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A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus

Primary Purpose

Lupus Erythematosus, Systemic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CC-220
Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring CC-220, Safety, Efficacy, Active Systemic Lupus Erythematosus

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female 18 years of age or older at the time of signing the informed consent.
  • Have a diagnosis of SLE for at least 6 months prior to the Screening Visit and fulfill the 1997 update of the 1982 American College of Rheumatology (ACR) Classification Criteria for SLE at the Screening Visit.
  • A SLEDAI 2K score of ≥ 6 points, WITH at least 4 points being a "clinical" SLEDAI 2K score. The "clinical" score excludes points attributable to any urine or blood laboratory results including immunologic measures.
  • At the Baseline Visit, a clinical SLEDAI 2K score of ≥ 4 points.

  • Have at least one of the following positive antibodies associated with SLE per the central laboratory within the Screening Phase:

    • Positive antinuclear antibody (ANA) test at the central laboratory with a titer of 1:40 or greater, associated with a diagnosis of SLE,
    • Anti-dsDNA antibodies elevated to above normal
    • Anti-Smith (anti-Sm) antibody elevated to above normal

  • Females of childbearing potential must: Have two negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment.

    o Either commit to true abstinence from heterosexual contact or agree to use two forms of reliable contraception simultaneously.

  • Male subjects must: Practice true abstinence or agree to use a barrier contraception during sexual contact.

All subjects must:

  • Understand that the IP could have potential teratogenic risk.

  • Agree to abstain from donating blood while taking IP and for 28 days following discontinuation of the IP.

    • Have been treated with at least one of the following SLE medications prior to the Screening Visit: antimalarials, immunosuppressants, and/or corticosteroids.
    • Currently receiving stable doses of at least one of the following medications: systemic corticosteroids, antimalarials, and/or immunosuppressants.

Exclusion Criteria:

  • Received intra-articular, intralesional, subcutaneous, intradermal, intramuscular or IV pulse corticosteroids 6 weeks prior to the Baseline Visit.
  • Received any other biologic or non-biologic immunosuppressive agent within 2 months of 5 pharmacokinetic half-lives (whichever is longer) prior to the Baseline Visit.
  • Have severe lupus nephritis defined as: estimated glomerular filtration rate of < 45 mL/1.73 m2 or proteinuria > 2000 mg/day based on protein to creatinine ratio, or active lupus nephritis that may require 'induction' therapy
  • Have active, severe or unstable neuropsychiatric lupus disease within 6 months of the Screening Visit.
  • Have serologic tests consistent with infection with either hepatitis B or hepatitis C, and/or confirmed history of hepatitis B or hepatitis C infection.
  • Have history of congenital and/or acquired immunodeficiencies (eg, common variable immunodeficiency, human immunodeficiency virus, etc).
  • Have active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, or any major episode of infection requiring hospitalization or treatment with intravenous or oral antibiotics within 4 weeks of the Screening Visit and at any time during the Screening Phase, up through the first dose of IP.
  • Have active tuberculosis or a history of latent or active tuberculosis

  • Have malignancy or history of malignancy, except for:

    • treated (eg, cured) basal cell or squamous cell in situ skin carcinomas
    • treated (eg, cured) cervical intraepithelial neoplasia Grade 1 and Grade 2
    • treated (eg, cured) carcinoma in situ of the cervix with no evidence of recurrence within 5 years of the Screening Visit.
  • Have a diagnosis or history consistent with Antiphospholipid Syndrome or "triple antiphospholipid positivity" (ie, positive lupus anticoagulant, anticardiolipin, and anti-B2 glycoprotein).
  • Have history of arterial or venous thrombosis
  • Have history or current diagnosis of peripheral neuropathy (sensory or motor) ≥ Grade 2.
  • Have presence of active uveitis or any other ophthalmological finding that in the opinion of the Investigator is clinically significant.
  • Have other non-SLE driven inflammatory joint or skin disease or overlap syndromes as the primary disease.
  • Have clinically significant or unstable or uncontrolled acute or chronic disease not due to SLE
  • Does not meet required laboratory criteria.
  • Does not meet pre-specified periods for prohibited medications.
  • Pregnant or a breast-feeding female.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Sites / Locations

  • Clinical and Translational Research Center of Alabama, PC
  • AZ Arthritis and Rheum Rsch, PLLC
  • Saint Jude Heritage Medical Center
  • University of California San Diego Medical Center
  • UCLA Division of Rheumatology
  • Desert Medical Advances
  • C Michael Neuwelt M D
  • Inland Rheumatology Clinical Trials
  • University of Colorado Denver
  • Yale University School of Medicine
  • Centre For Rheumatology, Immun. And Arthritis
  • University of Florida College of Medicine
  • University of Miami
  • Integral Rheumatology and Immunology Specialists
  • Bay Care Medical Group
  • Emory University School of Medicine
  • Piedmont Hospital - Atlanta
  • Jefrey Lieberman, MD, PC
  • North Georgia Rheumatology
  • Clinic of Robert Hozman
  • University of Maryland - School of Medicine
  • Beth Israel Deaconness Medical Center
  • Advanced Rheumatology
  • Great Lakes Center of Rheumatology
  • Arthritis and Osteoporosis Associates of New Mexico
  • Montefiore Medical Center
  • Local Institution - 134
  • North Shore-LIJ Health System-Division of Rheumatology
  • NYU Langone Medical Center
  • Local Institution - 124
  • SUNY Upstate Medical University
  • DJL Clinical Research
  • Local Institution - 101
  • Shanahan Rheumatology and Immunotherapy
  • MetroHealth Medical Systems
  • St. Anthony's Medical Center
  • Hershey Medical Center
  • Local Institution - 136
  • University of Pennsylvania Department of Dermatology
  • University Of Pennsylvania
  • University of Pittsburgh UPMC Lupus Center of Excellence
  • Advanced Rheumatology & Arthritis Research Center, PC
  • Medical University of South Carolina
  • UT Southwestern Medical Center
  • Pioneer Research Solutions
  • Virginia Mason Medical Center
  • Local Institution - 628
  • Organización Médica de Investigación
  • Hospital General de Agudos Dr. Jose Maria Ramos Mejia
  • Local Institution - 625
  • Hospital Britanico de Buenos Aires
  • Consultora Integral de Salud Centro Médico Privado
  • Local Institution - 626
  • Hospital Privado Centro Medico de Cordoba
  • CER Instituto Mèdico
  • Local Institution - 630
  • Instituto de Investigaciones Clinicas de Quilmes
  • Local Institution - 629
  • Centro Medico Privado de Reumatologia
  • Local Institution - 627
  • Hopital Erasme
  • Local Institution - 425
  • Local Institution - 427
  • Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
  • CHU de Liege
  • Local Institution - 426
  • Centro Internacional de Pesquisas
  • Local Institution - 655
  • Centro de Estudos em Terapias Inovadoras LTDA
  • Local Institution - 653
  • LMK Servicos Medicos S/S
  • Local Institution - 650
  • Local Institution - 657
  • State University of Campinas UNICAMP
  • Local Institution - 652
  • Santa Casa de Misericórdia de Belo Horizonte
  • Hospital de Clinicas de Porto Alegre
  • Centro de Imunoterapia de Ipanema (CITIPA)
  • Local Institution - 651
  • Local Institution - 205
  • The University of Calgary
  • Local Institution - 204
  • University of Manitoba
  • Local Institution - 201
  • MAC Research Incorporated
  • Local Institution - 202
  • Toronto Western Hospital
  • CHUL du CHU de Quebec
  • Local Institution - 203
  • Clinique de Rhumatologie Du Centre Du Quebec
  • Local Institution - 200
  • IPS Centro Integral de Reumatologia del Caribe Circaribe S.A.S.
  • Local Institution - 675
  • Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S. - Cireem S.A.S
  • Local Institution - 682
  • Idearg S.A.S.
  • Local Institution - 676
  • Local Institution - 679
  • Medicity S.A.S.
  • Servimed S.A.S.
  • Local Institution - 677
  • Preventive Care
  • Local Institution - 678
  • Reumalab - Centro Integral de Reumatologia
  • Hospital Pablo Tobon Uribe
  • Local Institution - 680
  • CHRU de Lille France
  • Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere
  • Local Institution - 326
  • CHU Hautepierre
  • Local Institution - 302
  • Universitatsklinikum Schleswig-Holstein
  • Local Institution - 300
  • Universitaetsklinikum Koeln
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Local Institution - 352
  • Qualiclinic kft
  • Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet
  • Local Institution - 350
  • Bekes Megyei Kozponti Korhaz
  • Local Institution - 351
  • ASST Spedali Civili P.O. di Brescia
  • University of Ferrara, Azienda Ospedaliera-Universitaria S.Anna
  • Azienda Ospedaliero - Universitaria di Cagliari
  • Centro de Investigacion en Artritis y Osteoporosis
  • Local Institution - 610
  • Biológicos Especializados S.A. de C.V.
  • Local Institution - 602
  • Clinica Integral de Osteoporosis y Artitis Reumatoide CLINOSAR
  • Local Institution - 608
  • Centro de Investigación y Tratamiento Reumatológico
  • Local Institution - 607
  • Centro Integral en Reumatología, S.A. de C.V.
  • Local Institution - 600
  • Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.
  • Local Institution - 603
  • Local Institution - 605
  • Unidad de Atencion Medica e Investigacion en Salud, S.C.
  • Hospital Angeles Lindavista
  • Local Institution - 606
  • Local Institution - 380
  • Local Institution - 377
  • Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
  • Local Institution - 376
  • Samodzielny Publiczny Zespól Opieki Zdrowotnej w Koscianie Szpital im. Teodora Dunina
  • Centrum Medyczne Plejady
  • Local Institution - 375
  • Local Institution - 378
  • Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Reumatologii i Ukladowych Chorob Tkanki Laczne
  • Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
  • City Clinical Hospital
  • Local Institution - 506
  • Kemerovo State Medical Academy
  • Local Institution - 505
  • Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru
  • Local Institution - 507
  • Local Institution - 500
  • Orenburg State Medical Academy
  • Saint Petersburg Research Institute for Emergency Medical Care
  • Leningrad Regional Clinical Hospital
  • Local Institution - 502
  • Local Institution - 503
  • State Higher Educational Institution
  • BioMed, LLC.
  • Local Institution - 504
  • Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy
  • Institute of Rheumatology Belgrade
  • Local Institution - 475
  • Local Institution - 476
  • Local Institution - 477
  • Local Institution - 478
  • Military Medical Academy
  • Clinical Center Kragujevac
  • Local Institution - 480
  • Institute Niska Banja
  • Local Institution - 479
  • Hospital Universitario a Coruna
  • Local Institution - 400
  • Hospital Universitario Vall D hebron
  • Local Institution - 403
  • Hospital Universitario de Canarias
  • Hospital Marques de Valdecilla
  • Local Institution - 405
  • Hospital Universitario Araba - Txagorritxu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

CC-220 0.45 mg QD Placebo Controlled Phase

C-220 0.3 mg QD Placebo Controlled Phase

CC-220 0.15 mg QD Placebo Controlled Phase

Placebo

Arm Description

At Weeks 0 to 24: CC-220 Placebo Controlled Phase: CC-220 0.45 mg once daily (QD) At Weeks 24 to 52: CC-220 Active Treatment Phase: CC-220 0.45 mg once daily (QD) Long-term Extension Phase (52 weeks to 104 weeks): At Week 52 all subjects who elect to continue in the Long-term Extension will stay on the same dose they were on at the conclusion of the randomized, double-blind, active treatment phase.

At Weeks 0 to 24: CC-220 Placebo Controlled Phase: CC-220 0.3 mg once daily (QD) At Weeks 24 to 52: CC-220 Active Treatment Phase: CC-220 0.30 mg once daily (QD) Long-term Extension Phase (52 weeks to 104 weeks): At Week 52 all subjects who elect to continue in the Long-term Extension will stay on the same dose they were on at the conclusion of the randomized, double-blind, active treatment phase.

At Weeks 0 to 24: CC-220 Placebo Controlled Phase: CC-220 0.15 mg once daily (QD) At Weeks 24 to 52: CC-220 Active Treatment Phase: CC-220 0.15 mg once daily (QD) Long-term Extension Phase (52 weeks to 104 weeks): At Week 52 all subjects who elect to continue in the Long-term Extension will stay on the same dose they were on at the conclusion of the randomized, double-blind, active treatment phase.

Weeks 0 to 24: CC-220 Placebo Controlled Phase: placebo once daily (QD)

Outcomes

Primary Outcome Measures

Number of Participants Who Achieve SLE Responder Index (SRI) (4) Response
The primary objective is to evaluate the clinical efficacy of three doses of CC-220 (0.45 mg once per day [QD], 0.3 mg QD or 0.15 mg QD) compared to placebo, for the treatment of active systemic lupus erythematosus (SLE) using the SLE Responder Index at Week 24 Composite endpoint SRI(4), defined by the following criteria: - Reduction from Baseline of ≥ 4 points in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K score and - No new one or more British Isles Lupus Assessment Group (BILAG) A or new (excludes A to B) 2 or more BILAG B items compared to Baseline using BILAG 2004 Index and - No worsening from Baseline defined by an increase of < 0.30 points from Baseline on a Physician's Global Assessment (PGA) visual analog scale (VAS) from 0-3

Secondary Outcome Measures

Number of Participants With SLEDAI 2K Score Improvement of ≥ 4 Points From Baseline
The SLEDAI 2K score measures disease activity through assessment of 24 lupus manifestations using a weighted score of 1 to 8 points. A manifestation is recorded if it is present over the previous 30 days regardless of severity or whether it has improved or worsened. A SLEDAI 2K score of 3 to 4 points is representative of active disease and a decrease of 1 to 2 points is considered clinically meaningful.
Number of Participants With a ≥ 50% Reduction in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score From Baseline, in Participants With Baseline CLASI Activity Score ≥ 10
The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and non-scarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together.
Number of Participants With no New Organ System Affected as Defined by 1 or More BILAG A or New (Excludes A to B) 2 or More BILAG B Items Compared to Baseline Using BILAG 2004 Index
The BILAG 2004 is a composite index that is based on the Classic BILAG index. It is a clinical measure of lupus disease activity. This tool assesses the changing severity of clinical manifestations of SLE using an ordinal scale scoring system that contain 9 systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and hematological). Activity in each organ system is scored as: A=most active disease; B=intermediate activity; C=mild, stable disease; D=previous involvement, currently inactive; E=no previous activity.
Percentage of Participants With no Worsening (Increase of < 0.30 Points From Baseline) in PGA Compared to Baseline
The PGA uses a visual analog scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none, 1 = mild disease, 2 = moderate disease, and 3 = severe disease.
Mean Change From Baseline in Swollen Joint Count in Participants With ≥ 2 Swollen Joints at Baseline
Joint tenderness and swelling will be noted as "present" or "absent," with no quantitation of severity using a 28- joint count. Note: Data presented is Adjusted mean data.
Mean Change From Baseline in Tender Joint Count in Participants With ≥ 2 Tender Joints at Baseline
Joint tenderness and swelling will be noted as "present" or "absent," with no quantitation of severity using a 28- joint count. Note: Data presented is Adjusted mean data.
Mean Change From Baseline in PGA Score
The PGA uses a visual analog scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none, 1 = mild disease, 2 = moderate disease, and 3 = severe disease.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total FACIT-Fatigue score ranges from 0 to 52. Note: Data presented is Adjusted mean data.
Percentage of Participants With Corticosteroid Reduction
- The percentage of participants with a prednisone or equivalent dose of ≥ 10 mg/day at Baseline whose prednisone or equivalent dose has been reduced to ≤ 7.5 mg/day by Week 16 and maintained through Week 24 with no flares between Week 16 and Week 24 - The percentage of participants with a prednisone or equivalent dose of ≥ 10 mg/day at Baseline whose prednisone or equivalent dose has been reduced to < 10 mg/day by Week 16 and maintained through Week 24 with no flares between Week 16 and Week 24
Percent Change From Baseline in Corticosteroid Reduction
Percent change from Baseline in oral corticosteroid (OCS) dose in subjects with prednisone or equivalent ≥ 10 mg/day at Baseline Note: Data presented is Adjusted mean data.
The Total Corticosteroid Dose From Baseline Through Week 24
Standardized total oral corticosteroid (OCS) dose.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number of participants who experienced a TEAE during the course of the study

Full Information

First Posted
May 18, 2017
Last Updated
June 13, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT03161483
Brief Title
A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus
Official Title
A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
August 3, 2021 (Actual)
Study Completion Date
August 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

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 this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus. Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.
Detailed Description
The study consists of four phases: 4-week Screening Phase 24-week placebo-controlled phase Subjects will receive either 0.45 mg QD, 0.3 mg QD, 0.15 mg QD or placebo for the first 24 weeks of treatment. 28-week active treatment phase At Week 24, all subjects on placebo will be re-randomized to active treatment. 52-week long-term extension phase Subjects who complete the treatment phase may be eligible to roll over into a Long-term Extension of up to 52 weeks of treatment. 4 - 12-week observational follow-up All subjects who complete 52 weeks of treatment or discontinue the study early will enter a post-treatment observation follow-up phase. The Observational Follow-up Phase will consist of one visit 4 weeks following cessation of study drug for all subjects with an additional 12-week Observational Follow-up visit for males only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
CC-220, Safety, Efficacy, Active Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
289 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CC-220 0.45 mg QD Placebo Controlled Phase
Arm Type
Experimental
Arm Description
At Weeks 0 to 24: CC-220 Placebo Controlled Phase: CC-220 0.45 mg once daily (QD) At Weeks 24 to 52: CC-220 Active Treatment Phase: CC-220 0.45 mg once daily (QD) Long-term Extension Phase (52 weeks to 104 weeks): At Week 52 all subjects who elect to continue in the Long-term Extension will stay on the same dose they were on at the conclusion of the randomized, double-blind, active treatment phase.
Arm Title
C-220 0.3 mg QD Placebo Controlled Phase
Arm Type
Experimental
Arm Description
At Weeks 0 to 24: CC-220 Placebo Controlled Phase: CC-220 0.3 mg once daily (QD) At Weeks 24 to 52: CC-220 Active Treatment Phase: CC-220 0.30 mg once daily (QD) Long-term Extension Phase (52 weeks to 104 weeks): At Week 52 all subjects who elect to continue in the Long-term Extension will stay on the same dose they were on at the conclusion of the randomized, double-blind, active treatment phase.
Arm Title
CC-220 0.15 mg QD Placebo Controlled Phase
Arm Type
Experimental
Arm Description
At Weeks 0 to 24: CC-220 Placebo Controlled Phase: CC-220 0.15 mg once daily (QD) At Weeks 24 to 52: CC-220 Active Treatment Phase: CC-220 0.15 mg once daily (QD) Long-term Extension Phase (52 weeks to 104 weeks): At Week 52 all subjects who elect to continue in the Long-term Extension will stay on the same dose they were on at the conclusion of the randomized, double-blind, active treatment phase.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Weeks 0 to 24: CC-220 Placebo Controlled Phase: placebo once daily (QD)
Intervention Type
Drug
Intervention Name(s)
CC-220
Intervention Description
CC-220
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo QD PO
Primary Outcome Measure Information:
Title
Number of Participants Who Achieve SLE Responder Index (SRI) (4) Response
Description
The primary objective is to evaluate the clinical efficacy of three doses of CC-220 (0.45 mg once per day [QD], 0.3 mg QD or 0.15 mg QD) compared to placebo, for the treatment of active systemic lupus erythematosus (SLE) using the SLE Responder Index at Week 24 Composite endpoint SRI(4), defined by the following criteria: - Reduction from Baseline of ≥ 4 points in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K score and - No new one or more British Isles Lupus Assessment Group (BILAG) A or new (excludes A to B) 2 or more BILAG B items compared to Baseline using BILAG 2004 Index and - No worsening from Baseline defined by an increase of < 0.30 points from Baseline on a Physician's Global Assessment (PGA) visual analog scale (VAS) from 0-3
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Number of Participants With SLEDAI 2K Score Improvement of ≥ 4 Points From Baseline
Description
The SLEDAI 2K score measures disease activity through assessment of 24 lupus manifestations using a weighted score of 1 to 8 points. A manifestation is recorded if it is present over the previous 30 days regardless of severity or whether it has improved or worsened. A SLEDAI 2K score of 3 to 4 points is representative of active disease and a decrease of 1 to 2 points is considered clinically meaningful.
Time Frame
Week 24
Title
Number of Participants With a ≥ 50% Reduction in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score From Baseline, in Participants With Baseline CLASI Activity Score ≥ 10
Description
The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and non-scarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together.
Time Frame
Week 24
Title
Number of Participants With no New Organ System Affected as Defined by 1 or More BILAG A or New (Excludes A to B) 2 or More BILAG B Items Compared to Baseline Using BILAG 2004 Index
Description
The BILAG 2004 is a composite index that is based on the Classic BILAG index. It is a clinical measure of lupus disease activity. This tool assesses the changing severity of clinical manifestations of SLE using an ordinal scale scoring system that contain 9 systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and hematological). Activity in each organ system is scored as: A=most active disease; B=intermediate activity; C=mild, stable disease; D=previous involvement, currently inactive; E=no previous activity.
Time Frame
Week 24
Title
Percentage of Participants With no Worsening (Increase of < 0.30 Points From Baseline) in PGA Compared to Baseline
Description
The PGA uses a visual analog scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none, 1 = mild disease, 2 = moderate disease, and 3 = severe disease.
Time Frame
Week 24
Title
Mean Change From Baseline in Swollen Joint Count in Participants With ≥ 2 Swollen Joints at Baseline
Description
Joint tenderness and swelling will be noted as "present" or "absent," with no quantitation of severity using a 28- joint count. Note: Data presented is Adjusted mean data.
Time Frame
Week 24
Title
Mean Change From Baseline in Tender Joint Count in Participants With ≥ 2 Tender Joints at Baseline
Description
Joint tenderness and swelling will be noted as "present" or "absent," with no quantitation of severity using a 28- joint count. Note: Data presented is Adjusted mean data.
Time Frame
Week 24
Title
Mean Change From Baseline in PGA Score
Description
The PGA uses a visual analog scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none, 1 = mild disease, 2 = moderate disease, and 3 = severe disease.
Time Frame
Week 24
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
Description
The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total FACIT-Fatigue score ranges from 0 to 52. Note: Data presented is Adjusted mean data.
Time Frame
Week 24
Title
Percentage of Participants With Corticosteroid Reduction
Description
- The percentage of participants with a prednisone or equivalent dose of ≥ 10 mg/day at Baseline whose prednisone or equivalent dose has been reduced to ≤ 7.5 mg/day by Week 16 and maintained through Week 24 with no flares between Week 16 and Week 24 - The percentage of participants with a prednisone or equivalent dose of ≥ 10 mg/day at Baseline whose prednisone or equivalent dose has been reduced to < 10 mg/day by Week 16 and maintained through Week 24 with no flares between Week 16 and Week 24
Time Frame
Week 24
Title
Percent Change From Baseline in Corticosteroid Reduction
Description
Percent change from Baseline in oral corticosteroid (OCS) dose in subjects with prednisone or equivalent ≥ 10 mg/day at Baseline Note: Data presented is Adjusted mean data.
Time Frame
Week 24
Title
The Total Corticosteroid Dose From Baseline Through Week 24
Description
Standardized total oral corticosteroid (OCS) dose.
Time Frame
Through Week 24
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
Number of participants who experienced a TEAE during the course of the study
Time Frame
from first dose to 28 days post-last dose through Week 24 (placebo-controlled phase), approximately 28 weeks total

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female 18 years of age or older at the time of signing the informed consent. Have a diagnosis of SLE for at least 6 months prior to the Screening Visit and fulfill the 1997 update of the 1982 American College of Rheumatology (ACR) Classification Criteria for SLE at the Screening Visit. A SLEDAI 2K score of ≥ 6 points, WITH at least 4 points being a "clinical" SLEDAI 2K score. The "clinical" score excludes points attributable to any urine or blood laboratory results including immunologic measures. At the Baseline Visit, a clinical SLEDAI 2K score of ≥ 4 points. Have at least one of the following positive antibodies associated with SLE per the central laboratory within the Screening Phase: Positive antinuclear antibody (ANA) test at the central laboratory with a titer of 1:40 or greater, associated with a diagnosis of SLE, Anti-dsDNA antibodies elevated to above normal Anti-Smith (anti-Sm) antibody elevated to above normal Females of childbearing potential must: Have two negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. o Either commit to true abstinence from heterosexual contact or agree to use two forms of reliable contraception simultaneously. Male subjects must: Practice true abstinence or agree to use a barrier contraception during sexual contact. All subjects must: Understand that the IP could have potential teratogenic risk. Agree to abstain from donating blood while taking IP and for 28 days following discontinuation of the IP. Have been treated with at least one of the following SLE medications prior to the Screening Visit: antimalarials, immunosuppressants, and/or corticosteroids. Currently receiving stable doses of at least one of the following medications: systemic corticosteroids, antimalarials, and/or immunosuppressants. Exclusion Criteria: Received intra-articular, intralesional, subcutaneous, intradermal, intramuscular or IV pulse corticosteroids 6 weeks prior to the Baseline Visit. Received any other biologic or non-biologic immunosuppressive agent within 2 months of 5 pharmacokinetic half-lives (whichever is longer) prior to the Baseline Visit. Have severe lupus nephritis defined as: estimated glomerular filtration rate of < 45 mL/1.73 m2 or proteinuria > 2000 mg/day based on protein to creatinine ratio, or active lupus nephritis that may require 'induction' therapy Have active, severe or unstable neuropsychiatric lupus disease within 6 months of the Screening Visit. Have serologic tests consistent with infection with either hepatitis B or hepatitis C, and/or confirmed history of hepatitis B or hepatitis C infection. Have history of congenital and/or acquired immunodeficiencies (eg, common variable immunodeficiency, human immunodeficiency virus, etc). Have active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, or any major episode of infection requiring hospitalization or treatment with intravenous or oral antibiotics within 4 weeks of the Screening Visit and at any time during the Screening Phase, up through the first dose of IP. Have active tuberculosis or a history of latent or active tuberculosis Have malignancy or history of malignancy, except for: treated (eg, cured) basal cell or squamous cell in situ skin carcinomas treated (eg, cured) cervical intraepithelial neoplasia Grade 1 and Grade 2 treated (eg, cured) carcinoma in situ of the cervix with no evidence of recurrence within 5 years of the Screening Visit. Have a diagnosis or history consistent with Antiphospholipid Syndrome or "triple antiphospholipid positivity" (ie, positive lupus anticoagulant, anticardiolipin, and anti-B2 glycoprotein). Have history of arterial or venous thrombosis Have history or current diagnosis of peripheral neuropathy (sensory or motor) ≥ Grade 2. Have presence of active uveitis or any other ophthalmological finding that in the opinion of the Investigator is clinically significant. Have other non-SLE driven inflammatory joint or skin disease or overlap syndromes as the primary disease. Have clinically significant or unstable or uncontrolled acute or chronic disease not due to SLE Does not meet required laboratory criteria. Does not meet pre-specified periods for prohibited medications. Pregnant or a breast-feeding female. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nataliya Agafonova, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Clinical and Translational Research Center of Alabama, PC
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
AZ Arthritis and Rheum Rsch, PLLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Saint Jude Heritage Medical Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCLA Division of Rheumatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
C Michael Neuwelt M D
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Inland Rheumatology Clinical Trials
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Centre For Rheumatology, Immun. And Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Integral Rheumatology and Immunology Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Bay Care Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Piedmont Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Jefrey Lieberman, MD, PC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033-5910
Country
United States
Facility Name
North Georgia Rheumatology
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Clinic of Robert Hozman
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
University of Maryland - School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Beth Israel Deaconness Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Advanced Rheumatology
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Great Lakes Center of Rheumatology
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Arthritis and Osteoporosis Associates of New Mexico
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011-4741
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Local Institution - 134
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
North Shore-LIJ Health System-Division of Rheumatology
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 124
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
DJL Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Local Institution - 101
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Shanahan Rheumatology and Immunotherapy
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Facility Name
MetroHealth Medical Systems
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
St. Anthony's Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-8807
Country
United States
Facility Name
Local Institution - 136
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-8807
Country
United States
Facility Name
University of Pennsylvania Department of Dermatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh UPMC Lupus Center of Excellence
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Advanced Rheumatology & Arthritis Research Center, PC
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Pioneer Research Solutions
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Local Institution - 628
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Organización Médica de Investigación
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Hospital General de Agudos Dr. Jose Maria Ramos Mejia
City
Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Local Institution - 625
City
Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Consultora Integral de Salud Centro Médico Privado
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution - 626
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Hospital Privado Centro Medico de Cordoba
City
Cordoba
ZIP/Postal Code
X5016
Country
Argentina
Facility Name
CER Instituto Mèdico
City
Quilmes
ZIP/Postal Code
B1878DVB
Country
Argentina
Facility Name
Local Institution - 630
City
Quilmes
ZIP/Postal Code
B1878DVB
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas de Quilmes
City
Quilmes
ZIP/Postal Code
B1878GEG
Country
Argentina
Facility Name
Local Institution - 629
City
Quilmes
ZIP/Postal Code
B1878GEG
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
San Miguel de Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Local Institution - 627
City
San Miguel de Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Hopital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Local Institution - 425
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Local Institution - 427
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liege
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution - 426
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Centro Internacional de Pesquisas
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Local Institution - 655
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Centro de Estudos em Terapias Inovadoras LTDA
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80030
Country
Brazil
Facility Name
Local Institution - 653
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80030
Country
Brazil
Facility Name
LMK Servicos Medicos S/S
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90480
Country
Brazil
Facility Name
Local Institution - 650
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90480
Country
Brazil
Facility Name
Local Institution - 657
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083-888
Country
Brazil
Facility Name
State University of Campinas UNICAMP
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083-888
Country
Brazil
Facility Name
Local Institution - 652
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Belo Horizonte
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre, RS
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Centro de Imunoterapia de Ipanema (CITIPA)
City
Rio de Janeiro
ZIP/Postal Code
22411-001
Country
Brazil
Facility Name
Local Institution - 651
City
Rio de Janeiro
ZIP/Postal Code
22411-001
Country
Brazil
Facility Name
Local Institution - 205
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
The University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Local Institution - 204
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3Y1X7
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3Y1X7
Country
Canada
Facility Name
Local Institution - 201
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 2B6
Country
Canada
Facility Name
MAC Research Incorporated
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 2B6
Country
Canada
Facility Name
Local Institution - 202
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
CHUL du CHU de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Local Institution - 203
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Clinique de Rhumatologie Du Centre Du Quebec
City
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Local Institution - 200
City
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
IPS Centro Integral de Reumatologia del Caribe Circaribe S.A.S.
City
Barranquilla
ZIP/Postal Code
080002
Country
Colombia
Facility Name
Local Institution - 675
City
Barranquilla
ZIP/Postal Code
080002
Country
Colombia
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S. - Cireem S.A.S
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Local Institution - 682
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Idearg S.A.S.
City
Bogota
ZIP/Postal Code
111211
Country
Colombia
Facility Name
Local Institution - 676
City
Bogota
ZIP/Postal Code
111211
Country
Colombia
Facility Name
Local Institution - 679
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Medicity S.A.S.
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Servimed S.A.S.
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Local Institution - 677
City
Chia
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Preventive Care
City
Chia
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Local Institution - 678
City
Medellin
ZIP/Postal Code
050010
Country
Colombia
Facility Name
Reumalab - Centro Integral de Reumatologia
City
Medellin
ZIP/Postal Code
050010
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Local Institution - 680
City
Medellin
ZIP/Postal Code
050034
Country
Colombia
Facility Name
CHRU de Lille France
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Local Institution - 326
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Local Institution - 302
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution - 300
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsklinikum Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution - 352
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Qualiclinic kft
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Local Institution - 350
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Local Institution - 351
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
ASST Spedali Civili P.O. di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
University of Ferrara, Azienda Ospedaliera-Universitaria S.Anna
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria di Cagliari
City
Monserrato
ZIP/Postal Code
09042
Country
Italy
Facility Name
Centro de Investigacion en Artritis y Osteoporosis
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21200
Country
Mexico
Facility Name
Local Institution - 610
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21200
Country
Mexico
Facility Name
Biológicos Especializados S.A. de C.V.
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Local Institution - 602
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Clinica Integral de Osteoporosis y Artitis Reumatoide CLINOSAR
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Local Institution - 608
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Centro de Investigación y Tratamiento Reumatológico
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Local Institution - 607
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Centro Integral en Reumatología, S.A. de C.V.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Local Institution - 600
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.
City
San Luis Potosi
State/Province
San Luis Potosí
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Local Institution - 603
City
San Luis Potosi
State/Province
San Luis Potosí
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Local Institution - 605
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97130
Country
Mexico
Facility Name
Unidad de Atencion Medica e Investigacion en Salud, S.C.
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97130
Country
Mexico
Facility Name
Hospital Angeles Lindavista
City
D.f, Df
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Local Institution - 606
City
D.f, Df
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Local Institution - 380
City
Wroclaw
State/Province
Woj. Dolnoslaskie
ZIP/Postal Code
53-224
Country
Poland
Facility Name
Local Institution - 377
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Local Institution - 376
City
Koscian
ZIP/Postal Code
64-000
Country
Poland
Facility Name
Samodzielny Publiczny Zespól Opieki Zdrowotnej w Koscianie Szpital im. Teodora Dunina
City
Koscian
ZIP/Postal Code
64-000
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30-349
Country
Poland
Facility Name
Local Institution - 375
City
Krakow
ZIP/Postal Code
30-349
Country
Poland
Facility Name
Local Institution - 378
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Reumatologii i Ukladowych Chorob Tkanki Laczne
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
53-224
Country
Poland
Facility Name
City Clinical Hospital
City
Kazan
ZIP/Postal Code
420103
Country
Russian Federation
Facility Name
Local Institution - 506
City
Kazan
ZIP/Postal Code
420103
Country
Russian Federation
Facility Name
Kemerovo State Medical Academy
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Local Institution - 505
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Local Institution - 507
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Local Institution - 500
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
Orenburg State Medical Academy
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
Saint Petersburg Research Institute for Emergency Medical Care
City
St. Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Local Institution - 502
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Local Institution - 503
City
St. Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
State Higher Educational Institution
City
St. Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
BioMed, LLC.
City
Vladimir
ZIP/Postal Code
600005
Country
Russian Federation
Facility Name
Local Institution - 504
City
Vladimir
ZIP/Postal Code
600005
Country
Russian Federation
Facility Name
Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy
City
Voronezh
ZIP/Postal Code
394066
Country
Russian Federation
Facility Name
Institute of Rheumatology Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Local Institution - 475
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Local Institution - 476
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Local Institution - 477
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Local Institution - 478
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Local Institution - 480
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Institute Niska Banja
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Local Institution - 479
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Hospital Universitario a Coruna
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Local Institution - 400
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Vall D hebron
City
Barcelona
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution - 403
City
Barcelona
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution - 405
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Araba - Txagorritxu
City
Vitoria-Gasteiz
ZIP/Postal Code
01009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28848067
Citation
Nakayama Y, Kosek J, Capone L, Hur EM, Schafer PH, Ringheim GE. Aiolos Overexpression in Systemic Lupus Erythematosus B Cell Subtypes and BAFF-Induced Memory B Cell Differentiation Are Reduced by CC-220 Modulation of Cereblon Activity. J Immunol. 2017 Oct 1;199(7):2388-2407. doi: 10.4049/jimmunol.1601725. Epub 2017 Aug 28.
Results Reference
background
PubMed Identifier
35477518
Citation
Lipsky PE, Vollenhoven RV, Dorner T, Werth VP, Merrill JT, Furie R, Petronijevic M, Velasco Zamora B, Majdan M, Irazoque-Palazuelos F, Terbrueggen R, Delev N, Weiswasser M, Korish S, Stern M, Hersey S, Ye Y, Gaudy A, Liu Z, Gagnon R, Tang S, Schafer PH. Biological impact of iberdomide in patients with active systemic lupus erythematosus. Ann Rheum Dis. 2022 Apr 27;81(8):1136-42. doi: 10.1136/annrheumdis-2022-222212. Online ahead of print.
Results Reference
derived
PubMed Identifier
35294813
Citation
Merrill JT, Werth VP, Furie R, van Vollenhoven R, Dorner T, Petronijevic M, Velasco J, Majdan M, Irazoque-Palazuelos F, Weiswasser M, Korish S, Ye Y, Gaudy A, Schafer PH, Liu Z, Agafonova N, Delev N. Phase 2 Trial of Iberdomide in Systemic Lupus Erythematosus. N Engl J Med. 2022 Mar 17;386(11):1034-1045. doi: 10.1056/NEJMoa2106535.
Results Reference
derived
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://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus

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