A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus... | NCT05620407 | Trialant

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus... | NCT05620407 | 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.

In Japan only: Participants with positive result of β - D-glucan assay.

Other protocol-defined Inclusion/Exclusion criteria apply.

Local Institution - 0063

La Jolla, California 92037, United States

Local Institution - 0241

La Mesa, California 91942, United States

Local Institution - 0242

San Diego, California 92128, United States

Local Institution - 0143

San Leandro, California 94578, United States

Local Institution - 0147

Santa Monica, California 90404, United States

Local Institution - 0213

Clearwater, Florida 33765, United States

Local Institution - 0059

Jacksonville, Florida 32256, United States

Local Institution - 0075

Margate, Florida 33063, United States

Local Institution - 0007

Oakland Park, Florida 33334, United States

Local Institution - 0239

Plant City, Florida 33160, United States

Emory University School of Medicine- Grady Campus

Atlanta, Georgia 30303, United States

Local Institution - 0137

Marietta, Georgia 30060, United States

Local Institution - 0089

Orland Park, Illinois 60467, United States

Local Institution - 0041

Skokie, Illinois 60076, United States

Local Institution - 0231

New Orleans, Louisiana 70112, United States

Local Institution - 0060

Boston, Massachusetts 02114, United States

Local Institution - 0056

Boston, Massachusetts 02215, United States

Local Institution - 0084

Worcester, Massachusetts 01605, United States

Local Institution - 0152

Grand Blanc, Michigan 48439, United States

Local Institution - 0072

Rochester, Minnesota 55905, United States

Local Institution - 0216

Las Vegas, Nevada 89102, United States

Local Institution - 0165

Paramus, New Jersey 07652, United States

Local Institution - 0069

Brooklyn, New York 11201, United States

Local Institution - 0217

Great Neck, New York 11021, United States

Local Institution - 0150

New York, New York 10021, United States

Local Institution - 0102

New York, New York 10032, United States

Local Institution - 0145

Syracuse, New York 13210, United States

Local Institution - 0178

Charlotte, North Carolina 28210, United States

Local Institution - 0005

Cleveland, Ohio 44106, United States

Local Institution - 0043

Oklahoma City, Oklahoma 73104, United States

Local Institution - 0205

Pittsburgh, Pennsylvania 15224, United States

Local Institution - 0081

Charleston, South Carolina 29425, United States

Local Institution - 0225

Florence, South Carolina 29501, United States

Local Institution - 0002

Jackson, Tennessee 38305, United States

Local Institution - 0001

Colleyville, Texas 76034, United States

Local Institution - 0164

El Paso, Texas 79902, United States

Local Institution - 0169

Katy, Texas 77494, United States

Local Institution - 0201

Temple, Texas 76508, United States

Local Institution - 0133

Danville, Virginia 24541, United States

Local Institution - 0146

Ciudad de Buenos Aires, Buenos Aires 1180, Argentina

Local Institution - 0088

La Plata, Buenos Aires 1900, Argentina

Local Institution - 0078

Pergamino, Buenos Aires B2700, Argentina

Local Institution - 0125

Pilar, Buenos Aires 1629, Argentina

Local Institution - 0020

San Juan Bautista, Buenos Aires 1888, Argentina

Local Institution - 0136

San Miguel, Buenos Aires 1663, Argentina

Local Institution - 0018

Quilmes, Buenos Aires F.D. 1879, Argentina

Local Institution - 0013

SAN M. de Tucuman, Tucumán Province T4000AXL, Argentina

Local Institution - 0027

San Miguel de Tucumán, Tucumán Province T4000, Argentina

Local Institution - 0179

Liverpool, New South Wales 2170, Australia

Local Institution - 0182

Parramatta, New South Wales 2150, Australia

Local Institution - 0066

Maroochydore, Queensland 4558, Australia

Local Institution - 0177

Ivanhoe, Victoria 3079, Australia

Local Institution - 0129

Victoria Park, Western Australia 6100, Australia

Local Institution - 0160

Vitória, Espírito Santo 29055450, Brazil

Local Institution - 0028

Lajeado, Rio Grande do Sul 95900-000, Brazil

Local Institution - 0154

Porto Alegre, Rio Grande do Sul 90035-903, Brazil

Local Institution - 0023

Porto Alegre, Rio Grande do Sul 90560032, Brazil

Local Institution - 0230

Porto Velho, Rondônia 76801-098, Brazil

Local Institution - 0175

Barretos, São Paulo 14784400, Brazil

Local Institution - 0115

São Bernardo do Campo, São Paulo 09715-090, Brazil

Local Institution - 0087

Rio de Janeiro, 22061-080, Brazil

Local Institution - 0161

São Paulo, 01327-001, Brazil

Local Institution - 0062

São Paulo, 01409-901, Brazil

Local Institution - 0190

São Paulo, 04266-010, Brazil

Local Institution - 0163

Sofia, Sofia (stolitsa) 1463, Bulgaria

Local Institution - 0158

Plovdiv, 4001, Bulgaria

Local Institution - 0159

Rousse, 7002, Bulgaria

Local Institution - 0139

La Serena, Coquimbo Region 1720430, Chile

Local Institution - 0220

Santiago, Santiago Metropolitan 7500571, Chile

Local Institution - 0101

Santiago, Santiago Metropolitan 7500710, Chile

Local Institution - 0183

Santiago, Santiago Metropolitan 7501126, Chile

Local Institution - 0140

Santiago, Santiago Metropolitan 8330032, Chile

Local Institution - 0203

Santiago, Santiago Metropolitan 8380465, Chile

Local Institution - 0153

Santiago, 7550000, Chile

Local Institution - 0174

Ostrava, Ostrava Město 70300, Czechia

Local Institution - 0036

Prague, 12850, Czechia

Local Institution - 0123

Athens, Attikí (Region) 115 27, Greece

Local Institution - 0116

Athens, Attikí 11527, Greece

Local Institution - 0138

Larissa, Thessalía 411 10, Greece

Local Institution - 0057

Pécs, Baranya 7632, Hungary

Local Institution - 0035

Gyula, Bekes County 5700, Hungary

Local Institution - 0134

Szeged, Csongrád megye 6725, Hungary

Local Institution - 0034

Veszprém, Veszprém City 8200, Hungary

Local Institution - 0234

Ahmedabad, Gujarat 380013, India

Local Institution - 0233

Ahmedabad, Gujarat 382443, India

Local Institution - 0191

Hubli, Karnataka 580021, India

Local Institution - 0222

Mysore, Karnataka 570004, India

Local Institution - 0229

Nagpur, Maharashtra 440012, India

Local Institution - 0210

Vellore, Tamil Nadu 632 004, India

Local Institution - 0235

Hyderabad, Telangana 500016, India

Local Institution - 0199

Secundarabad, Telangana 500003, India

Local Institution - 0053

Nagoya, Aichi-ken 457-8511, Japan

Local Institution - 0156

Nagoya, Aichi-ken 466-8560, Japan

Local Institution - 0083

Toyoake, Aichi-ken 470-1192, Japan

Local Institution - 0047

Chiba, Chiba 260-8712, Japan

Local Institution - 0086

Eiheiji-cho,Yoshida-gun, Fukui 910-1193, Japan

Local Institution - 0117

Kitakyushu, Fukuoka 807-8556, Japan

Local Institution - 0082

Asahikawa, Hokkaido 0708644, Japan

Local Institution - 0048

Sapporo, Hokkaido 0608648, Japan

Local Institution - 0162

Kita, Kagawa-ken 761-0701, Japan

Local Institution - 0111

Sagamihara, Kanagawa 252-0375, Japan

Local Institution - 0157

Yokohama, Kanagawa 236-0004, Japan

Local Institution - 0021

Sendai, Miyagi 980-8574, Japan

Local Institution - 0113

Sasebo, Nagasaki 8571195, Japan

Local Institution - 0022

Kawagoe, Saitama 350-8550, Japan

Local Institution - 0171

Shimotsuga, Tochigi 321-0293, Japan

Local Institution - 0173

Bunkyo-ku, Tokyo 113-8519, Japan

Local Institution - 0046

Bunkyo-ku, Tokyo 1138431, Japan

Local Institution - 0045

Meguro-ku, Tokyo 1538515, Japan

Local Institution - 0064

Shinjyuku-ku, Tokyo 162-8655, Japan

Local Institution - 0226

Toyoma, Toyama 930-0194, Japan

Local Institution - 0227

Fukuoka, 812-8582, Japan

Local Institution - 0050

Fukushima, 960-1295, Japan

Local Institution - 0167

Gifu, 501-1112, Japan

Local Institution - 0126

Nagasaki, 852-8501, Japan

Local Institution - 0131

Niigata, 951-8520, Japan

Local Institution - 0085

Okayama, 700-8558, Japan

Local Institution - 0108

Osaka, 545-8586, Japan

Local Institution - 0054

Tokyo, 104-8560, Japan

Local Institution - 0051

Tokyo, 1608582, Japan

Local Institution - 0148

Wakayama, 641-8510, Japan

Local Institution - 0107

Torreón, Coahuila 27000, Mexico

Local Institution - 0009

León, Guanajuato 37160, Mexico

Local Institution - 0077

Guadajalara, Jalisco 44600, Mexico

Local Institution - 0026

Zapopan, Jalisco 45070, Mexico

Local Institution - 0024

Mexico City, Mexico City 03100, Mexico

Local Institution - 0011

Mexico City, Mexico City 06760, Mexico

Local Institution - 0010

Cuernavaca, Morelos 62290, Mexico

Local Institution - 0124

Monterrey, Nuevo León 64020, Mexico

Local Institution - 0106

Chihuahua City, 31350, Mexico

Local Institution - 0074

Oaxaca City, 68000, Mexico

Local Institution - 0208

Lima, 15046, Peru

Local Institution - 0176

Lima, 15072, Peru

Local Institution - 0118

Lima, 15419, Peru

Local Institution - 0121

Lima, LIMA 31, Peru

Local Institution - 0017

Poznan, Greater Poland Voivodeship 61-545, Poland

Local Institution - 0029

Krakow, Lesser Poland Voivodeship 30-727, Poland

Local Institution - 0186

Lublin, Lublin Voivodeship 20-607, Poland

Local Institution - 0219

Warsaw, Masovian Voivodeship 02-665, Poland

Local Institution - 0185

Warsaw, Masovian Voivodeship 02-672, Poland

Local Institution - 0119

Warsaw, Masovian Voivodeship 03-291, Poland

Local Institution - 0224

Chorzów, Silesian Voivodeship 41-500, Poland

Local Institution - 0016

Elblag, Warmian-Masurian Voivodeship 82-300, Poland

Local Institution - 0071

Szczecin, 71-252, Poland

Local Institution - 0014

Warsaw, 00-874, Poland

Local Institution - 0031

Wroclaw, 52-416, Poland

Local Institution - 0187

Lodz, Łódź Voivodeship 90-368, Poland

Local Institution - 0105

Lisbon, Lisbon District 1649-035, Portugal

Local Institution - 0109

Vila Nova de Gaia, Porto District 4434-502, Portugal

Local Institution - 0144

Lisbon, 1050-034, Portugal

Local Institution - 0073

Lisbon, 2720-276, Portugal

Local Institution - 0240

Caguas, 00725, Puerto Rico

Local Institution - 0194

San Juan, 00909, Puerto Rico

Local Institution - 0135

Singapore, 169608, Singapore

Local Institution - 0127

Singapore, 529889, Singapore

Local Institution - 0151

Mérida, Badajoz 06800, Spain

Local Institution - 0038

Barcelona, Barcelona [Barcelona] 08035, Spain

Local Institution - 0110

Bilbao, Basque Country 48013, Spain

Local Institution - 0061

Santander, Cantabria 39008, Spain

Local Institution - 0103

Cordoba, Madrid 14004, Spain

Local Institution - 0052

Seville, 41010, Spain

Local Institution - 0058

Valencia, 46026, Spain

Local Institution - 0067

Valladolid, 47012, Spain

Local Institution - 0094

Kaohsiung Niao Sung Dist, Kaohsiung 83301, Taiwan

Local Institution - 0040

Taichung, Taichung 402, Taiwan

Local Institution - 0065

Taichung, 404332, Taiwan

Local Institution - 0114

Taichung, 407, Taiwan

Local Institution - 0039

Tainan, 71004, Taiwan

Local Institution - 0181

Taipei, 10002, Taiwan

Local Institution - 0122

Taipei, 11217, Taiwan

Local Institution - 0212

Bangkok, Bangkok 10400, Thailand

Local Institution - 0211

Bangkok, Bangkok 10700, Thailand

Local Institution - 0184

Ankara, 06230, Turkey (Türkiye)

Local Institution - 0166

Antalya, 07059, Turkey (Türkiye)

Local Institution - 0188

Gaziantep, 27090, Turkey (Türkiye)

Local Institution - 0223

London, England NW32QG, United Kingdom

Local Institution - 0090

London, Greater London SE5 9RS, United Kingdom

Local Institution - 0091

London, London, City of SE1 9RT, United Kingdom

Local Institution - 0168

Central Middlesbrough, Middlesbrough TS4 3BW, United Kingdom

Local Institution - 0130

Oxford, OX3 7LD, United Kingdom