Clinical trial NCT03161483: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus Erythematosus, Systemic
Keywords: CC-220
Safety
Efficacy
Active Systemic Lupus Erythematosus
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2017-05-19
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants Who Achieve SLE Responder Index (SRI) (4) Response
timeFrame: Week 24
Secondary outcomes:
measure: Number of Participants With SLEDAI 2K Score Improvement of ≥ 4 Points From Baseline
timeFrame: Week 24
measure: 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
timeFrame: Week 24
measure: 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
timeFrame: Week 24
measure: Percentage of Participants With no Worsening (Increase of < 0.30 Points From Baseline) in PGA Compared to Baseline
timeFrame: Week 24
measure: Mean Change From Baseline in Swollen Joint Count in Participants With ≥ 2 Swollen Joints at Baseline
timeFrame: Week 24
measure: Mean Change From Baseline in Tender Joint Count in Participants With ≥ 2 Tender Joints at Baseline
timeFrame: Week 24
measure: Mean Change From Baseline in PGA Score
timeFrame: Week 24
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
timeFrame: Week 24
measure: Percentage of Participants With Corticosteroid Reduction
timeFrame: Week 24
measure: Percent Change From Baseline in Corticosteroid Reduction
timeFrame: Week 24
measure: The Total Corticosteroid Dose From Baseline Through Week 24
timeFrame: Through Week 24
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: from first dose to 28 days post-last dose through Week 24 (placebo-controlled phase), approximately 28 weeks total
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Clinical and Translational Research Center of Alabama, PC
state: Alabama
city: Mesa
country: United States
facility: AZ Arthritis and Rheum Rsch, PLLC
state: Arizona
city: Fullerton
country: United States
facility: Saint Jude Heritage Medical Center
state: California
city: La Jolla
country: United States
facility: University of California San Diego Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Division of Rheumatology
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: San Leandro
country: United States
facility: C Michael Neuwelt M D
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Centre For Rheumatology, Immun. And Arthritis
state: Florida
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology and Immunology Specialists
state: Florida
city: Tampa
country: United States
facility: Bay Care Medical Group
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital - Atlanta
state: Georgia
city: Decatur
country: United States
facility: Jefrey Lieberman, MD, PC
state: Georgia
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology
state: Georgia
city: Skokie
country: United States
facility: Clinic of Robert Hozman
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland - School of Medicine
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconness Medical Center
state: Massachusetts
city: Lansing
country: United States
facility: Advanced Rheumatology
state: Michigan
city: Lansing
country: United States
facility: Great Lakes Center of Rheumatology
state: Michigan
city: Las Cruces
country: United States
facility: Arthritis and Osteoporosis Associates of New Mexico
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Great Neck
country: United States
facility: Local Institution - 134
state: New York
city: Great Neck
country: United States
facility: North Shore-LIJ Health System-Division of Rheumatology
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Syracuse
country: United States
facility: Local Institution - 124
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research
state: North Carolina
city: Charlotte
country: United States
facility: Local Institution - 101
state: North Carolina
city: Raleigh
country: United States
facility: Shanahan Rheumatology and Immunotherapy
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Systems
state: Ohio
city: Oklahoma City
country: United States
facility: St. Anthony's Medical Center
state: Oklahoma
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Local Institution - 136
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Department of Dermatology
state: Pennsylvania
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh UPMC Lupus Center of Excellence
state: Pennsylvania
city: Wexford
country: United States
facility: Advanced Rheumatology & Arthritis Research Center, PC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Buenos Aires
country: Argentina
facility: Local Institution - 628
city: Buenos Aires
country: Argentina
facility: Organización Médica de Investigación
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos Dr. Jose Maria Ramos Mejia
city: Buenos Aires
country: Argentina
facility: Local Institution - 625
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Cordoba
country: Argentina
facility: Consultora Integral de Salud Centro Médico Privado
city: Cordoba
country: Argentina
facility: Local Institution - 626
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba
city: Quilmes
country: Argentina
facility: CER Instituto Mèdico
city: Quilmes
country: Argentina
facility: Local Institution - 630
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas de Quilmes
city: Quilmes
country: Argentina
facility: Local Institution - 629
city: San Miguel de Tucumán
country: Argentina
facility: Centro Medico Privado de Reumatologia
city: San Miguel de Tucumán
country: Argentina
facility: Local Institution - 627
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Brussels
country: Belgium
facility: Local Institution - 425
city: Leuven
country: Belgium
facility: Local Institution - 427
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
city: Liège
country: Belgium
facility: CHU de Liege
city: Liège
country: Belgium
facility: Local Institution - 426
city: Goiânia
country: Brazil
facility: Centro Internacional de Pesquisas
state: Goiás
city: Goiânia
country: Brazil
facility: Local Institution - 655
state: Goiás
city: Curitiba
country: Brazil
facility: Centro de Estudos em Terapias Inovadoras LTDA
state: Paraná
city: Curitiba
country: Brazil
facility: Local Institution - 653
state: Paraná
city: Porto Alegre
country: Brazil
facility: LMK Servicos Medicos S/S
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution - 650
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Local Institution - 657
state: São Paulo
city: Campinas
country: Brazil
facility: State University of Campinas UNICAMP
state: São Paulo
city: Belo Horizonte
country: Brazil
facility: Local Institution - 652
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericórdia de Belo Horizonte
city: Porto Alegre, RS
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Centro de Imunoterapia de Ipanema (CITIPA)
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 651
city: Calgary
country: Canada
facility: Local Institution - 205
state: Alberta
city: Calgary
country: Canada
facility: The University of Calgary
state: Alberta
city: Winnipeg
country: Canada
facility: Local Institution - 204
state: Manitoba
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Hamilton
country: Canada
facility: Local Institution - 201
state: Ontario
city: Hamilton
country: Canada
facility: MAC Research Incorporated
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 202
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Quebec
country: Canada
facility: CHUL du CHU de Quebec
city: Quebec
country: Canada
facility: Local Institution - 203
city: Quebec
country: Canada
facility: Clinique de Rhumatologie Du Centre Du Quebec
city: Quebec
country: Canada
facility: Local Institution - 200
city: Barranquilla
country: Colombia
facility: IPS Centro Integral de Reumatologia del Caribe Circaribe S.A.S.
city: Barranquilla
country: Colombia
facility: Local Institution - 675
city: Bogota
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S. - Cireem S.A.S
city: Bogota
country: Colombia
facility: Local Institution - 682
city: Bogota
country: Colombia
facility: Idearg S.A.S.
city: Bogota
country: Colombia
facility: Local Institution - 676
city: Bucaramanga
country: Colombia
facility: Local Institution - 679
city: Bucaramanga
country: Colombia
facility: Medicity S.A.S.
city: Bucaramanga
country: Colombia
facility: Servimed S.A.S.
city: Chia
country: Colombia
facility: Local Institution - 677
city: Chia
country: Colombia
facility: Preventive Care
city: Medellin
country: Colombia
facility: Local Institution - 678
city: Medellin
country: Colombia
facility: Reumalab - Centro Integral de Reumatologia
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Medellin
country: Colombia
facility: Local Institution - 680
city: Lille Cedex
country: France
facility: CHRU de Lille France
city: Paris
country: France
facility: Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere
city: Paris
country: France
facility: Local Institution - 326
city: Strasbourg
country: France
facility: CHU Hautepierre
city: Kiel
country: Germany
facility: Local Institution - 302
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Koeln
country: Germany
facility: Local Institution - 300
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Budapest
country: Hungary
facility: Local Institution - 352
city: Budapest
country: Hungary
facility: Qualiclinic kft
city: Budapest
country: Hungary
facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet
city: Budapest
country: Hungary
facility: Local Institution - 350
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz
city: Gyula
country: Hungary
facility: Local Institution - 351
city: Brescia
country: Italy
facility: ASST Spedali Civili P.O. di Brescia
city: Ferrara
country: Italy
facility: University of Ferrara, Azienda Ospedaliera-Universitaria S.Anna
city: Monserrato
country: Italy
facility: Azienda Ospedaliero - Universitaria di Cagliari
city: Mexicali
country: Mexico
facility: Centro de Investigacion en Artritis y Osteoporosis
state: Baja California
city: Mexicali
country: Mexico
facility: Local Institution - 610
state: Baja California
city: Mexico
country: Mexico
facility: Biológicos Especializados S.A. de C.V.
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 602
state: Distrito Federal
city: Mexico
country: Mexico
facility: Clinica Integral de Osteoporosis y Artitis Reumatoide CLINOSAR
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 608
state: Distrito Federal
city: Mexico
country: Mexico
facility: Centro de Investigación y Tratamiento Reumatológico
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 607
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatología, S.A. de C.V.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution - 600
state: Jalisco
city: San Luis Potosi
country: Mexico
facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.
state: San Luis Potosí
city: San Luis Potosi
country: Mexico
facility: Local Institution - 603
state: San Luis Potosí
city: Merida
country: Mexico
facility: Local Institution - 605
state: Yucatán
city: Merida
country: Mexico
facility: Unidad de Atencion Medica e Investigacion en Salud, S.C.
state: Yucatán
city: D.f, Df
country: Mexico
facility: Hospital Angeles Lindavista
city: D.f, Df
country: Mexico
facility: Local Institution - 606
city: Wroclaw
country: Poland
facility: Local Institution - 380
state: Woj. Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Local Institution - 377
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
city: Koscian
country: Poland
facility: Local Institution - 376
city: Koscian
country: Poland
facility: Samodzielny Publiczny Zespól Opieki Zdrowotnej w Koscianie Szpital im. Teodora Dunina
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Local Institution - 375
city: Lublin
country: Poland
facility: Local Institution - 378
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Reumatologii i Ukladowych Chorob Tkanki Laczne
city: Wroclaw
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
city: Kazan
country: Russian Federation
facility: City Clinical Hospital
city: Kazan
country: Russian Federation
facility: Local Institution - 506
city: Kemerovo
country: Russian Federation
facility: Kemerovo State Medical Academy
city: Kemerovo
country: Russian Federation
facility: Local Institution - 505
city: Moscow
country: Russian Federation
facility: Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru
city: Moscow
country: Russian Federation
facility: Local Institution - 507
city: Orenburg
country: Russian Federation
facility: Local Institution - 500
city: Orenburg
country: Russian Federation
facility: Orenburg State Medical Academy
city: St. Petersburg
country: Russian Federation
facility: Saint Petersburg Research Institute for Emergency Medical Care
city: St. Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 502
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 503
city: St. Petersburg
country: Russian Federation
facility: State Higher Educational Institution
city: Vladimir
country: Russian Federation
facility: BioMed, LLC.
city: Vladimir
country: Russian Federation
facility: Local Institution - 504
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy
city: Belgrade
country: Serbia
facility: Institute of Rheumatology Belgrade
city: Belgrade
country: Serbia
facility: Local Institution - 475
city: Belgrade
country: Serbia
facility: Local Institution - 476
city: Belgrade
country: Serbia
facility: Local Institution - 477
city: Belgrade
country: Serbia
facility: Local Institution - 478
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Kragujevac
country: Serbia
facility: Local Institution - 480
city: Niska Banja
country: Serbia
facility: Institute Niska Banja
city: Niska Banja
country: Serbia
facility: Local Institution - 479
city: A Coruña
country: Spain
facility: Hospital Universitario a Coruna
city: A Coruña
country: Spain
facility: Local Institution - 400
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D hebron
city: Barcelona
country: Spain
facility: Local Institution - 403
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
city: Santander
country: Spain
facility: Local Institution - 405
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario Araba - Txagorritxu
Study officials:
affiliation: Celgene Corporation
name: Nataliya Agafonova, MD
role: STUDY_DIRECTOR
References:
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.
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 Jul 12;81(8):1136-1142. doi: 10.1136/annrheumdis-2022-222212.
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.
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.