A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03517722
• Other study ID #: CR108440
• Secondary ID: 2017-001489-53CN
• Status: Terminated
• Phase: Phase 3
• Start date: April 16, 2018
• Est. completion date: November 5, 2020

Study information

• Verified date: December 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.

Description:

This study evaluates the efficacy, safety, and tolerability of ustekinumab in participants with active SLE according to Systemic Lupus International Collaborating Clinics (SLICC) criteria Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than (>=) 6, despite receiving one or more standard-of-care treatments (example, immunomodulators, antimalarial drugs, and/or glucocorticoids). The total duration of the study is up to 182 weeks, consisting of 3 study periods: a screening period (approximately 6 weeks), a double blind period (52 weeks), and an extension period (124 weeks). Other study evaluations will include pharmacokinetics, immunogenicity, biomarkers and pharmacogenomic evaluations. The safety of the participants enrolled in the study will be monitored on an ongoing basis throughout the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 516
• Est. completion date: November 5, 2020
• Est. primary completion date: November 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• Be male or female
• Has a documented medical history (that is, met at least 1 of the two criteria below) that participant met the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for systemic lupus erythematosus (SLE) at least 3 months prior

to first dose of study agent:

1. Met a total of at least 4 SLICC criteria, including at least 1 clinical and at least 1 immunologic;

2. Has a diagnosis of lupus nephritis, confirmed by renal biopsy and at least 1 of the following autoantibodies: antinuclear antibodies (ANA) or anti-double-stranded deoxyribonucleic acid (anti-dsDNA)

• Has a positive test in the medical history and confirmed at screening for at least 1 of the following autoantibodies: antinuclear antibodies, anti-double-stranded deoxyribonucleic acid, and/or anti-Smith
• Has greater than or equal to (>=) 1 British Isles Lupus Assessment Group (BILAG) A and/or >= 2 BILAG B scores observed during screening
• Has a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score >=4 (excluding diffuse non-inflammatory alopecia) or >= 4 joints with pain and signs of inflammation at screening, Week 0, or both
• Has a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score >=6 at screening. Must also have SLEDAI-2K >= 4 for clinical features (excluding headache and laboratory abnormalities) at Week 0
• Cannot be pregnant, nursing, intending to become pregnant, or unwilling to follow contraception or egg/sperm donation guidelines
• Must be receiving stable doses of >=1 protocol-permitted standard of care SLE treatment: oral glucocorticoids, anti-malarials, immunomodulators (methotrexate, azathioprine, 6-mercaptopurine, mycophenolate mofetil, mycophenolic acid)

Exclusion Criteria:

• Has any unstable or progressive SLE manifestation (example: central nervous system lupus, systemic vasculitis, end-stage renal disease, severe or rapidly progressive glomerulonephritis, pulmonary hemorrhage, myocarditis) that may warrant escalation in therapy beyond permitted background medications. Participants requiring renal hemodialysis or peritoneal dialysis are also excluded
• Has other co-existent inflammatory diseases (example: rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn's disease)
• Has a urinary protein to creatinine ratio of greater than (>)4 gram per gram (g/g) per day
• Has an acute or chronic infectious illness (example: human immunodeficiency virus, hepatitis B or C virus, tuberculosis, opportunistic infections)
• Has a history of cancer or lymphoproliferative disease within the last 5 years except for treated and non-recurrent cutaneous basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma
• Has any condition requiring multiple courses of systemic glucocorticoids (example:

uncontrolled asthma, chronic obstructive pulmonary disease)

• Has a history of major surgery within the last month
• Has received live virus or bacterial vaccines within 16 weeks prior to first dose of study agent or Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening
• Has previously received ustekinumab
• Has received cyclophosphamide orally within 90 days or intravenously within 180 days of screening
• Has received a single B-cell targeted therapy (e.g. belimumab) within 3 months, >1 previous B-cell targeted therapy within 6 months, or B-cell depleting therapy (example: rituximab) within 12 months of first dose of study agent
• Has received protocol-prohibited oral or biologic immunomodulatory therapy in the last 3 months or less than (<)5 half-lives (whichever is longer) prior to first dose of study agent
• Has received adrenocorticotropic hormone (ACTH) within 1 month prior to first dose of study agent
• Has received epidural, intravenous, intramuscular, intraarticular, intrabursal, intralesional glucocorticoids within 6 weeks of first dose of study agent
• Locally-delivered therapies except for ophthalmic use of cyclosporine A or topical use of nonsteroidal anti inflammatory drugs (NSAIDs), analgesics, or high-potency glucocorticoids (World Health Organization criteria) are prohibited

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• Placebo
Participants will receive placebo matching to ustekinumab IV or SC.
• Ustekinumab (approximately 6 mg/kg)
Participants will receive ustekinumab approximately 6 mg/kg via IV route based on body weight-range.
• Ustekinumab 90 mg
Participants will receive 90 mg ustekinumab via SC route.

Locations

Country	Name	City	State
Argentina	Centro Privado de Medicina Familiar	Buenos Aires
Argentina	Fundacion CENIT para la Investigacion en Neurociencias	Buenos Aires
Argentina	Instituto Centenario	Buenos Aires
Argentina	Framingham Centro Medico	Ciudad De La Plata
Argentina	Hospital Italiano de Cordoba	Cordoba
Argentina	Hospital Escuela 'Gral. Jose F. de San Martin'	Corrientes
Argentina	CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica	San Juan
Argentina	Centro Medico Privado de Reumatologia	San Miguel de Tucumán
Bulgaria	MHAT Trimantium	Plovdiv
Bulgaria	Diagnostic-Consultative Center (DCC) Aleksandrovska	Sofia
Bulgaria	Medical Centre Synexus	Sofia
Bulgaria	UMHAT St. Ivan Rilski	Sofia
Canada	University of Calgary	Calgary	Alberta
Canada	McMaster University	Hamilton	Ontario
Canada	CHU de Québec	Quebec
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	University of Manitoba	Winnipeg	Manitoba
China	The First Affiliated Hospital of Baotou Medical University	Baotou
China	Peking Union Medical College Hospital	Beijing
China	West China Hospital, Sichuan University	Chengdu
China	Guangdong Provincial People's Hospital	Guangzhou
China	Affiliated Hospital of Inner Mongolia Med U	Hohhot
China	Shanghai Ruijin Hospital	Shanghai
China	Tianjin Medical University General Hospital	Tianjin
China	Tongji Hospital of Tongji Medical College of Huangzhong Univ	Wuhan
China	The 1st affiliated Hospital of Xi'an Traffic University	Xi'an
Colombia	Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.	Bogotá
Colombia	IPS Medicity SAS	Bucaramanga
Colombia	Servimed S.A.S	Bucaramanga
Colombia	Preventive Care Ltda	Chia
Colombia	Clinica Universitaria Bolivariana	Medellin
Colombia	Funcentra	Montería
Germany	Charite - Universitaetsmedizin Berlin (CCM)	Berlin
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Rheumazentrum Ruhrgebiet	Herne
Germany	Rheumatology Unit	Leipzig
Germany	Universitaetsmedizin Mainz	Mainz
Hungary	Szt, Istvan and Szt. Laszlo	Budapest
Hungary	Bekes Megyei Pandy Kalman Korhaz	Gyula
Hungary	Belvarosi Egeszseghaz Kft. (Leda-Platan Maganklinika es Sebeszeti Kozpont)	Zalaegerszeg
Japan	Chiba University Hospital	Chiba
Japan	National Hospital Organization Chibahigashi National Hospital	Chiba
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital	Hiroshima
Japan	Hospital of the University of Occupational and Environmental Health	Hukuoka
Japan	National Hospital Organization Osaka Minami Medical Center	Kawachi-Nagano
Japan	Kawasaki Rheumatism and Internal Medicine Clinic	Kitakyushu
Japan	Toho University Medical Center, Ohashi Hospital	Meguro-ku
Japan	Nagasaki University Hospital	Nagasaki-shi
Japan	National Hospital Organization Nagoya Medical Center	Nagoya
Japan	Kitasato University Hospital	Sagamihara
Japan	Sapporo City General Hospital	Sapporo
Japan	Hokkaido University Hospital	Sapporo-shi
Japan	Sasebo Chuo Hospital	Sasebo
Japan	Tohoku University Hospital	Sendai-shi
Japan	Keio University Hospital	Shinjuku-ku
Japan	National Center for Global Health and Medicine	Shinjuku-ku
Japan	Juntendo University Hospital	Tokyo
Japan	St. Luke's International Hospital	Tokyo
Japan	Fujita Health University Hospital	Toyoake
Japan	National Hospital Organization Yokohama Medical Center	Yokohama
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Chonbuk National Univ Hospital	JeonJu
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Lithuania	Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik	Kaunas
Lithuania	Klaipeda University Hospital	Klaipeda
Lithuania	Vaiku ligonine Vilniaus Universiteto ligon. Santariskiu fil	Vilnius
Lithuania	Vilnius University Hospital Santariskiu Clinics	Vilnius
Poland	Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Nzoz Bif-Med	Bytom
Poland	Centrum Medyczne AMED oddzial w Lodzi	Lodz
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie	Lublin
Poland	Twoja Przychodnia - Centrum Medyczne Nowa Sol	Nowa Sol
Poland	Centrum Medyczne Medens S.C. Grupowa Praktyka Lekarska	Sonoswiec
Poland	Centrum Medyczne Pratia Tychy	Tychy
Poland	Centrum Medyczne Pratia Warszawa	Warszawa
Poland	Reumatika-Centrum Reumatologii, NZOZ	Warszawa
Poland	Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego	Wroclaw
Portugal	Hospital Curry Cabral-Centro Hospital Lisboa Central	Lisboa
Portugal	Hospital da Luz	Lisboa
Portugal	Instituto Portugues de Reumatologia	Lisboa
Portugal	ULSAM, EPE - Hospital Conde de Bertiandos	Ponte de Lima
Portugal	C.H. de Vila Nova de Gaia/Espinho	Vila Nova de Gaia
Russian Federation	LLL Medical Center Revma-Med	Kemerovo
Russian Federation	Regional Clinical Hospital for War Veterans	Kemerovo
Russian Federation	Clinical Diagnostic Center 'Ultramed'	Omsk
Russian Federation	Leningrad region clinical hospital	Saint-Petersburg
Russian Federation	City Clinical Hospital #31	St. Petersburg
Russian Federation	Northen-Western State Medical University n.a. I.I. Mechnikov	St.-Petersburg
Russian Federation	Ulyanovsk Regional Clinical Hospital	Ulyanovsk
Russian Federation	Clinical Emergency Hospital n.a. N.V. Solovyev	Yaroslavl
Serbia	Clinical Hospital Center Bezanijska Kosa	Belgrade
Serbia	Institute of Rheumatology	Belgrade
Serbia	Institute of Rheumatology Belgrade	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	University Clinical Center Kragujevac	Kragujevac
Serbia	Institute for Treatment and Rehabilitation Niska Banja	Niska Banja
Serbia	Clinical Center of Vojvodina	Vojvodina
South Africa	Panorama Medical Centre	Cape Town
South Africa	Excellentis Clinical trial Consultants	George
South Africa	Clinical Research Unit, University of Pretoria	Pretoria
South Africa	Winelands Medical Research Centre	Stellenbosch
Spain	Hosp. Univ. Vall D Hebron	Barcelona
Spain	Hosp. Univ. de Basurto	Bilbao
Spain	Hosp. Reina Sofia	Cordoba
Spain	Hosp. Clinico San Carlos	Madrid
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Regional Univ. de Malaga	Málaga
Spain	Hosp. Univ. Infanta Sofia	San Sebastián de los Reyes
Spain	Hosp. Infanta Luisa	Sevilla
Spain	Hosp. Do Meixoeiro	Vigo -Pontevedra
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Chang Gung Memorial Hospital	Kwei-san Hsiang
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Cathay General Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Medical University	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Thailand	Phramongkutklao Hospital and Medical College	Bangkok
Thailand	Rajavhiti Hospital	Bangkok
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Songklanagarind hospital	Hat Yai
Thailand	Chiang Mai University	Muang
Ukraine	Mechnikov Inst, Miska bagatoprofilna likarnia #18	Kharkiv
Ukraine	Kyiv City Clinical Hospital #3	Kyiv
Ukraine	Kyivska oblasna klinichna likarnia	Kyiv
Ukraine	Odeska oblasna klinichna likarnia	Odesa
Ukraine	Multidisciplinary Medical Center of Odessa National Medical University	Odessa
Ukraine	MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'	Vinnytsia
Ukraine	Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]	Vinnytsia
United States	Albuquerque Center for Rheumatology	Albuquerque	New Mexico
United States	Amarillo Center for Clinical Research	Amarillo	Texas
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Emory University	Atlanta	Georgia
United States	Piedmont Healthcare - Piedmont Hospital	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Austin Regional Clinic	Austin	Texas
United States	Arthritis and Rheumatic Disease Specialties	Aventura	Florida
United States	Rheumatology & Pulmonary Clinic	Beckley	West Virginia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Graves-Gilbert Clinic - Bowling Green	Bowling Green	Kentucky
United States	Bay Area Arthritis and Osteoporosis	Brandon	Florida
United States	DJL Clinical Research, PLLC	Charlotte	North Carolina
United States	Joint and Muscle Research Institute	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Columbia Arthritis Center	Columbia	South Carolina
United States	Medvin Clinical Research	Covina	California
United States	Arthritis Centers of Texas	Dallas	Texas
United States	DeKalb Medical Specialty Center	Decatur	Georgia
United States	Denver Arthritis Clinic	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	St Paul Rheumatology PA	Eagan	Minnesota
United States	Centre for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida
United States	Lugene Eye Institute	Glendale	California
United States	C.V. Mehta, MD Medical Corp.	Hemet	California
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	University of Florida Health Jacksonville	Jacksonville	Florida
United States	University of California at San Diego	La Jolla	California
United States	Biomedical Research Alliance Of New York	Lake Success	New York
United States	Advanced Medical Research - Lakewood	Lakewood	California
United States	June DO, PC.	Lansing	Michigan
United States	Innovative Health Research	Las Vegas	Nevada
United States	Oklahoma Medical Research Foundation	Las Vegas	Nevada
United States	Loma Linda University	Loma Linda	California
United States	Loma Linda University Health Care	Loma Linda	California
United States	Valerius Medical Group & Research Center	Los Alamitos	California
United States	Keck School of Medicine of USC	Los Angeles	California
United States	Wallace Rheumatic Study Center	Los Angeles	California
United States	The Feinstein Institute for Medical Research	Manhasset	New York
United States	Dr. Ramesh Gupta	Memphis	Tennessee
United States	New Horizon Research Center	Miami	Florida
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Arthritis and Diabetes Clinic	Monroe	Louisiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	UPMC Lupus Center of Excellence	New Haven	Connecticut
United States	Hospital for Special Surgery	New York	New York
United States	NYU Center for Musculoskeletal Care	New York	New York
United States	Omega Research Consultants	Orlando	Florida
United States	Rheumatology Associates of Central Florida, PA	Orlando	Florida
United States	Millennium Research	Ormond Beach	Florida
United States	Lewis Katz School of Medicine, Temple University	Philadelphia	Pennsylvania
United States	Integral Rheumatology & Immunology Specialists	Plantation	Florida
United States	Sun Research Institute	San Antonio	Texas
United States	UT Health Science Center at San Antonio	San Antonio	Texas
United States	East Bay Rheumatology Medical Group	San Leandro	California
United States	University of Washington	Seattle	Washington
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Clinical Research of West Florida	Tampa	Florida
United States	Westlake Medical Research Clinical Trials	Thousand Oaks	California
United States	OK Center for Arthritis Therapy & Research, Inc.	Tulsa	Oklahoma
United States	University Clinical Investigators, Inc	Tustin	California
United States	Inland Rheumatology Clinical Trials Inc.	Upland	California
United States	Achieve Clinical Research, LLC	Vestavia Hills	Alabama
United States	Allegheny Rheumatology/Allegheny Singer Research Institute	Wexford	Pennsylvania
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Canada,  China,  Colombia,  Germany,  Hungary,  Japan,  Korea, Republic of,  Lithuania,  Poland,  Portugal,  Russian Federation,  Serbia,  South Africa,  Spain,  Taiwan,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52	SRI-4 response:>=4-point reduction in SLEDAI-2K total score, no British Isles Lupus Assessment Group (BILAG) A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (<10 % increase)from baseline in Physician's Global Assessment(PGA).SLEDAI measures disease activity in 9 organ systems,higher scores=more severe disease activity.Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).	Week 52
Secondary	Time to First Flare	Time to flare is defined as the time (in days) post baseline when the first flare occurs. It was calculated with flare defined as either 1 or more BILAG A (severe disease activity) or 2 or more new BILAG B (moderate disease activity) domain scores relative to baseline. BILAG was defined as a measure of alterations or intensification to therapy consisting of 97 questions in 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. BILAG A flare was defined as at least 1 new BILAG A scores. BILAG B flare was defined as at least 2 new BILAG B scores.	Up to Week 52
Secondary	Percentage of Participants With an SRI-4 Composite Response at Week 24	SRI-4 response:>=4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no BILAG A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (<10 % increase)from baseline in PGA.SLEDAI measures disease activity in 9 organ systems, higher scores=more severe disease activity. Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).	Week 24
Secondary	Percentage of Participants With 50 Percent (%) Improvement in Joints With Pain and Signs of Inflammation (Active Joints) at Week 52	The percentage of participants who achieved at least 50% improvement from baseline in number of joints with pain and signs of inflammation at Week 52 for participants with at least 4 joints with pain and signs of inflammation at baseline were reported.	Week 52
Secondary	Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40 and Sustain That Change Through Week 52	Reduction of glucocorticoid dose was defined as a reduction in average daily oral glucocorticoid dose by at least 50% (relative to the baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to the baseline dose) so that the average daily dose was reduced to less than or equal to (<=) 7.5 milligram (mg) (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who, at baseline, were receiving oral glucocorticoids.	Up to Week 52
Secondary	Percentage of Participants With at Least a 50% Improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 52	Percentage of participants achieving at least 50% improvement in CLASI activity score at Week 52 reported in participants with a CLASI activity score of 4 or greater at baseline. The CLASI is an instrument to assess the disease activity and damage caused to the skin for cutaneous lupus erythematosus participants with or without systemic involvement. The CLASI activity score ranges from 0-70 with lower score being improved. Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia.	Week 52
Secondary	Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40, Sustained That Change Through Week 52, and Achieved an SRI-4 Composite Response at Week 52	Percentage of participants with reduction in glucocorticoid dose by Week 40, its sustenance through Week 52, and SRI 4 composite response at Week 52 were reported. Reduction of glucocorticoid dose was defined as reduction in average daily oral glucocorticoid dose by at least 50% (relative to baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to baseline dose) so that average daily dose is reduced to <=7.5 mg (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who,at baseline,were receiving oral glucocorticoids. SRI-4 was defined as composite of at least 4-point improvement in SLEDAI-2K score of 0=no symptoms to 105=presence of all defined symptoms with higher scores representing increased disease activity),no worsening in BILAG and no worsening in PGA.	Up to Week 52

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