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Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cenerimod 0.5 mg
Cenerimod 1 mg
Cenerimod 2 mg
Cenerimod 4 mg
Placebo
cenerimod 2 mg (ex-4 mg)
Sponsored by
Idorsia Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Musculoskeletal and connective tissue disorders

Eligibility Criteria

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

Inclusion Criteria:

  • Signed Informed Consent Form prior to any study-mandated procedure
  • Diagnosis of SLE made at least 6 months prior to Screening, by fulfilling at least 4 of the 11 criteria for SLE as defined by the American College of Rheumatology (ACR) criteria
  • A mSLEDAI-2K score ≥ 6 of at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).

  • Currently treated with stable doses of one or more of the following background medications:

    • NSAIDs
    • Anti-malarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine)
    • Mycophenolate mofetil (≤ 2 g/day)
    • Mycophenolic acid (≤ 1440 mg/day)
    • Azathioprine (≤ 2 mg/kg/day)
    • Methotrexate (≤ 20 mg/week)
    • Corticosteroids (≤ 40 mg/day prednisone or equivalent)
    • Belimumab (≤10 mg/kg every 4 weeks intravenously, or 200 mg/week subcutaneously).
  • History or presence of positive autoantibodies measured by central laboratory defined as follows: (a) Positive antinuclear antibody (ANA) test measured by immunofluorescence assay (IFA) with titre ≥1:80; AND/OR (b) positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies with titre ≥30 IU/mL

  • Women of childbearing potential:

    • Must have a negative serum pregnancy test at Screening
    • Must agree to undertake monthly urine pregnancy tests during the study
    • Must use highly effective methods of contraception from the screening visit until 6 months after taking the last dose of study treatment.

Exclusion Criteria:

  • Active lupus nephritis or a renal biopsy demonstrating immune complex mediated glomerulonephritis compatible with lupus nephritis.
  • CNS (Central Nervous System) lupus and severe forms of vasculitis requiring systemic immunosuppressive treatment
  • A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with rheumatoid arthritis, erosive arthritis, scleroderma or autoimmune hepatitis
  • History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia or syncope associated with cardiac disorders
  • Subjects who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure defined by the New York Heart Association Class III/IV within six months prior to Screening
  • An elevated QT corrected for HR (Heart Rate) on the basis of Fridericia's formula interval of > 470 ms (females) / > 450 ms (males)
  • History or presence of severe respiratory disease or pulmonary fibrosis
  • Active or latent tuberculosis
  • Ongoing bacterial, viral or fungal infection that is of clinical concern in the judgment of the investigator or history of any serious infection
  • Subjects who have congenital or acquired severe immunodeficiency or known HIV infection or positive HIV testing
  • Presence of macular edema or active uveitis
  • Type 1 or 2 diabetes that is poorly controlled according to investigator judgment, or diabetes complicated with organ involvement such as diabetic nephropathy or retinopathy
  • Significant hematology abnormality: Lymphocyte count < 800 /μL (0.8 × 10e9/L); hemoglobin < 9 g/dL; WBC (White Blood Cell) count < 2500/μL (2.5 × 10e9/L) or platelets < 75000/μL (75 × 10e9/L)
  • Estimated glomerular filtration rate < 60 mL/min/1.73 m2
  • Known allergy to S1P (sphingosine-1-phosphate) receptor modulators or any of the cenerimod formulation excipients

Sites / Locations

  • Pinnacle Research Group
  • University of California San Diego
  • Valerius Medical Group and Research Center
  • University of Colorado School of Medicine
  • Robert W Levin MD PA
  • Center for Rheumatology Immunology and Arthritis
  • Life Clinical Trials
  • San Marcus Research Clinic
  • D&H National Research Centers INC
  • Millennium Research
  • Integral Rheumatology & Immunology Specialists
  • Advanced Research Institute Inc Allergy & Rheumatology
  • Axiom Clinical Research of Florida
  • North Georgia Rheumatology Group - Duluth
  • Institute of Arthritis Research
  • Washington University School of Medicine
  • Innovative Health Research
  • New York Presbyterian Columbia University Medical Center
  • State University of New York Upstate Medical University
  • Joint Muscle Medical Care and Research Institute - Lilington Office
  • DJL Clinical Research
  • Paramount Medical Research and Consulting
  • Altoona Center for Clinical Research
  • Office of Ramesh C. Gupta, MD
  • Amarillo Center for Clinical Research
  • Accurate Clinical Research
  • Southwest Rheumatology Research, LLC
  • Sun Research Institute
  • Accurate Clinical Management
  • Multiprofile Hospital For Active Treatment Trimontium
  • University Multiprofile Hospital for Active Treatment Pulmed
  • Diagnostic and Consulting Center "Aleksandrovska" EOOD
  • Diagnostic Consulting Center Fokus-5
  • Enroll SpA
  • Biomedica Research Group
  • Meditek Ltda.
  • Prosalud
  • Clinical Research Chile SpA
  • CCR Pardubice
  • Centre Hospitalier Regional Universitaire Brest Hôpital de la Cavale Blanche à Brest
  • Hôpital Haut-Lévêque
  • LTD "New Plasma Clinic"
  • Aversi Clinic LTD
  • Medi Club Georgia Ltd.
  • Ltd. Mtskheta Street Clinic
  • The First Medical Center Ltd.
  • LLC "Innova"
  • LLC Raymann
  • LTD "Tbilisi Heart Center"
  • Medicore
  • Multiprofile Clinic Consilium Medulla
  • Städtisches Klinikum Karlsruhe gGmbH
  • General Hospital of Athens "Laiko"
  • Egyesitett Szent Istvan es Szent Laszlo Korhaz Rendelointezet
  • Rambam Healthcare Campus
  • Bnai Zion Medical Center
  • Galilee Medical Center
  • The Chaim Sheba Medical Center
  • LUPUS CLINIC c/o DIMI
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Ospedale San Raffaele
  • Azienda Ospedaliera San Camillo Forlanini
  • Fondazione Policlinico Universitario A. Gemelli
  • A.O. Mauriziano Umberto I di Torino
  • Tomakomai City Hospital
  • Karla Adriana Espinosa Bautista
  • Consultorio Particular Dr. Miguel Cortés Hernández
  • Centro Integral en Reumatología S.A. de C.V.
  • Icle S.C.
  • Consultorio Privado de Especialidad del Dr. José Javier Orozco Alcalá
  • Consultorio Médico del Dr. Federico Galván Villegas
  • Morales Vargas Centro de Investigación S.C.
  • Centro de Investigación Clínica GRAMEL, S.C.
  • Biológicos Especializados S.A. de C.V.
  • Accelerium, S. de R.L. de C.V.
  • UBAM Unidad Biomédica Avanzada Monterrey
  • Unidad de Atención Médica e Investigación en Salud
  • Kohler & Milstein Research S.A. de C.V.
  • SMIQ, S. de R.L. de C.V.
  • Hospital Universitario "Dr. Gonzalo Valdés Valdés"
  • Unidad de Investigaciones Reumatológicas A.C.
  • Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
  • Lipa Medix Medical Center
  • Angeles University Foundation Medical Center
  • Davao Doctors Hospital
  • Iloilo Doctors Hospital
  • Makati Medical Center
  • University of the Philippines Manila - Philippine General Hospital
  • Jose R. Reyes Memorial Medical Center
  • University of Santo Tomas Hospital
  • St. Luke's Medical Center
  • Far Eastern University - Nicanor Reyes Medical Foundation
  • Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy
  • Intermedius Uslugi Medyczne
  • Szpital Specjalistyczny im. J. Dietla w Krakowie
  • Centrum Medyczne Plejady
  • Twoja Przychodnia Poznańskie Centrum Medyczne
  • Śląskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepełnosprawności im gen. Jerzego Zi
  • Centro Reumatologico de Caguas
  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
  • Spitalul Clinic "Sf. Maria"
  • SC Sana Monitoring SRL
  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca
  • Chelyabinsk Regional Clinical Hospital
  • JSC "Center of Family Medicine"
  • City Clinical Hospital #15 named after O.M. Filatova
  • Federal State Budget Scientific Research Institution "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"
  • Non-governmental private healthcare organization, Scientific Clinical Centre of JSC Russian Railways
  • Medical Center "Zdorovaya Semiya", LLC
  • Orenburg State Medical University
  • Clinical Rheumatological Hospital Number 25
  • Polyclinic of Private Security and Detectives
  • Medical Research Institute, LLC
  • Medical Center Maksimum Zdorovia
  • Military Medical Academy S.M. Kirov
  • Saratov Regional Clinical Hospital
  • State Institution of Health Protection "Clinical Hospital #8"
  • Hospital Universitario Regional de Málaga
  • Hospital Clinic i Provincial de Barcelona
  • Hospital Universitario 12 de Octubre
  • Hospital Quirónsalud Infanta Luisa
  • Hospital Universitario Doctor Peset
  • Kaohsiung Medical University Hospital
  • Kaohsiung Veterans General Hospital
  • Rajavithi Hospital
  • Songklanagarind Hospital
  • Istanbul Universitesi Istanbul Tip Fakultesi
  • Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi
  • Kyiv City Clinical Hospital №3
  • Clinic of State Institution "National Scientific Centre "Acad. Strazhesko Institute of Cardiology"
  • Medical Centre "Consilium medical"
  • Municipal Institution Kyiv Regional Council "Kyiv Regional Clinical Hospital"
  • Municipal Nonprofit Institution of Lviv Regional Council "Lviv Regional Clinical Hospital"
  • Municipal Nonprofit Institution of Lviv Regional Council
  • Lviv Regional Clinical Hospital
  • Poltava Regional Clinical Hospital named after M.V. Sklifossovsky
  • Ternopil University Clinic - Rheumatology department
  • Zakarpattya Regional Clinical Hospital n.a. A.Novak - Rheumatology Department
  • Private Small Scale Medical Center "Pulse"
  • Medical Center "Health Clinic", LLC
  • Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital №1"
  • Scientific and Research Institute of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU,
  • Vinnytsya Regional Clinical Hospital - Rheumatology Department
  • Municipal Institution "Zaporizhzhya Regional Clinical Hospital"
  • Municipal institution "Regional Clinical Hospital n.a. O.F. Herbachevskoho"
  • Cambridge University Hospitals NHS Foundation Trust
  • Guy's and Saint Thomas' NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Cenerimod 0.5 mg

Cenerimod 1 mg

Cenerimod 2 mg

Cenerimod 2 mg (Ex-4mg)

Placebo (Ex-4mg)

Cenerimod 4 mg

Placebo

Arm Description

Participants will receive cenerimod 0.5 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 0.5 mg for a further 6 months and end study treatment at the Month 12 visit.

Participants will receive cenerimod 1 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 1 mg for a further 6 months and end study treatment at the Month 12 visit.

Participants will receive cenerimod 2 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 2 mg for a further 6 months and end study treatment at the Month 12 visit.

Half the participants that complete treatment with cenerimod 4 mg in Treatment Period 1 will be re-randomized to cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2. Participants will receive cenerimod 2 mg for 6 months and end study treatment at the Month 12 visit.

Half the participants that complete treatment with cenerimod 4 mg in Treatment Period 1 will be re-randomized to placebo (matching cenerimod) once daily in addition to background SLE therapy during Treatment Period 2. Participants will receive cenerimod 2 mg for 6 months and end study treatment at the Month 12 visit.

Participants will received cenerimod 4 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1. The participants randomized to the 4 mg treatment who were still on treatment at Month 6 were re-randomized in a 1:1 ratio to placebo or cenerimod 2 mg to enter Treatment Period 2. The participants who did not complete 6 months of cenerimod 4 mg treatment will be analyzed in the "Non Re-randomized (Ex-4mg)" treatment group.

Participants will receive placebo (matching cenerimod) once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with placebo (matching cenerimod) for a further 6 months and end study treatment at the Month 12 visit.

Outcomes

Primary Outcome Measures

Change From Baseline to Month 6 in the Modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) Score
The primary endpoint is the absolute change from baseline in the modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) score. The SLEDAI-2K is a cumulative index of lupus disease activity scored by the physician. It is calculated from 24 individual descriptors across 9 organ systems, with weighted scores of 2-8, and measures disease activity within the last 10 days. 0 points indicates inactive disease, and 105 points is the maximum possible score. In this study the SLEDAI-2K was modified, to exclude leucopenia (minus 1 point), due to the mechanism of action of cenerimod. Improvement in systemic lupus erythematosus disease activity is defined as a reduction in SLEDAI-2K score of greater than or equal to 4. A decreased score, i.e., a negative change, indicates an improvement in systemic lupus erythematosus disease activity from baseline to Month 6.

Secondary Outcome Measures

Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 6 as Compared to Baseline
A responder could only be assessed if the full information of all body systems was available. A participant was defined as a responder based on the Systemic Lupus Erythematosus Responder Index 4 (SRI-4) was a composite, binary endpoint based on three variables: mSLEDAI-2K score had to have a reduction from baseline greater than or equal to 4, Physician Global Assessment (PGA) had to have an increase from baseline less than or equal to 0.3. The PGA is a 100 mm visual analog scale used by the physician to assess disease activity ranging for 0 to 3. The scale is anchored with values from 0 = "none" and 3 = "severe"), and BILAG-2004 (no new BILAG A organ domain score and at most one new BILAG B organ domain score) compared with baseline. If one of the SRI-4 mSLEDAI-2K, PGA and BILAG variables were not met the subject was scored a non-responder. Participants that did not fit at least one of the above criteria were assigned to the missing group.
British Isles Lupus Assessment Group-2004 (BILAG) Disease Activity Index Response at Month 6
The British Isles Lupus Assessment Group-2004 (BILAG) is a comprehensive tool used by the physician to assess disease activity and is sensitive to small changes over time. Response (no worsening) at Month 6 on BILAG-2004 disease activity index was defined as no new BILAG A organ domain score and no more than one new BILAG B organ domain score compared with baseline. No analysis is reported because the model did not meet the convergence criteria.

Full Information

First Posted
November 12, 2018
Last Updated
September 20, 2023
Sponsor
Idorsia Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03742037
Brief Title
Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Official Title
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idorsia Pharmaceuticals Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE).
Detailed Description
This is a Phase 2b, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with moderately to severely active, autoantibody-positive 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
Musculoskeletal and connective tissue disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants randomized to the 4 mg arm who are still on treatment at month 6 will be re-randomized in a 1:1 ratio to placebo or cenerimod 2 mg to enter Treatment Period 2 and will continue study treatment for a total maximum of 12 months.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
427 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cenerimod 0.5 mg
Arm Type
Experimental
Arm Description
Participants will receive cenerimod 0.5 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 0.5 mg for a further 6 months and end study treatment at the Month 12 visit.
Arm Title
Cenerimod 1 mg
Arm Type
Experimental
Arm Description
Participants will receive cenerimod 1 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 1 mg for a further 6 months and end study treatment at the Month 12 visit.
Arm Title
Cenerimod 2 mg
Arm Type
Experimental
Arm Description
Participants will receive cenerimod 2 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 2 mg for a further 6 months and end study treatment at the Month 12 visit.
Arm Title
Cenerimod 2 mg (Ex-4mg)
Arm Type
Experimental
Arm Description
Half the participants that complete treatment with cenerimod 4 mg in Treatment Period 1 will be re-randomized to cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2. Participants will receive cenerimod 2 mg for 6 months and end study treatment at the Month 12 visit.
Arm Title
Placebo (Ex-4mg)
Arm Type
Placebo Comparator
Arm Description
Half the participants that complete treatment with cenerimod 4 mg in Treatment Period 1 will be re-randomized to placebo (matching cenerimod) once daily in addition to background SLE therapy during Treatment Period 2. Participants will receive cenerimod 2 mg for 6 months and end study treatment at the Month 12 visit.
Arm Title
Cenerimod 4 mg
Arm Type
Experimental
Arm Description
Participants will received cenerimod 4 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1. The participants randomized to the 4 mg treatment who were still on treatment at Month 6 were re-randomized in a 1:1 ratio to placebo or cenerimod 2 mg to enter Treatment Period 2. The participants who did not complete 6 months of cenerimod 4 mg treatment will be analyzed in the "Non Re-randomized (Ex-4mg)" treatment group.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo (matching cenerimod) once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with placebo (matching cenerimod) for a further 6 months and end study treatment at the Month 12 visit.
Intervention Type
Drug
Intervention Name(s)
Cenerimod 0.5 mg
Intervention Description
Cenerimod will be supplied as a film-coated tablets at the dose of 0.5 mg
Intervention Type
Drug
Intervention Name(s)
Cenerimod 1 mg
Intervention Description
Cenerimod will be supplied as a film-coated tablets at the dose of 1 mg
Intervention Type
Drug
Intervention Name(s)
Cenerimod 2 mg
Intervention Description
Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg
Intervention Type
Drug
Intervention Name(s)
Cenerimod 4 mg
Intervention Description
Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod
Intervention Type
Drug
Intervention Name(s)
cenerimod 2 mg (ex-4 mg)
Intervention Description
Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg
Primary Outcome Measure Information:
Title
Change From Baseline to Month 6 in the Modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) Score
Description
The primary endpoint is the absolute change from baseline in the modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) score. The SLEDAI-2K is a cumulative index of lupus disease activity scored by the physician. It is calculated from 24 individual descriptors across 9 organ systems, with weighted scores of 2-8, and measures disease activity within the last 10 days. 0 points indicates inactive disease, and 105 points is the maximum possible score. In this study the SLEDAI-2K was modified, to exclude leucopenia (minus 1 point), due to the mechanism of action of cenerimod. Improvement in systemic lupus erythematosus disease activity is defined as a reduction in SLEDAI-2K score of greater than or equal to 4. A decreased score, i.e., a negative change, indicates an improvement in systemic lupus erythematosus disease activity from baseline to Month 6.
Time Frame
Baseline (Day 1) and Month 6
Secondary Outcome Measure Information:
Title
Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 6 as Compared to Baseline
Description
A responder could only be assessed if the full information of all body systems was available. A participant was defined as a responder based on the Systemic Lupus Erythematosus Responder Index 4 (SRI-4) was a composite, binary endpoint based on three variables: mSLEDAI-2K score had to have a reduction from baseline greater than or equal to 4, Physician Global Assessment (PGA) had to have an increase from baseline less than or equal to 0.3. The PGA is a 100 mm visual analog scale used by the physician to assess disease activity ranging for 0 to 3. The scale is anchored with values from 0 = "none" and 3 = "severe"), and BILAG-2004 (no new BILAG A organ domain score and at most one new BILAG B organ domain score) compared with baseline. If one of the SRI-4 mSLEDAI-2K, PGA and BILAG variables were not met the subject was scored a non-responder. Participants that did not fit at least one of the above criteria were assigned to the missing group.
Time Frame
Baseline (Day 1) and Month 6
Title
British Isles Lupus Assessment Group-2004 (BILAG) Disease Activity Index Response at Month 6
Description
The British Isles Lupus Assessment Group-2004 (BILAG) is a comprehensive tool used by the physician to assess disease activity and is sensitive to small changes over time. Response (no worsening) at Month 6 on BILAG-2004 disease activity index was defined as no new BILAG A organ domain score and no more than one new BILAG B organ domain score compared with baseline. No analysis is reported because the model did not meet the convergence criteria.
Time Frame
Baseline (Day 1) and Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed Informed Consent Form prior to any study-mandated procedure Diagnosis of SLE made at least 6 months prior to Screening, by fulfilling at least 4 of the 11 criteria for SLE as defined by the American College of Rheumatology (ACR) criteria A mSLEDAI-2K score ≥ 6 of at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers). Currently treated with stable doses of one or more of the following background medications: NSAIDs Anti-malarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine) Mycophenolate mofetil (≤ 2 g/day) Mycophenolic acid (≤ 1440 mg/day) Azathioprine (≤ 2 mg/kg/day) Methotrexate (≤ 20 mg/week) Corticosteroids (≤ 40 mg/day prednisone or equivalent) Belimumab (≤10 mg/kg every 4 weeks intravenously, or 200 mg/week subcutaneously). History or presence of positive autoantibodies measured by central laboratory defined as follows: (a) Positive antinuclear antibody (ANA) test measured by immunofluorescence assay (IFA) with titre ≥1:80; AND/OR (b) positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies with titre ≥30 IU/mL Women of childbearing potential: Must have a negative serum pregnancy test at Screening Must agree to undertake monthly urine pregnancy tests during the study Must use highly effective methods of contraception from the screening visit until 6 months after taking the last dose of study treatment. Exclusion Criteria: Active lupus nephritis or a renal biopsy demonstrating immune complex mediated glomerulonephritis compatible with lupus nephritis. CNS (Central Nervous System) lupus and severe forms of vasculitis requiring systemic immunosuppressive treatment A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with rheumatoid arthritis, erosive arthritis, scleroderma or autoimmune hepatitis History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia or syncope associated with cardiac disorders Subjects who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure defined by the New York Heart Association Class III/IV within six months prior to Screening An elevated QT corrected for HR (Heart Rate) on the basis of Fridericia's formula interval of > 470 ms (females) / > 450 ms (males) History or presence of severe respiratory disease or pulmonary fibrosis Active or latent tuberculosis Ongoing bacterial, viral or fungal infection that is of clinical concern in the judgment of the investigator or history of any serious infection Subjects who have congenital or acquired severe immunodeficiency or known HIV infection or positive HIV testing Presence of macular edema or active uveitis Type 1 or 2 diabetes that is poorly controlled according to investigator judgment, or diabetes complicated with organ involvement such as diabetic nephropathy or retinopathy Significant hematology abnormality: Lymphocyte count < 800 /μL (0.8 × 10e9/L); hemoglobin < 9 g/dL; WBC (White Blood Cell) count < 2500/μL (2.5 × 10e9/L) or platelets < 75000/μL (75 × 10e9/L) Estimated glomerular filtration rate < 60 mL/min/1.73 m2 Known allergy to S1P (sphingosine-1-phosphate) receptor modulators or any of the cenerimod formulation excipients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ClinicalTrials
Organizational Affiliation
Idorsia Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0493
Country
United States
Facility Name
Valerius Medical Group and Research Center
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-5403
Country
United States
Facility Name
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Robert W Levin MD PA
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Center for Rheumatology Immunology and Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Life Clinical Trials
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
San Marcus Research Clinic
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
D&H National Research Centers INC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174-1139
Country
United States
Facility Name
Integral Rheumatology & Immunology Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Advanced Research Institute Inc Allergy & Rheumatology
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33708
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
North Georgia Rheumatology Group - Duluth
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Institute of Arthritis Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Innovative Health Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
New York Presbyterian Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
State University of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Joint Muscle Medical Care and Research Institute - Lilington Office
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
DJL Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Paramount Medical Research and Consulting
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Office of Ramesh C. Gupta, MD
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Amarillo Center for Clinical Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Southwest Rheumatology Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Accurate Clinical Management
City
Stafford
State/Province
Texas
ZIP/Postal Code
77477
Country
United States
Facility Name
Multiprofile Hospital For Active Treatment Trimontium
City
Plovdiv
State/Province
Plodiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Pulmed
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Diagnostic and Consulting Center "Aleksandrovska" EOOD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Diagnostic Consulting Center Fokus-5
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Facility Name
Enroll SpA
City
Santiago
ZIP/Postal Code
7500588
Country
Chile
Facility Name
Biomedica Research Group
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Meditek Ltda.
City
Santiago
ZIP/Postal Code
8330008
Country
Chile
Facility Name
Prosalud
City
Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Clinical Research Chile SpA
City
Valdivia
ZIP/Postal Code
5110683
Country
Chile
Facility Name
CCR Pardubice
City
Pardubice
State/Province
Vychodocesky KRAJ
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Centre Hospitalier Regional Universitaire Brest Hôpital de la Cavale Blanche à Brest
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29609
Country
France
Facility Name
Hôpital Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
LTD "New Plasma Clinic"
City
Batumi
ZIP/Postal Code
6010
Country
Georgia
Facility Name
Aversi Clinic LTD
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Medi Club Georgia Ltd.
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Ltd. Mtskheta Street Clinic
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
The First Medical Center Ltd.
City
Tbilisi
ZIP/Postal Code
0180
Country
Georgia
Facility Name
LLC "Innova"
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
LLC Raymann
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
LTD "Tbilisi Heart Center"
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Medicore
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Multiprofile Clinic Consilium Medulla
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Städtisches Klinikum Karlsruhe gGmbH
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
General Hospital of Athens "Laiko"
City
Goudí
ZIP/Postal Code
11527
Country
Greece
Facility Name
Egyesitett Szent Istvan es Szent Laszlo Korhaz Rendelointezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Rambam Healthcare Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
LUPUS CLINIC c/o DIMI
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
ZIP/Postal Code
00158
Country
Italy
Facility Name
Fondazione Policlinico Universitario A. Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
A.O. Mauriziano Umberto I di Torino
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
Tomakomai City Hospital
City
Tomakomai-shi
ZIP/Postal Code
053-0034
Country
Japan
Facility Name
Karla Adriana Espinosa Bautista
City
Ciudad de México
ZIP/Postal Code
01120
Country
Mexico
Facility Name
Consultorio Particular Dr. Miguel Cortés Hernández
City
Cuernavaca
ZIP/Postal Code
62448
Country
Mexico
Facility Name
Centro Integral en Reumatología S.A. de C.V.
City
Guadalajara
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Icle S.C.
City
Guadalajara
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Consultorio Privado de Especialidad del Dr. José Javier Orozco Alcalá
City
Guadalajara
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Consultorio Médico del Dr. Federico Galván Villegas
City
Guadalajara
ZIP/Postal Code
45040
Country
Mexico
Facility Name
Morales Vargas Centro de Investigación S.C.
City
León
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Centro de Investigación Clínica GRAMEL, S.C.
City
Mexico City
ZIP/Postal Code
03720
Country
Mexico
Facility Name
Biológicos Especializados S.A. de C.V.
City
Mexico City
ZIP/Postal Code
6700
Country
Mexico
Facility Name
Accelerium, S. de R.L. de C.V.
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
Facility Name
UBAM Unidad Biomédica Avanzada Monterrey
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Unidad de Atención Médica e Investigación en Salud
City
Mérida
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Kohler & Milstein Research S.A. de C.V.
City
Mérida
ZIP/Postal Code
97070
Country
Mexico
Facility Name
SMIQ, S. de R.L. de C.V.
City
Queretaro
ZIP/Postal Code
76070
Country
Mexico
Facility Name
Hospital Universitario "Dr. Gonzalo Valdés Valdés"
City
Saltillo
ZIP/Postal Code
25000
Country
Mexico
Facility Name
Unidad de Investigaciones Reumatológicas A.C.
City
San Luis Potosí
ZIP/Postal Code
78290
Country
Mexico
Facility Name
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
City
San Luis Potosí
Country
Mexico
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
City
Zapopan
ZIP/Postal Code
45030
Country
Mexico
Facility Name
Lipa Medix Medical Center
City
Lipa City
State/Province
Batangas
ZIP/Postal Code
4217
Country
Philippines
Facility Name
Angeles University Foundation Medical Center
City
Angeles City
Country
Philippines
Facility Name
Davao Doctors Hospital
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Iloilo Doctors Hospital
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Makati Medical Center
City
Makati City
ZIP/Postal Code
1229
Country
Philippines
Facility Name
University of the Philippines Manila - Philippine General Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Jose R. Reyes Memorial Medical Center
City
Manila
ZIP/Postal Code
1003
Country
Philippines
Facility Name
University of Santo Tomas Hospital
City
Manila
ZIP/Postal Code
1015
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Far Eastern University - Nicanor Reyes Medical Foundation
City
Quezon City
ZIP/Postal Code
1118
Country
Philippines
Facility Name
Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Intermedius Uslugi Medyczne
City
Koscian
ZIP/Postal Code
64-000
Country
Poland
Facility Name
Szpital Specjalistyczny im. J. Dietla w Krakowie
City
Krakow
ZIP/Postal Code
30-121
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Kraków
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Twoja Przychodnia Poznańskie Centrum Medyczne
City
Poznań
ZIP/Postal Code
61-293
Country
Poland
Facility Name
Śląskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepełnosprawności im gen. Jerzego Zi
City
Ustroń
ZIP/Postal Code
43-450
Country
Poland
Facility Name
Centro Reumatologico de Caguas
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Spitalul Clinic "Sf. Maria"
City
Bucharest
ZIP/Postal Code
11172
Country
Romania
Facility Name
SC Sana Monitoring SRL
City
Bucuresti
ZIP/Postal Code
11025
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Chelyabinsk Regional Clinical Hospital
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
JSC "Center of Family Medicine"
City
Ekaterinburg
ZIP/Postal Code
620043
Country
Russian Federation
Facility Name
City Clinical Hospital #15 named after O.M. Filatova
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Federal State Budget Scientific Research Institution "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Non-governmental private healthcare organization, Scientific Clinical Centre of JSC Russian Railways
City
Moscow
ZIP/Postal Code
125315
Country
Russian Federation
Facility Name
Medical Center "Zdorovaya Semiya", LLC
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Orenburg State Medical University
City
Orenburg
ZIP/Postal Code
460018
Country
Russian Federation
Facility Name
Clinical Rheumatological Hospital Number 25
City
Saint Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Polyclinic of Private Security and Detectives
City
Saint Petersburg
ZIP/Postal Code
192007
Country
Russian Federation
Facility Name
Medical Research Institute, LLC
City
Saint Petersburg
ZIP/Postal Code
196006
Country
Russian Federation
Facility Name
Medical Center Maksimum Zdorovia
City
Saint Petersburg
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Military Medical Academy S.M. Kirov
City
Saint-Petersburg
ZIP/Postal Code
191045
Country
Russian Federation
Facility Name
Saratov Regional Clinical Hospital
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
State Institution of Health Protection "Clinical Hospital #8"
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
Hospital Universitario Regional de Málaga
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Quirónsalud Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Songklanagarind Hospital
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Facility Name
Kyiv City Clinical Hospital №3
City
Kyiv
ZIP/Postal Code
02125
Country
Ukraine
Facility Name
Clinic of State Institution "National Scientific Centre "Acad. Strazhesko Institute of Cardiology"
City
Kyiv
ZIP/Postal Code
03151
Country
Ukraine
Facility Name
Medical Centre "Consilium medical"
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Municipal Institution Kyiv Regional Council "Kyiv Regional Clinical Hospital"
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Municipal Nonprofit Institution of Lviv Regional Council "Lviv Regional Clinical Hospital"
City
Lviv
ZIP/Postal Code
79000
Country
Ukraine
Facility Name
Municipal Nonprofit Institution of Lviv Regional Council
City
Lviv
ZIP/Postal Code
79000
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Poltava Regional Clinical Hospital named after M.V. Sklifossovsky
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Ternopil University Clinic - Rheumatology department
City
Ternopil
ZIP/Postal Code
46001
Country
Ukraine
Facility Name
Zakarpattya Regional Clinical Hospital n.a. A.Novak - Rheumatology Department
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Private Small Scale Medical Center "Pulse"
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
Medical Center "Health Clinic", LLC
City
Vinnytsia
ZIP/Postal Code
21009
Country
Ukraine
Facility Name
Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital №1"
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Scientific and Research Institute of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU,
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Vinnytsya Regional Clinical Hospital - Rheumatology Department
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Municipal Institution "Zaporizhzhya Regional Clinical Hospital"
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Municipal institution "Regional Clinical Hospital n.a. O.F. Herbachevskoho"
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Guy's and Saint Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

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