A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus
NCT ID: NCT03161483
Last Updated: 2023-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
289 participants
INTERVENTIONAL
2017-08-31
2021-08-03
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
CC-220
CC-220
Placebo
Placebo QD PO
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.
CC-220
CC-220
Placebo
Placebo QD PO
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.
CC-220
CC-220
Placebo
Placebo QD PO
Placebo
Weeks 0 to 24: CC-220 Placebo Controlled Phase: placebo once daily (QD)
Placebo
Placebo QD PO
Interventions
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CC-220
CC-220
Placebo
Placebo QD PO
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Nataliya Agafonova, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Clinical and Translational Research Center of Alabama, PC
Tuscaloosa, Alabama, United States
AZ Arthritis and Rheum Rsch, PLLC
Mesa, Arizona, United States
Saint Jude Heritage Medical Center
Fullerton, California, United States
University of California San Diego Medical Center
La Jolla, California, United States
UCLA Division of Rheumatology
Los Angeles, California, United States
Desert Medical Advances
Palm Desert, California, United States
C Michael Neuwelt M D
San Leandro, California, United States
Inland Rheumatology Clinical Trials
Upland, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Centre For Rheumatology, Immun. And Arthritis
Fort Lauderdale, Florida, United States
University of Florida College of Medicine
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Integral Rheumatology and Immunology Specialists
Plantation, Florida, United States
Bay Care Medical Group
Tampa, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Piedmont Hospital - Atlanta
Atlanta, Georgia, United States
Jefrey Lieberman, MD, PC
Decatur, Georgia, United States
North Georgia Rheumatology
Lawrenceville, Georgia, United States
Clinic of Robert Hozman
Skokie, Illinois, United States
University of Maryland - School of Medicine
Baltimore, Maryland, United States
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States
Advanced Rheumatology
Lansing, Michigan, United States
Great Lakes Center of Rheumatology
Lansing, Michigan, United States
Arthritis and Osteoporosis Associates of New Mexico
Las Cruces, New Mexico, United States
Local Institution - 134
Great Neck, New York, United States
North Shore-LIJ Health System-Division of Rheumatology
Great Neck, New York, United States
NYU Langone Medical Center
New York, New York, United States
Local Institution - 124
Syracuse, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
DJL Clinical Research
Charlotte, North Carolina, United States
Local Institution - 101
Charlotte, North Carolina, United States
Shanahan Rheumatology and Immunotherapy
Raleigh, North Carolina, United States
MetroHealth Medical Systems
Cleveland, Ohio, United States
St. Anthony's Medical Center
Oklahoma City, Oklahoma, United States
Hershey Medical Center
Hershey, Pennsylvania, United States
Local Institution - 136
Hershey, Pennsylvania, United States
University of Pennsylvania Department of Dermatology
Philadelphia, Pennsylvania, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh UPMC Lupus Center of Excellence
Pittsburgh, Pennsylvania, United States
Advanced Rheumatology & Arthritis Research Center, PC
Wexford, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Local Institution - 628
Buenos Aires, , Argentina
Organización Médica de Investigación
Buenos Aires, , Argentina
Hospital General de Agudos Dr. Jose Maria Ramos Mejia
Buenos Aires, , Argentina
Local Institution - 625
Buenos Aires, , Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, , Argentina
Consultora Integral de Salud Centro Médico Privado
Córdoba, , Argentina
Local Institution - 626
Córdoba, , Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, , Argentina
CER Instituto Mèdico
Quilmes, , Argentina
Local Institution - 630
Quilmes, , Argentina
Instituto de Investigaciones Clinicas de Quilmes
Quilmes, , Argentina
Local Institution - 629
Quilmes, , Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, , Argentina
Local Institution - 627
San Miguel de Tucumán, , Argentina
Hopital Erasme
Brussels, , Belgium
Local Institution - 425
Brussels, , Belgium
Local Institution - 427
Leuven, , Belgium
Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
Leuven, , Belgium
CHU de Liege
Liège, , Belgium
Local Institution - 426
Liège, , Belgium
Centro Internacional de Pesquisas
Goiânia, Goiás, Brazil
Local Institution - 655
Goiânia, Goiás, Brazil
Centro de Estudos em Terapias Inovadoras LTDA
Curitiba, Paraná, Brazil
Local Institution - 653
Curitiba, Paraná, Brazil
LMK Servicos Medicos S/S
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 650
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 657
Campinas, São Paulo, Brazil
State University of Campinas UNICAMP
Campinas, São Paulo, Brazil
Local Institution - 652
Belo Horizonte, , Brazil
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, , Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, , Brazil
Centro de Imunoterapia de Ipanema (CITIPA)
Rio de Janeiro, , Brazil
Local Institution - 651
Rio de Janeiro, , Brazil
Local Institution - 205
Calgary, Alberta, Canada
The University of Calgary
Calgary, Alberta, Canada
Local Institution - 204
Winnipeg, Manitoba, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Local Institution - 201
Hamilton, Ontario, Canada
MAC Research Incorporated
Hamilton, Ontario, Canada
Local Institution - 202
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
CHUL du CHU de Quebec
Québec, , Canada
Local Institution - 203
Québec, , Canada
Clinique de Rhumatologie Du Centre Du Quebec
Québec, , Canada
Local Institution - 200
Québec, , Canada
IPS Centro Integral de Reumatologia del Caribe Circaribe S.A.S.
Barranquilla, , Colombia
Local Institution - 675
Barranquilla, , Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S. - Cireem S.A.S
Bogotá, , Colombia
Local Institution - 682
Bogotá, , Colombia
Idearg S.A.S.
Bogotá, , Colombia
Local Institution - 676
Bogotá, , Colombia
Local Institution - 679
Bucaramanga, , Colombia
Medicity S.A.S.
Bucaramanga, , Colombia
Servimed S.A.S.
Bucaramanga, , Colombia
Local Institution - 677
Chía, , Colombia
Preventive Care
Chía, , Colombia
Local Institution - 678
Medellín, , Colombia
Reumalab - Centro Integral de Reumatologia
Medellín, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Local Institution - 680
Medellín, , Colombia
CHRU de Lille France
Lille, , France
Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere
Paris, , France
Local Institution - 326
Paris, , France
CHU Hautepierre
Strasbourg, , France
Local Institution - 300
Cologne, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
Local Institution - 302
Kiel, , Germany
Universitatsklinikum Schleswig-Holstein
Kiel, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Local Institution - 352
Budapest, , Hungary
Qualiclinic kft
Budapest, , Hungary
Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet
Budapest, , Hungary
Local Institution - 350
Budapest, , Hungary
Bekes Megyei Kozponti Korhaz
Gyula, , Hungary
Local Institution - 351
Gyula, , Hungary
ASST Spedali Civili P.O. di Brescia
Brescia, , Italy
University of Ferrara, Azienda Ospedaliera-Universitaria S.Anna
Ferrara, , Italy
Azienda Ospedaliero - Universitaria di Cagliari
Monserrato, , Italy
Centro de Investigacion en Artritis y Osteoporosis
Mexicali, Estado de Baja California, Mexico
Local Institution - 610
Mexicali, Estado de Baja California, Mexico
Centro Integral en Reumatología, S.A. de C.V.
Guadalajara, Jalisco, Mexico
Local Institution - 600
Guadalajara, Jalisco, Mexico
Biológicos Especializados S.A. de C.V.
Mexico City, Mexico City, Mexico
Local Institution - 602
Mexico City, Mexico City, Mexico
Clinica Integral de Osteoporosis y Artitis Reumatoide CLINOSAR
Mexico City, Mexico City, Mexico
Local Institution - 608
Mexico City, Mexico City, Mexico
Centro de Investigación y Tratamiento Reumatológico
Mexico City, Mexico City, Mexico
Local Institution - 607
Mexico City, Mexico City, Mexico
Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.
San Luis Potosí City, San Luis Potosí, Mexico
Local Institution - 603
San Luis Potosí City, San Luis Potosí, Mexico
Local Institution - 605
Mérida, Yucatán, Mexico
Unidad de Atencion Medica e Investigacion en Salud, S.C.
Mérida, Yucatán, Mexico
Hospital Angeles Lindavista
D.F, DF, , Mexico
Local Institution - 606
D.F, DF, , Mexico
Local Institution - 380
Wroclaw, Woj. Dolnoslaskie, Poland
Local Institution - 377
Bydgoszcz, , Poland
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Local Institution - 376
Kościan, , Poland
Samodzielny Publiczny Zespól Opieki Zdrowotnej w Koscianie Szpital im. Teodora Dunina
Kościan, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Local Institution - 375
Krakow, , Poland
Local Institution - 378
Lublin, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Reumatologii i Ukladowych Chorob Tkanki Laczne
Lublin, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
Wroclaw, , Poland
City Clinical Hospital
Kazan', , Russia
Local Institution - 506
Kazan', , Russia
Kemerovo State Medical Academy
Kemerovo, , Russia
Local Institution - 505
Kemerovo, , Russia
Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru
Moscow, , Russia
Local Institution - 507
Moscow, , Russia
Local Institution - 500
Orenburg, , Russia
Orenburg State Medical Academy
Orenburg, , Russia
Saint Petersburg Research Institute for Emergency Medical Care
Saint Petersburg, , Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, , Russia
Local Institution - 502
Saint Petersburg, , Russia
Local Institution - 503
Saint Petersburg, , Russia
State Higher Educational Institution
Saint Petersburg, , Russia
BioMed, LLC.
Vladimir, , Russia
Local Institution - 504
Vladimir, , Russia
Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy
Voronezh, , Russia
Institute of Rheumatology Belgrade
Belgrade, , Serbia
Local Institution - 475
Belgrade, , Serbia
Local Institution - 476
Belgrade, , Serbia
Local Institution - 477
Belgrade, , Serbia
Local Institution - 478
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Local Institution - 480
Kragujevac, , Serbia
Institute Niska Banja
Niška Banja, , Serbia
Local Institution - 479
Niška Banja, , Serbia
Hospital Universitario a Coruna
A Coruña, , Spain
Local Institution - 400
A Coruña, , Spain
Hospital Universitario Vall D hebron
Barcelona, , Spain
Local Institution - 403
Barcelona, , Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, , Spain
Hospital Marques de Valdecilla
Santander, , Spain
Local Institution - 405
Santander, , Spain
Hospital Universitario Araba - Txagorritxu
Vitoria-Gasteiz, , Spain
Countries
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References
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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 Jul 12;81(8):1136-1142. doi: 10.1136/annrheumdis-2022-222212.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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U1111-1195-7804
Identifier Type: REGISTRY
Identifier Source: secondary_id
CC-220-SLE-002
Identifier Type: -
Identifier Source: org_study_id
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