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AzTrials

Lupus Erythematosus, SystemicPhase 2NCT03161483

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

A Phase 2 study testing CC-220 in people with Lupus Erythematosus, Systemic, run by Celgene at 184 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
CC-220
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
289 participants
Where
184 sitesin 15 countries
Study dates
31 Aug 2017to 3 Aug 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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).
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  • 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

Trial locations and contacts

184 sites in 15 countries.

184 sites in 15 countries

United States46 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30303

  • Piedmont Hospital - Atlanta

    Atlanta, Georgia, 30309

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • University of Maryland - School of Medicine

    Baltimore, Maryland, 21201

  • Beth Israel Deaconness Medical Center

    Boston, Massachusetts, 02215

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • DJL Clinical Research

    Charlotte, North Carolina, 28210

  • Local Institution - 101

    Charlotte, North Carolina, 28210

  • MetroHealth Medical Systems

    Cleveland, Ohio, 44109

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Jefrey Lieberman, MD, PC

    Decatur, Georgia, 30033-5910

  • Centre For Rheumatology, Immun. And Arthritis

    Fort Lauderdale, Florida, 33334

  • Saint Jude Heritage Medical Center

    Fullerton, California, 92835

  • University of Florida College of Medicine

    Gainesville, Florida, 32610

  • Local Institution - 134

    Great Neck, New York, 11021

  • North Shore-LIJ Health System-Division of Rheumatology

    Great Neck, New York, 11021

  • Hershey Medical Center

    Hershey, Pennsylvania, 17033-8807

  • Local Institution - 136

    Hershey, Pennsylvania, 17033-8807

  • Pioneer Research Solutions

    Houston, Texas, 77099

  • University of California San Diego Medical Center

    La Jolla, California, 92037

  • Advanced Rheumatology

    Lansing, Michigan, 48910

  • Great Lakes Center of Rheumatology

    Lansing, Michigan, 48910

  • Arthritis and Osteoporosis Associates of New Mexico

    Las Cruces, New Mexico, 88011-4741

  • North Georgia Rheumatology

    Lawrenceville, Georgia, 30046

  • UCLA Division of Rheumatology

    Los Angeles, California, 90095

  • AZ Arthritis and Rheum Rsch, PLLC

    Mesa, Arizona, 85202

  • University of Miami

    Miami, Florida, 33136

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • NYU Langone Medical Center

    New York, New York, 10016

  • St. Anthony's Medical Center

    Oklahoma City, Oklahoma, 73102

  • Desert Medical Advances

    Palm Desert, California, 92260

  • University of Pennsylvania Department of Dermatology

    Philadelphia, Pennsylvania, 19104

  • University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh UPMC Lupus Center of Excellence

    Pittsburgh, Pennsylvania, 15213

  • Integral Rheumatology and Immunology Specialists

    Plantation, Florida, 33324

  • Shanahan Rheumatology and Immunotherapy

    Raleigh, North Carolina, 27617

  • C Michael Neuwelt M D

    San Leandro, California, 94578

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Clinic of Robert Hozman

    Skokie, Illinois, 60076

  • Local Institution - 124

    Syracuse, New York, 13210

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Bay Care Medical Group

    Tampa, Florida, 33614

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Clinical and Translational Research Center of Alabama, PC

    Tuscaloosa, Alabama, 35406

  • Inland Rheumatology Clinical Trials

    Upland, California, 91786

  • Advanced Rheumatology & Arthritis Research Center, PC

    Wexford, Pennsylvania, 15090

Other trials in United States

Mexico16 sites

  • Hospital Angeles Lindavista

    D.F, DF, 07760

  • Local Institution - 606

    D.F, DF, 07760

  • Centro Integral en Reumatología, S.A. de C.V.

    Guadalajara, Jalisco, 44160

  • Local Institution - 600

    Guadalajara, Jalisco, 44160

  • Local Institution - 605

    Mérida, Yucatán, 97130

  • Unidad de Atencion Medica e Investigacion en Salud, S.C.

    Mérida, Yucatán, 97130

  • Centro de Investigacion en Artritis y Osteoporosis

    Mexicali, Estado de Baja California, 21200

  • Local Institution - 610

    Mexicali, Estado de Baja California, 21200

  • Biológicos Especializados S.A. de C.V.

    Mexico City, Mexico City, 06700

  • Local Institution - 602

    Mexico City, Mexico City, 06700

  • Clinica Integral de Osteoporosis y Artitis Reumatoide CLINOSAR

    Mexico City, Mexico City, 06760

  • Local Institution - 608

    Mexico City, Mexico City, 06760

  • Centro de Investigación y Tratamiento Reumatológico

    Mexico City, Mexico City, 44690

  • Local Institution - 607

    Mexico City, Mexico City, 44690

  • Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.

    San Luis Potosí City, San Luis Potosí, 78213

  • Local Institution - 603

    San Luis Potosí City, San Luis Potosí, 78213

Other trials in Mexico

Russia16 sites

  • City Clinical Hospital

    Kazan', 420103

  • Local Institution - 506

    Kazan', 420103

  • Kemerovo State Medical Academy

    Kemerovo, 650066

  • Local Institution - 505

    Kemerovo, 650066

  • Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru

    Moscow, 115522

  • Local Institution - 507

    Moscow, 115522

  • Local Institution - 500

    Orenburg, 460000

  • Orenburg State Medical Academy

    Orenburg, 460000

  • Saint Petersburg Research Institute for Emergency Medical Care

    Saint Petersburg, 192242

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • Local Institution - 502

    Saint Petersburg, 194291

  • Local Institution - 503

    Saint Petersburg, 195067

  • State Higher Educational Institution

    Saint Petersburg, 195067

  • BioMed, LLC.

    Vladimir, 600005

  • Local Institution - 504

    Vladimir, 600005

  • Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy

    Voronezh, 394066

Other trials in Russia

Colombia15 sites

  • IPS Centro Integral de Reumatologia del Caribe Circaribe S.A.S.

    Barranquilla, 080002

  • Local Institution - 675

    Barranquilla, 080002

  • Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S. - Cireem S.A.S

    Bogotá, 110221

  • Local Institution - 682

    Bogotá, 110221

  • Idearg S.A.S.

    Bogotá, 111211

  • Local Institution - 676

    Bogotá, 111211

  • Local Institution - 679

    Bucaramanga, 680003

  • Medicity S.A.S.

    Bucaramanga, 680003

  • Servimed S.A.S.

    Bucaramanga, 680003

  • Local Institution - 677

    Chía, 250001

  • Preventive Care

    Chía, 250001

  • Local Institution - 678

    Medellín, 050010

  • Reumalab - Centro Integral de Reumatologia

    Medellín, 050010

  • Hospital Pablo Tobon Uribe

    Medellín, 050034

  • Local Institution - 680

    Medellín, 050034

Other trials in Colombia

Argentina14 sites

  • Local Institution - 628

    Buenos Aires, C1015ABO

  • Organización Médica de Investigación

    Buenos Aires, C1015ABO

  • Hospital General de Agudos Dr. Jose Maria Ramos Mejia

    Buenos Aires, C1221ADC

  • Local Institution - 625

    Buenos Aires, C1221ADC

  • Hospital Britanico de Buenos Aires

    Buenos Aires, C1280AEB

  • Consultora Integral de Salud Centro Médico Privado

    Córdoba, 5000

  • Local Institution - 626

    Córdoba, 5000

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016

  • CER Instituto Mèdico

    Quilmes, B1878DVB

  • Local Institution - 630

    Quilmes, B1878DVB

  • Instituto de Investigaciones Clinicas de Quilmes

    Quilmes, B1878GEG

  • Local Institution - 629

    Quilmes, B1878GEG

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucumán, T4000AXL

  • Local Institution - 627

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Brazil13 sites

  • Local Institution - 652

    Belo Horizonte, 30150-221

  • Santa Casa de Misericórdia de Belo Horizonte

    Belo Horizonte, 30150-221

  • Local Institution - 657

    Campinas, São Paulo, 13083-888

  • State University of Campinas UNICAMP

    Campinas, São Paulo, 13083-888

  • Centro de Estudos em Terapias Inovadoras LTDA

    Curitiba, Paraná, 80030

  • Local Institution - 653

    Curitiba, Paraná, 80030

  • Centro Internacional de Pesquisas

    Goiânia, Goiás, 74110-120

  • Local Institution - 655

    Goiânia, Goiás, 74110-120

  • LMK Servicos Medicos S/S

    Porto Alegre, Rio Grande do Sul, 90480

  • Local Institution - 650

    Porto Alegre, Rio Grande do Sul, 90480

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, RS, 90035-003

  • Centro de Imunoterapia de Ipanema (CITIPA)

    Rio de Janeiro, 22411-001

  • Local Institution - 651

    Rio de Janeiro, 22411-001

Other trials in Brazil

Canada12 sites

  • Local Institution - 205

    Calgary, Alberta, T2N 4Z6

  • The University of Calgary

    Calgary, Alberta, T2N 4Z6

  • Local Institution - 201

    Hamilton, Ontario, L8N 2B6

  • MAC Research Incorporated

    Hamilton, Ontario, L8N 2B6

  • CHUL du CHU de Quebec

    Québec, G1V 4G2

  • Local Institution - 203

    Québec, G1V 4G2

  • Clinique de Rhumatologie Du Centre Du Quebec

    Québec, G8Z 1Y2

  • Local Institution - 200

    Québec, G8Z 1Y2

  • Local Institution - 202

    Toronto, Ontario, M5T 2S8

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Local Institution - 204

    Winnipeg, Manitoba, R3Y1X7

  • University of Manitoba

    Winnipeg, Manitoba, R3Y1X7

Other trials in Canada

Poland10 sites

  • Local Institution - 377

    Bydgoszcz, 85-168

  • Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Local Institution - 376

    Kościan, 64-000

  • Samodzielny Publiczny Zespól Opieki Zdrowotnej w Koscianie Szpital im. Teodora Dunina

    Kościan, 64-000

  • Centrum Medyczne Plejady

    Krakow, 30-349

  • Local Institution - 375

    Krakow, 30-349

  • Local Institution - 378

    Lublin, 20-954

  • Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Reumatologii i Ukladowych Chorob Tkanki Laczne

    Lublin, 20-954

  • Local Institution - 380

    Wroclaw, Woj. Dolnoslaskie, 53-224

  • Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.

    Wroclaw, 53-224

Other trials in Poland

Serbia10 sites

  • Institute of Rheumatology Belgrade

    Belgrade, 11000

  • Local Institution - 475

    Belgrade, 11000

  • Local Institution - 476

    Belgrade, 11000

  • Local Institution - 477

    Belgrade, 11000

  • Local Institution - 478

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Local Institution - 480

    Kragujevac, 34000

  • Institute Niska Banja

    Niška Banja, 18205

  • Local Institution - 479

    Niška Banja, 18205

Other trials in Serbia

Spain8 sites

  • Hospital Universitario a Coruna

    A Coruña, 15006

  • Local Institution - 400

    A Coruña, 15006

  • Hospital Universitario Vall D hebron

    Barcelona, 28040

  • Local Institution - 403

    Barcelona, 28040

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38320

  • Hospital Marques de Valdecilla

    Santander, 39008

  • Local Institution - 405

    Santander, 39008

  • Hospital Universitario Araba - Txagorritxu

    Vitoria-Gasteiz, 01009

Other trials in Spain

Belgium6 sites

  • Hopital Erasme

    Brussels, 1070

  • Local Institution - 425

    Brussels, 1070

  • Local Institution - 427

    Leuven, 3000

  • Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg

    Leuven, 3000

  • CHU de Liege

    Liège, 4000

  • Local Institution - 426

    Liège, 4000

Other trials in Belgium

Hungary6 sites

  • Local Institution - 352

    Budapest, 1036

  • Qualiclinic kft

    Budapest, 1036

  • Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet

    Budapest, 1097

  • Local Institution - 350

    Budapest, 1097

  • Bekes Megyei Kozponti Korhaz

    Gyula, 5700

  • Local Institution - 351

    Gyula, 5700

Other trials in Hungary

Germany5 sites

  • Local Institution - 300

    Cologne, 50937

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Local Institution - 302

    Kiel, 24105

  • Universitatsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

Other trials in Germany

France4 sites

  • CHRU de Lille France

    Lille, 59037

  • Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere

    Paris, 75651

  • Local Institution - 326

    Paris, 75651

  • CHU Hautepierre

    Strasbourg, 67098

Other trials in France

Italy3 sites

  • ASST Spedali Civili P.O. di Brescia

    Brescia, 25123

  • University of Ferrara, Azienda Ospedaliera-Universitaria S.Anna

    Ferrara, 44124

  • Azienda Ospedaliero - Universitaria di Cagliari

    Monserrato, 09042

Other trials in Italy

About this study

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

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.

Read the 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.
Being tested
CC-220, Placebo
Keywords
CC-220, Safety, Efficacy, Active Systemic Lupus Erythematosus
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-220Drug

    CC-220

  • PlaceboOther

    Placebo QD PO

Study groups in NCT03161483
Study groupRoleWhat they receive
CC-220 0.45 mg QD Placebo Controlled PhaseExperimental* 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.
Receives: Drug: CC-220; Other: Placebo
C-220 0.3 mg QD Placebo Controlled PhaseExperimental* 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.
Receives: Drug: CC-220; Other: Placebo
CC-220 0.15 mg QD Placebo Controlled PhaseExperimental* 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.
Receives: Drug: CC-220; Other: Placebo
PlaceboPlacebo comparatorWeeks 0 to 24: CC-220 Placebo Controlled Phase: placebo once daily (QD)
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 24

Secondary outcomes (12)

  1. 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.

    Measured: Week 24

  2. 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.

    Measured: Week 24

  3. 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.

    Measured: Week 24

  4. 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.

    Measured: Week 24

  5. 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.

    Measured: Week 24

  6. 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.

    Measured: Week 24

  7. 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.

    Measured: Week 24

  8. 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.

    Measured: Week 24

  9. 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

    Measured: Week 24

  10. 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.

    Measured: Week 24

  11. The Total Corticosteroid Dose From Baseline Through Week 24

    Standardized total oral corticosteroid (OCS) dose.

    Measured: Through Week 24

  12. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Number of participants who experienced a TEAE during the course of the study

    Measured: from first dose to 28 days post-last dose through Week 24 (placebo-controlled phase), approximately 28 weeks total

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2017
  2. Study start31 Aug 2017
  3. Primary completion3 Aug 2021
  4. Study completion3 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
289 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03161483
Sponsor's protocol ID
CC-220-SLE-002
Other IDs
U1111-1195-7804
Status last verified
Jun 2023
First submitted
18 May 2017
Last updated
15 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28848067

  • 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.

    PubMed 35477518

  • 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.

    PubMed 35294813

  • 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.

    PubMed 33687069

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CC-220 in people with Lupus Erythematosus, Systemic, run by Celgene at 184 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 184 sites in United States, Mexico, Russia, Colombia, Argentina and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Achieve SLE Responder Index (SRI) (4) Response (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03161483, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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