigacion en Reumatologia y Obesidad S.C.

City

Guadalajara

State/Province

Jalisco

Country

Mexico

Facility Name

Unidad de Investigacion en Enfermedades Cronico Degenerativas SC

City

Guadalajara

State/Province

Jalisco

Country

Mexico

Facility Name

Accelerium S. de R.L. de C.V.

City

Monterrey

State/Province

Nuevo León

Country

Mexico

Facility Name

Hospital Central Dr Ignacio Morones Prieto

City

San Luis Potosi

State/Province

San Luis Potos

Country

Mexico

Facility Name

Investigacion y Biomedicina de Chihuahua, S.C.

City

Chihuahua

Country

Mexico

Facility Name

Hogar Clínica San Juan de Dios - Arequipa

City

Arequipa

Country

Peru

Facility Name

Clinica El Golf

City

Lima

Country

Peru

Facility Name

Clinica Medica Cayetano Heredia

City

Lima

Country

Peru

Facility Name

Clinica San Juan Bautista

City

Lima

Country

Peru

Facility Name

Clinica Vesalio

City

Lima

Country

Peru

Facility Name

GINOBS SA. Instituto de Ginecologia y Reproduccion

City

Lima

Country

Peru

Facility Name

Hospital Nacional Cayetano Heredia

City

Lima

Country

Peru

Facility Name

University of Washington Medical Center

City

Lima

Country

Peru

Facility Name

ICCV Research Instituto del Cerebro y la Columna Vertebral

City

Miraflores

Country

Peru

Facility Name

Angeles University Foundation Medical Center

City

Angeles City, Pampanga

Country

Philippines

Facility Name

Mary Mediatrix Medical Center

City

Batangas

Country

Philippines

Facility Name

De La Salle University Medical Center

City

Dasmariñas City, Cavite

Country

Philippines

Facility Name

Davao Doctors Hospital

City

Davao City

Country

Philippines

Facility Name

Southern Philippines Medical Center

City

Davao City

Country

Philippines

Facility Name

Iloilo Doctors Hospital

City

Iloilo City

Country

Philippines

Facility Name

St. Luke's Medical Center

City

Quezon City

Country

Philippines

Facility Name

CERMED

City

Bialystok

Country

Poland

Facility Name

Szpital Uniwersytecki nr 2 im.dr J. Biziela

City

Bydgoszcz

Country

Poland

Facility Name

Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek. Barbara Bazela

City

Elblag

Country

Poland

Facility Name

Centrum Medyczne Plejady

City

Krakow

Country

Poland

Facility Name

Nzoz Atopia

City

Krakow

Country

Poland

Facility Name

Rheuma Medicus Zaklad

City

Warsawa

Country

Poland

Facility Name

Spitalul Clinic "Dr.I. Cantacuzino"

City

Bucuresti

Country

Romania

Facility Name

Spitalul Clinic "Sf. Maria"

City

Bucuresti

Country

Romania

Facility Name

S.C Mediab S.R.L

City

Tirgu Mures

Country

Romania

Facility Name

LLC "Alliance Biomedical - Ural Group"

City

Izhevsk

Country

Russian Federation

Facility Name

TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich

City

Krasnoyarsk

Country

Russian Federation

Facility Name

HMA - Hospital Maria Auxiliadora

City

Moscow

Country

Russian Federation

Facility Name

Ultramed

City

Omsk

Country

Russian Federation

Facility Name

LLC Medical Sanitary Unit#157

City

Saint-Petersburg

Country

Russian Federation

Facility Name

SPb SBIH "Clinical Rheumatological Hospital # 25"

City

Saint-Petersburg

Country

Russian Federation

Facility Name

SIH "Saratov City Clinical Hospital # 12"

City

Saratov

Country

Russian Federation

Facility Name

Research Institute of Emergency Medical Care

City

St. Petersburg

Country

Russian Federation

Facility Name

Nebbiolo LLC

City

Tomsk

Country

Russian Federation

Facility Name

Wits Clinical Research

City

Johannesburg

State/Province

Gauteng

Country

South Africa

Facility Name

Winelands Medical Research Centre

City

Stellenbosch

State/Province

Western Cape

Country

South Africa

Facility Name

Naidoo, A - Netcare Umhlanga Hospital

City

Durban

ZIP/Postal Code

4319

Country

South Africa

Facility Name

Kaohsiung Chang Gung Memorial Hospital

City

Kaohsiung

Country

Taiwan

Facility Name

Kaohsiung Medical University Chung-Ho Memorial Hospital

City

Kaohsiung

Country

Taiwan

Facility Name

Taichung Veterans General Hospital

City

Taichung

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

33687069

Citation

Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Results Reference

derived

Links:

URL

https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200527-0018

Description

Trial Awareness and Transparency website

URL

https://medical.emdserono.com/en_US/home.html

Description

US Medical Information website, Medical Resources

Learn more about this trial

A Phase II Study of M2951 in SLE

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