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

Lupus Erythematosus, Systemic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161483
• Other study ID #: CC-220-SLE-002
• Secondary ID: U1111-1195-7804
• Status: Completed
• Phase: Phase 2
• Start date: August 31, 2017
• Est. completion date: August 3, 2021

Study information

• Verified date: June 2023
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: August 3, 2021
• Est. primary completion date: August 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• CC-220
CC-220

Other:
• Placebo
Placebo QD PO

Locations

Country	Name	City	State
Argentina	Hospital Britanico de Buenos Aires	Buenos Aires
Argentina	Hospital General de Agudos Dr. Jose Maria Ramos Mejia	Buenos Aires
Argentina	Local Institution - 625	Buenos Aires
Argentina	Local Institution - 628	Buenos Aires
Argentina	Organización Médica de Investigación	Buenos Aires
Argentina	Consultora Integral de Salud Centro Médico Privado	Cordoba
Argentina	Hospital Privado Centro Medico de Cordoba	Cordoba
Argentina	Local Institution - 626	Cordoba
Argentina	CER Instituto Mèdico	Quilmes
Argentina	Instituto de Investigaciones Clinicas de Quilmes	Quilmes
Argentina	Local Institution - 629	Quilmes
Argentina	Local Institution - 630	Quilmes
Argentina	Centro Medico Privado de Reumatologia	San Miguel de Tucumán
Argentina	Local Institution - 627	San Miguel de Tucumán
Belgium	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
Brazil	Local Institution - 652	Belo Horizonte
Brazil	Santa Casa de Misericórdia de Belo Horizonte	Belo Horizonte
Brazil	Local Institution - 657	Campinas	São Paulo
Brazil	State University of Campinas UNICAMP	Campinas	São Paulo
Brazil	Centro de Estudos em Terapias Inovadoras LTDA	Curitiba	Paraná
Brazil	Local Institution - 653	Curitiba	Paraná
Brazil	Centro Internacional de Pesquisas	Goiânia	Goiás
Brazil	Local Institution - 655	Goiânia	Goiás
Brazil	LMK Servicos Medicos S/S	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution - 650	Porto Alegre	Rio Grande Do Sul
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
Canada	Local Institution - 205	Calgary	Alberta
Canada	The University of Calgary	Calgary	Alberta
Canada	Local Institution - 201	Hamilton	Ontario
Canada	MAC Research Incorporated	Hamilton	Ontario
Canada	CHUL du CHU de Quebec	Quebec
Canada	Clinique de Rhumatologie Du Centre Du Quebec	Quebec
Canada	Local Institution - 200	Quebec
Canada	Local Institution - 203	Quebec
Canada	Local Institution - 202	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Local Institution - 204	Winnipeg	Manitoba
Canada	University of Manitoba	Winnipeg	Manitoba
Colombia	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	Bogota
Colombia	Idearg S.A.S.	Bogota
Colombia	Local Institution - 676	Bogota
Colombia	Local Institution - 682	Bogota
Colombia	Local Institution - 679	Bucaramanga
Colombia	Medicity S.A.S.	Bucaramanga
Colombia	Servimed S.A.S.	Bucaramanga
Colombia	Local Institution - 677	Chia
Colombia	Preventive Care	Chia
Colombia	Hospital Pablo Tobon Uribe	Medellin
Colombia	Local Institution - 678	Medellin
Colombia	Local Institution - 680	Medellin
Colombia	Reumalab - Centro Integral de Reumatologia	Medellin
France	CHRU de Lille France	Lille Cedex
France	Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere	Paris
France	Local Institution - 326	Paris
France	CHU Hautepierre	Strasbourg
Germany	Local Institution - 302	Kiel
Germany	Universitatsklinikum Schleswig-Holstein	Kiel
Germany	Local Institution - 300	Koeln
Germany	Universitaetsklinikum Koeln	Koeln
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Hungary	Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet	Budapest
Hungary	Local Institution - 350	Budapest
Hungary	Local Institution - 352	Budapest
Hungary	Qualiclinic kft	Budapest
Hungary	Bekes Megyei Kozponti Korhaz	Gyula
Hungary	Local Institution - 351	Gyula
Italy	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
Mexico	Hospital Angeles Lindavista	D.f, Df
Mexico	Local Institution - 606	D.f, Df
Mexico	Centro Integral en Reumatología, S.A. de C.V.	Guadalajara	Jalisco
Mexico	Local Institution - 600	Guadalajara	Jalisco
Mexico	Local Institution - 605	Merida	Yucatán
Mexico	Unidad de Atencion Medica e Investigacion en Salud, S.C.	Merida	Yucatán
Mexico	Centro de Investigacion en Artritis y Osteoporosis	Mexicali	Baja California
Mexico	Local Institution - 610	Mexicali	Baja California
Mexico	Biológicos Especializados S.A. de C.V.	Mexico	Distrito Federal
Mexico	Centro de Investigación y Tratamiento Reumatológico	Mexico	Distrito Federal
Mexico	Clinica Integral de Osteoporosis y Artitis Reumatoide CLINOSAR	Mexico	Distrito Federal
Mexico	Local Institution - 602	Mexico	Distrito Federal
Mexico	Local Institution - 607	Mexico	Distrito Federal
Mexico	Local Institution - 608	Mexico	Distrito Federal
Mexico	Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.	San Luis Potosi	San Luis Potosí
Mexico	Local Institution - 603	San Luis Potosi	San Luis Potosí
Poland	Local Institution - 377	Bydgoszcz
Poland	Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Local Institution - 376	Koscian
Poland	Samodzielny Publiczny Zespól Opieki Zdrowotnej w Koscianie Szpital im. Teodora Dunina	Koscian
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	Local Institution - 380	Wroclaw	Woj. Dolnoslaskie
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.	Wroclaw
Russian Federation	City Clinical Hospital	Kazan
Russian Federation	Local Institution - 506	Kazan
Russian Federation	Kemerovo State Medical Academy	Kemerovo
Russian Federation	Local Institution - 505	Kemerovo
Russian Federation	Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru	Moscow
Russian Federation	Local Institution - 507	Moscow
Russian Federation	Local Institution - 500	Orenburg
Russian Federation	Orenburg State Medical Academy	Orenburg
Russian Federation	Leningrad Regional Clinical Hospital	St. Petersburg
Russian Federation	Local Institution - 502	St. Petersburg
Russian Federation	Local Institution - 503	St. Petersburg
Russian Federation	Saint Petersburg Research Institute for Emergency Medical Care	St. Petersburg
Russian Federation	State Higher Educational Institution	St. Petersburg
Russian Federation	BioMed, LLC.	Vladimir
Russian Federation	Local Institution - 504	Vladimir
Russian Federation	Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy	Voronezh
Serbia	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	Niska Banja
Serbia	Local Institution - 479	Niska Banja
Spain	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	La Laguna
Spain	Hospital Marques de Valdecilla	Santander
Spain	Local Institution - 405	Santander
Spain	Hospital Universitario Araba - Txagorritxu	Vitoria-Gasteiz
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Piedmont Hospital - Atlanta	Atlanta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	University of Maryland - School of Medicine	Baltimore	Maryland
United States	Beth Israel Deaconness Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	DJL Clinical Research	Charlotte	North Carolina
United States	Local Institution - 101	Charlotte	North Carolina
United States	MetroHealth Medical Systems	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Jefrey Lieberman, MD, PC	Decatur	Georgia
United States	Centre For Rheumatology, Immun. And Arthritis	Fort Lauderdale	Florida
United States	Saint Jude Heritage Medical Center	Fullerton	California
United States	University of Florida College of Medicine	Gainesville	Florida
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	Hershey Medical Center	Hershey	Pennsylvania
United States	Local Institution - 136	Hershey	Pennsylvania
United States	Pioneer Research Solutions	Houston	Texas
United States	University of California San Diego Medical Center	La Jolla	California
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	North Georgia Rheumatology	Lawrenceville	Georgia
United States	UCLA Division of Rheumatology	Los Angeles	California
United States	AZ Arthritis and Rheum Rsch, PLLC	Mesa	Arizona
United States	University of Miami	Miami	Florida
United States	Yale University School of Medicine	New Haven	Connecticut
United States	NYU Langone Medical Center	New York	New York
United States	St. Anthony's Medical Center	Oklahoma City	Oklahoma
United States	Desert Medical Advances	Palm Desert	California
United States	University Of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pennsylvania Department of Dermatology	Philadelphia	Pennsylvania
United States	University of Pittsburgh UPMC Lupus Center of Excellence	Pittsburgh	Pennsylvania
United States	Integral Rheumatology and Immunology Specialists	Plantation	Florida
United States	Shanahan Rheumatology and Immunotherapy	Raleigh	North Carolina
United States	C Michael Neuwelt M D	San Leandro	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Clinic of Robert Hozman	Skokie	Illinois
United States	Local Institution - 124	Syracuse	New York
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Bay Care Medical Group	Tampa	Florida
United States	Clinical and Translational Research Center of Alabama, PC	Tuscaloosa	Alabama
United States	Inland Rheumatology Clinical Trials	Upland	California
United States	Advanced Rheumatology & Arthritis Research Center, PC	Wexford	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Colombia,  France,  Germany,  Hungary,  Italy,  Mexico,  Poland,  Russian Federation,  Serbia,  Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The Total Corticosteroid Dose From Baseline Through Week 24	Standardized total oral corticosteroid (OCS) dose.	Through Week 24
Secondary	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

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