A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) | NCT05617677 | Trialant

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) | NCT05617677 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria

Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit.

Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.

One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening.

Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash.

Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry.

At least one SLE background therapy (immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation.

Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant.

Exclusion Criteria

Diagnosis of drug-induced SLE rather than idiopathic SLE.

Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded.

SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded.

Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria.

Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS.

History of congenital or acquired immunodeficiency.

Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization.

Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria).

Taking more than 1 immunosuppressant at screening.

Other protocol-defined Inclusion/Exclusion criteria apply.

Local Institution - 0012

Birmingham, Alabama 35205, United States

Local Institution - 0229

Phoenix, Arizona 85006, United States

Local Institution - 0193

Tucson, Arizona 85724, United States

Kaiser Permanente

Fontana, California 92335, United States

Local Institution - 0247

La Mesa, California 91942, United States

Local Institution - 0090

La Palma, California 90623, United States

Local Institution - 0124

Los Angeles, California 90095, United States

Local Institution - 0248

Sacramento, California 95817, United States

Local Institution - 0253

San Diego, California 92128, United States

Local Institution - 0128

Santa Barbara, California 93108, United States

Local Institution - 0099

Denver, Colorado 80230, United States

Local Institution - 0054

New Haven, Connecticut 06510, United States

Local Institution - 0249

Coral Springs, Florida 33065, United States

Local Institution - 0010

Gainesville, Florida 32610, United States

Local Institution - 0087

Miami, Florida 33136, United States

Local Institution - 0007

Orlando, Florida 32806, United States

Local Institution - 0242

Plantation, Florida 33317, United States

Local Institution - 0002

Tamarac, Florida 33321, United States

Local Institution - 0165

Tampa, Florida 33614, United States

Local Institution - 0204

Atlanta, Georgia 30318, United States

Local Institution - 0228

Lawrenceville, Georgia 30044, United States

Local Institution - 0147

Lawrenceville, Georgia 30046, United States

Local Institution - 0227

Morton Grove, Illinois 60053, United States

Local Institution - 0077

Schaumburg, Illinois 60195, United States

Local Institution - 0108

Indianapolis, Indiana 46202, United States

Lake Cumberland Rheumatology

New Albany, Indiana 47150, United States

Local Institution - 0225

New Orleans, Louisiana 70121, United States

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Detroit, Michigan 48202, United States

Local Institution - 0179

Eagan, Minnesota 55121, United States

Local Institution - 0177

Summit, New Jersey 07901, United States

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Manhasset, New York 11030, United States

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New York, New York 10016, United States

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Rochester, New York 14642, United States

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The Bronx, New York 10467, United States

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Charlotte, North Carolina 28207, United States

Local Institution - 0155

Charlotte, North Carolina 28211, United States

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Summerville, South Carolina 29486, United States

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Memphis, Tennessee 38119, United States

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Allen, Texas 75013, United States

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Dallas, Texas 75390, United States

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Fort Worth, Texas 76177, United States

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Houston, Texas 77090, United States

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Lubbock, Texas 79415, United States

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The Woodlands, Texas 77382, United States

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Roanoke, Virginia 24016, United States

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Seattle, Washington 98122, United States

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Seattle, Washington 98195, United States

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Franklin, Wisconsin 53132, United States

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Quilmes, Buenos Aires 1878, Argentina

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Buenos Aires, Buenos Aires F.D. C1121ABE, Argentina

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CABA, Buenos Aires F.D. 1406, Argentina

Local Institution - 0123

San Miguel de Tucumán, Tucumán Province 4000, Argentina

Local Institution - 0032

Buenos Aires, 1123, Argentina

Local Institution - 0240

Buenos Aires, C1023AAB, Argentina

Local Institution - 0022

Buenos Aires, C1221ADC, Argentina

Local Institution - 0140

Buenos Aires, CP1280AEB, Argentina

Local Institution - 0138

Córdoba, 5004, Argentina

Local Institution - 0017

Mendoza, 5500, Argentina

Local Institution - 0224

Salvador, Estado de Bahia 40150-150, Brazil

Local Institution - 0096

Lago Sul, Federal District 71635580, Brazil

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Belo Horizonte, Minas Gerais 30150-221, Brazil

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Juiz de Fora, Minas Gerais 36010-570, Brazil

Local Institution - 0190

Curitiba, Paraná 80730-150, Brazil

Local Institution - 0181

Porto Alegre, Rio Grande do Sul 90610000, Brazil

Local Institution - 0185

Campinas, São Paulo 13015-001, Brazil

Local Institution - 0187

Ribeirão Preto, São Paulo 14051-140, Brazil

Local Institution - 0066

São José do Rio Preto, São Paulo 15090000, Brazil

Local Institution - 0191

São Paulo, São Paulo 04038-002, Brazil

Local Institution - 0186

Rio de Janeiro, 20551-030, Brazil

Local Institution - 0125

São Paulo, 05403-000, Brazil

Local Institution - 0163

Plovdiv, 4000, Bulgaria

Local Institution - 0217

Sofia, 1407, Bulgaria

Local Institution - 0162

Sofia, 1784, Bulgaria

Local Institution - 0126

Calgary, Alberta T2N 4N1, Canada

Local Institution - 0160

Hamilton, Ontario L8S 4K1, Canada

Local Institution - 0114

London, Ontario N6A 4V2, Canada

Local Institution - 0115

Toronto, Ontario M5T 2S8, Canada

Local Institution - 0136

Rimouski, Quebec G5L 5T1, Canada

Local Institution - 0110

Bengbu, Anhui 233017, China

Local Institution - 0070

Beijing, Beijing Municipality 100730, China

Local Institution - 0107

Xiamen, Fujian 361003, China

Local Institution - 0029

Guangzhou, Guangdong 510000, China

Local Institution - 0051

Guangzhou, Guangdong 510080, China

Local Institution - 0080

Guangzhou, Guangdong 510120, China

Local Institution - 0037

Shenzhen, Guangdong 518020, China

Local Institution - 0153

Baoding, Hebei 071030, China

Local Institution - 0133

Luoyang, Henan 471003, China

Local Institution - 0023

Zhengzhou, Henan 450000, China

Local Institution - 0137

Wuhan, Hubei 430022, China

Local Institution - 0044

Changsha, Hunan 410008, China

Local Institution - 0021

Zhuzhou, Hunan 412007, China

Local Institution - 0089

Hohhot, Inner Mongolia 010050, China

Local Institution - 0129

Changzhou, Jiangsu 213003, China

Local Institution - 0031

Jiujiang, Jiangxi 332000, China

Local Institution - 0071

Nanchang, Jiangxi 330006, China

Local Institution - 0117

Nanchang, Jiangxi 330006, China

Local Institution - 0220

Nanchang, Jiangxi 330006, China

Local Institution - 0028

Pingxiang, Jiangxi 337055, China

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Shenyang, Liaoning 110001, China

Local Institution - 0092

Shenyang, Liaoning 110004, China

Local Institution - 0149

Jinan, Shandong 250001, China

Local Institution - 0079

Shanghai, Shanghai Municipality 200025, China

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Shanghai, Shanghai Municipality 200040, China

Local Institution - 0049

Shanghai, Shanghai Municipality 200127, China

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Chengdu, Sichuan 610041, China

Local Institution - 0053

Tianjin, Tianjin Municipality 300052, China

Local Institution - 0043

Ürümqi, Xinjiang 830001, China

Local Institution - 0132

Hangzhou, Zhejiang 310003, China

Local Institution - 0135

Wenzhou, Zhejiang 325000, China

Local Institution - 0158

Taiyuan, 030032, China

Local Institution - 0174

Medellín, Antioquia 050021, Colombia

Local Institution - 0056

Barranquilla, Atlántico 080002, Colombia

Local Institution - 0086

Bucaramanga, Santander Department 680003, Colombia

Local Institution - 0100

Bogotá, 110221, Colombia

Local Institution - 0170

Bogotá, 110231, Colombia

Local Institution - 0093

Cali, 760035, Colombia

Local Institution - 0057

Chía, 250001, Colombia

Local Institution - 0150

Strasbourg, Alsace 67091, France

Local Institution - 0068

Nantes, Loire-Atlantique 44093 Cedex 1, France

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Le Kremlin-Bicêtre, 94270, France

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Tours, 37032, France

Local Institution - 0109

Tübingen, Baden-Wurttemberg 72076, Germany

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Munich, Bavaria 80336, Germany

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Dresden, Saxony 01307, Germany

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Lübeck, Schleswig-Holstein 23538, Germany

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Chemnitz, 09117, Germany

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Cologne, 50937, Germany

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Erlangen, 91054, Germany

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Planegg, 82152, Germany

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Tuenmen, 999077, Hong Kong

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Vizianagaram, Andhra Pradesh 0, India

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Ahmedabad, Gujarat 380015, India

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Surat, Gujarat 395010, India

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Gurugram, Haryana 122001, India

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Bengaluru, Karnataka 560010, India

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Hyderabad, Telangana 500038, India

Local Institution - 0205

Hyderabad, Telangana 500082, India

Local Institution - 0119

Manorhamilton, Leitrim 0, Ireland

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Cork, T12 E8YV, Ireland

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Dublin, D08 E9P6, Ireland

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Dublin, D15 X40D, Ireland

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Rome, Lazio 00161, Italy

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Milan, Lombardy 20122, Italy

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Pisa, Tuscany 56126, Italy

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Padova, Veneto 35128, Italy

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Brescia, 25123, Italy

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Milan, 20132, Italy

Local Institution - 0154

Naples, 80131, Italy

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Verona, 37134, Italy

Local Institution - 0167

Kaunas, Kaunas County LT-50161, Lithuania

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Mexicali, Estado de Baja California 21100, Mexico

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León, Guanajuato 37000, Mexico

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Zapopan, Jalisco 45116, Mexico

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Mexico City, Mexico City 01120, Mexico

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Mexico City, Mexico City 03720, Mexico

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Mexico City, Mexico City 06700, Mexico

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Mexico City, Mexico City 06700, Mexico

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Mexico City, Mexico City 14080, Mexico

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Chihuahua City, 31000, Mexico

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Puebla City, 72160, Mexico

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Chisinau, Chișinău MD-2051, Moldova

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Chisinau, 2025, Moldova

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Arequipa, 05154, Peru

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Lima, 15046, Peru

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Lima, 15047, Peru

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Lima, 33, Peru

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Poznan, Greater Poland Voivodeship 60-218, Poland

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Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168, Poland

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Krakow, Lesser Poland Voivodeship 30-363, Poland

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Nadarzyn, Masovian Voivodeship 05-830, Poland

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Warsaw, Masovian Voivodeship 02-118, Poland

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Warsaw, Masovian Voivodeship 02-637, Poland

Local Institution - 0047

Katowice, Silesian Voivodeship 40-081, Poland

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Bialystok, 15-707, Poland

Velocity Clinical Research, Lublin

Lublin, 20-362, Poland

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Poznan, 60-702, Poland

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Bełchatów, Łódź Voivodeship 97-400, Poland

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Caguas, 00725, Puerto Rico

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San Juan, 00909, Puerto Rico

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San Juan, 00917, Puerto Rico

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Bucharest, Bucharest 011053, Romania

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Bucharest, Bucharest 011172, Romania

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Bucharest, Bucharest 014142, Romania

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Bucharest, Bucharest 020125, Romania

Local Institution - 0215

Bucharest, Bucharest 041303, Romania

Local Institution - 0210

Bucharest, Bucharest 30463, Romania

Local Institution - 0142

Craiova, Dolj 200347, Romania

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Iași, Iaşi 700127, Romania

Local Institution - 0094

Râmnicu Vâlcea, Vâlcea County 247065, Romania

Local Institution - 0143

Timișoara, 300766, Romania

Local Institution - 0102

Gwangju, Kwangju-Kwangyǒkshi 61469, South Korea

Local Institution - 0101

Suwon, Kyǒnggi-do 16499, South Korea

Local Institution - 0144

Seoul, Seoul-teukbyeolsi [Seoul] 06591, South Korea

Local Institution - 0169

Seoul, 04763, South Korea

Local Institution - 0184

Ankara, 06560, Turkey (Türkiye)

Local Institution - 0168

Istanbul, 34098, Turkey (Türkiye)

Local Institution - 0189

Kocaeli, 41380, Turkey (Türkiye)