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

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

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.

Study Overview

• Status: Completed
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Drug: CC-220; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 289
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1015ABO
    • Organizacion Medica de Investigacion
  • Buenos Aires, Argentina, C1280AEB
    • Hospital Britanico de Buenos Aires
  • Buenos Aires, Argentina, C1221ADC
    • Hospital General de Agudos Dr. Jose Maria Ramos Mejia
  • Buenos Aires, Argentina, C1015ABO
    • Local Institution - 628
  • Buenos Aires, Argentina, C1221ADC
    • Local Institution - 625
  • Cordoba, Argentina, 5000
    • Consultora Integral de Salud Centro Médico Privado
  • Cordoba, Argentina, X5016
    • Hospital Privado Centro Medico de Cordoba
  • Cordoba, Argentina, 5000
    • Local Institution - 626
  • Quilmes, Argentina, B1878DVB
    • Cer Instituto Medico
  • Quilmes, Argentina, B1878GEG
    • Instituto de Investigaciones Clinicas de Quilmes
  • Quilmes, Argentina, B1878DVB
    • Local Institution - 630
  • Quilmes, Argentina, B1878GEG
    • Local Institution - 629
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Centro Medico Privado de Reumatologia
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Local Institution - 627
• Belgium
  • Brussels, Belgium, 1070
    • Hopital Erasme
  • Brussels, Belgium, 1070
    • Local Institution - 425
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
  • Leuven, Belgium, 3000
    • Local Institution - 427
  • Liège, Belgium, 4000
    • CHU de Liège
  • Liège, Belgium, 4000
    • Local Institution - 426
• Brazil
  • Belo Horizonte, Brazil, 30150-221
    • Santa Casa de Misericordia de Belo Horizonte
  • Belo Horizonte, Brazil, 30150-221
    • Local Institution - 652
  • Porto Alegre, RS, Brazil, 90035-003
    • Hospital de Clinicas de Porto Alegre
  • Rio de Janeiro, Brazil, 22411-001
    • Centro de Imunoterapia de Ipanema (CITIPA)
  • Rio de Janeiro, Brazil, 22411-001
    • Local Institution - 651
  • Goiás
    • Goiânia, Goiás, Brazil, 74110-120
      • Centro Internacional de Pesquisas
    • Goiânia, Goiás, Brazil, 74110-120
      • Local Institution - 655
  • Paraná
    • Curitiba, Paraná, Brazil, 80030
      • Centro de Estudos em Terapias Inovadoras LTDA
    • Curitiba, Paraná, Brazil, 80030
      • Local Institution - 653
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90480
      • LMK Serviços Médicos S/S
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90480
      • Local Institution - 650
  • São Paulo
    • Campinas, São Paulo, Brazil, 13083-888
      • State University of Campinas UNICAMP
    • Campinas, São Paulo, Brazil, 13083-888
      • Local Institution - 657
• Canada
  • Quebec, Canada, G1V 4G2
    • CHUL du CHU de Québec
  • Quebec, Canada, G8Z 1Y2
    • Clinique de Rhumatologie Du Centre Du Quebec
  • Quebec, Canada, G1V 4G2
    • Local Institution - 203
  • Quebec, Canada, G8Z 1Y2
    • Local Institution - 200
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • The University Of Calgary
    • Calgary, Alberta, Canada, T2N 4Z6
      • Local Institution - 205
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3Y1X7
      • University of Manitoba
    • Winnipeg, Manitoba, Canada, R3Y1X7
      • Local Institution - 204
  • Ontario
    • Hamilton, Ontario, Canada, L8N 2B6
      • MAC Research Incorporated
    • Hamilton, Ontario, Canada, L8N 2B6
      • Local Institution - 201
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
    • Toronto, Ontario, Canada, M5T 2S8
      • Local Institution - 202
• Colombia
  • Barranquilla, Colombia, 080002
    • IPS Centro Integral de Reumatologia del Caribe Circaribe S.A.S.
  • Barranquilla, Colombia, 080002
    • Local Institution - 675
  • Bogota, Colombia, 110221
    • Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S. - Cireem S.A.S
  • Bogota, Colombia, 111211
    • Idearg S.A.S.
  • Bogota, Colombia, 110221
    • Local Institution - 682
  • Bogota, Colombia, 111211
    • Local Institution - 676
  • Bucaramanga, Colombia, 680003
    • Medicity S.A.S.
  • Bucaramanga, Colombia, 680003
    • Servimed S.A.S.
  • Bucaramanga, Colombia, 680003
    • Local Institution - 679
  • Chia, Colombia, 250001
    • Preventive Care
  • Chia, Colombia, 250001
    • Local Institution - 677
  • Medellin, Colombia, 050034
    • Hospital Pablo Tobon Uribe
  • Medellin, Colombia, 050010
    • Reumalab - Centro Integral de Reumatologia
  • Medellin, Colombia, 050010
    • Local Institution - 678
  • Medellin, Colombia, 050034
    • Local Institution - 680
• France
  • Lille Cedex, France, 59037
    • CHRU de Lille France
  • Paris, France, 75651
    • Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere
  • Paris, France, 75651
    • Local Institution - 326
  • Strasbourg, France, 67098
    • CHU HautePierre
• Germany
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein
  • Kiel, Germany, 24105
    • Local Institution - 302
  • Koeln, Germany, 50937
    • Universitaetsklinikum Koeln
  • Koeln, Germany, 50937
    • Local Institution - 300
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
• Hungary
  • Budapest, Hungary, 1097
    • Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet
  • Budapest, Hungary, 1036
    • Qualiclinic Kft
  • Budapest, Hungary, 1036
    • Local Institution - 352
  • Budapest, Hungary, 1097
    • Local Institution - 350
  • Gyula, Hungary, 5700
    • Békés Megyei Központi Kórház
  • Gyula, Hungary, 5700
    • Local Institution - 351
• Italy
  • Brescia, Italy, 25123
    • ASST Spedali Civili P.O. di Brescia
  • Ferrara, Italy, 44124
    • University of Ferrara, Azienda Ospedaliera-Universitaria S.Anna
  • Monserrato, Italy, 09042
    • Azienda Ospedaliero - Universitaria di Cagliari
• Mexico
  • D.f, Df, Mexico, 07760
    • Hospital Angeles Lindavista
  • D.f, Df, Mexico, 07760
    • Local Institution - 606
  • Baja California
    • Mexicali, Baja California, Mexico, 21200
      • Centro de Investigación en Artritis y Osteoporosis
    • Mexicali, Baja California, Mexico, 21200
      • Local Institution - 610
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 06700
      • Biológicos Especializados S.A. de C.V.
    • Mexico, Distrito Federal, Mexico, 06760
      • Clinica Integral de Osteoporosis y Artitis Reumatoide CLINOSAR
    • Mexico, Distrito Federal, Mexico, 44690
      • Centro de Investigación y Tratamiento Reumatológico
    • Mexico, Distrito Federal, Mexico, 06700
      • Local Institution - 602
    • Mexico, Distrito Federal, Mexico, 06760
      • Local Institution - 608
    • Mexico, Distrito Federal, Mexico, 44690
      • Local Institution - 607
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Centro Integral en Reumatología, S.A. de C.V.
    • Guadalajara, Jalisco, Mexico, 44160
      • Local Institution - 600
  • San Luis Potosí
    • San Luis Potosi, San Luis Potosí, Mexico, 78213
      • Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.
    • San Luis Potosi, San Luis Potosí, Mexico, 78213
      • Local Institution - 603
  • Yucatán
    • Merida, Yucatán, Mexico, 97130
      • Unidad de Atencion Medica e Investigacion en Salud, S.C.
    • Merida, Yucatán, Mexico, 97130
      • Local Institution - 605
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
  • Bydgoszcz, Poland, 85-168
    • Local Institution - 377
  • Koscian, Poland, 64-000
    • Samodzielny Publiczny Zespól Opieki Zdrowotnej w Koscianie Szpital im. Teodora Dunina
  • Koscian, Poland, 64-000
    • Local Institution - 376
  • Krakow, Poland, 30-349
    • Centrum Medyczne Plejady
  • Krakow, Poland, 30-349
    • Local Institution - 375
  • Lublin, Poland, 20-954
    • Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Reumatologii i Ukladowych Chorob Tkanki Laczne
  • Lublin, Poland, 20-954
    • Local Institution - 378
  • Wroclaw, Poland, 53-224
    • Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
  • Woj. Dolnoslaskie
    • Wroclaw, Woj. Dolnoslaskie, Poland, 53-224
      • Local Institution - 380
• Russian Federation
  • Kazan, Russian Federation, 420103
    • City Clinical Hospital
  • Kazan, Russian Federation, 420103
    • Local Institution - 506
  • Kemerovo, Russian Federation, 650066
    • Kemerovo State Medical Academy
  • Kemerovo, Russian Federation, 650066
    • Local Institution - 505
  • Moscow, Russian Federation, 115522
    • Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru
  • Moscow, Russian Federation, 115522
    • Local Institution - 507
  • Orenburg, Russian Federation, 460000
    • Orenburg State Medical Academy
  • Orenburg, Russian Federation, 460000
    • Local Institution - 500
  • St. Petersburg, Russian Federation, 194291
    • Leningrad Regional Clinical Hospital
  • St. Petersburg, Russian Federation, 192242
    • Saint Petersburg Research Institute for Emergency Medical Care
  • St. Petersburg, Russian Federation, 195067
    • State Higher Educational Institution
  • St. Petersburg, Russian Federation, 194291
    • Local Institution - 502
  • St. Petersburg, Russian Federation, 195067
    • Local Institution - 503
  • Vladimir, Russian Federation, 600005
    • BioMed, LLC.
  • Vladimir, Russian Federation, 600005
    • Local Institution - 504
  • Voronezh, Russian Federation, 394066
    • Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology Belgrade
  • Belgrade, Serbia, 11000
    • Local Institution - 475
  • Belgrade, Serbia, 11000
    • Local Institution - 476
  • Belgrade, Serbia, 11000
    • Local Institution - 477
  • Belgrade, Serbia, 11000
    • Local Institution - 478
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • Kragujevac, Serbia, 34000
    • Local Institution - 480
  • Niska Banja, Serbia, 18205
    • Institute Niska Banja
  • Niska Banja, Serbia, 18205
    • Local Institution - 479
• Spain
  • A Coruña, Spain, 15006
    • Hospital Universitario A Coruña
  • A Coruña, Spain, 15006
    • Local Institution - 400
  • Barcelona, Spain, 28040
    • Hospital Universitario Vall d Hebron
  • Barcelona, Spain, 28040
    • Local Institution - 403
  • La Laguna, Spain, 38320
    • Hospital Universitario de Canarias
  • Santander, Spain, 39008
    • Hospital Marques de Valdecilla
  • Santander, Spain, 39008
    • Local Institution - 405
  • Vitoria-Gasteiz, Spain, 01009
    • Hospital Universitario Araba - Txagorritxu
• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35406
      • Clinical and Translational Research Center of Alabama, PC
  • Arizona
    • Mesa, Arizona, United States, 85202
      • AZ Arthritis and Rheum Rsch, PLLC
  • California
    • Fullerton, California, United States, 92835
      • Saint Jude Heritage Medical Center
    • La Jolla, California, United States, 92037
      • University of California San Diego Medical Center
    • Los Angeles, California, United States, 90095
      • UCLA Division of Rheumatology
    • Palm Desert, California, United States, 92260
      • Desert Medical Advances
    • San Leandro, California, United States, 94578
      • C Michael Neuwelt M D
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
  • Florida
    • Fort Lauderdale, Florida, United States, 33334
      • Centre For Rheumatology, Immun. And Arthritis
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Medicine
    • Miami, Florida, United States, 33136
      • University of Miami
    • Plantation, Florida, United States, 33324
      • Integral Rheumatology And Immunology Specialists
    • Tampa, Florida, United States, 33614
      • Bay Care Medical Group
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University School of Medicine
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital - Atlanta
    • Decatur, Georgia, United States, 30033-5910
      • Jefrey Lieberman, MD, PC
    • Lawrenceville, Georgia, United States, 30046
      • North Georgia Rheumatology
  • Illinois
    • Skokie, Illinois, United States, 60076
      • Clinic of Robert Hozman
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland - School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconness Medical Center
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Advanced Rheumatology
    • Lansing, Michigan, United States, 48910
      • Great Lakes Center of Rheumatology
  • New Mexico
    • Las Cruces, New Mexico, United States, 88011-4741
      • Arthritis and Osteoporosis Associates of New Mexico
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Great Neck, New York, United States, 11021
      • North Shore-LIJ Health System-Division of Rheumatology
    • Great Neck, New York, United States, 11021
      • Local Institution - 134
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
    • Syracuse, New York, United States, 13210
      • Local Institution - 124
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • DJL Clinical Research
    • Charlotte, North Carolina, United States, 28210
      • Local Institution - 101
    • Raleigh, North Carolina, United States, 27617
      • Shanahan Rheumatology and Immunotherapy
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Systems
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • St. Anthony's Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-8807
      • Hershey Medical Center
    • Hershey, Pennsylvania, United States, 17033-8807
      • Local Institution - 136
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Department of Dermatology
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh UPMC Lupus Center of Excellence
    • Wexford, Pennsylvania, United States, 15090
      • Advanced Rheumatology & Arthritis Research Center, PC
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Houston, Texas, United States, 77099
      • Pioneer Research Solutions
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CC-220 0.45 mg QD Placebo Controlled Phase; 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.	Drug: CC-220; CC-220; Other: Placebo; Placebo QD PO
Experimental: C-220 0.3 mg QD Placebo Controlled 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.	Drug: CC-220; CC-220; Other: Placebo; Placebo QD PO
Experimental: CC-220 0.15 mg QD Placebo Controlled 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.	Drug: CC-220; CC-220; Other: Placebo; Placebo QD PO
Placebo Comparator: Placebo; Weeks 0 to 24: CC-220 Placebo Controlled Phase: placebo once daily (QD)	Other: Placebo; Placebo QD PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 24
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.	Week 24
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.	Week 24
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.	Week 24
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.	Week 24
The Total Corticosteroid Dose From Baseline Through Week 24	Standardized total oral corticosteroid (OCS) dose.	Through Week 24
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Number of participants who experienced a TEAE during the course of the study	from first dose to 28 days post-last dose through Week 24 (placebo-controlled phase), approximately 28 weeks total
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.	Week 24
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.	Week 24
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.	Week 24
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	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.	Week 24

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Nataliya Agafonova, MD, Celgene Corporation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Actual): August 3, 2021
• Study Completion (Actual): August 3, 2021

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Efficacy; CC-220; Active Systemic Lupus Erythematosus
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: CC-220-SLE-002; U1111-1195-7804 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No