New pill could tame lupus flares

NCT ID NCT05617677

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether the oral drug deucravacitinib can safely control moderate to severe lupus better than a placebo. About 516 adults with active lupus are taking either the drug or a dummy pill for several months. The goal is to see if the drug reduces lupus symptoms and flares.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Deucravacitinib
What this could lead to: If successful, this could provide a new oral treatment option for people with active lupus, helping to control disease activity and reduce symptoms.
What could go wrong: This is a Phase 3 trial, but results are not yet available. Deucravacitinib may not prove more effective than placebo, and side effects are possible. It is not a cure, and patients may still need ongoing medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

516 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autoimmune disease connective tissue disorder immune system disorder systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

Contacts and locations

Locations

Kaiser Permanente

Fontana, California, 92335, United States
Lake Cumberland Rheumatology

New Albany, Indiana, 47150, United States
Local Institution - 0002

Tamarac, Florida, 33321, United States
Local Institution - 0003

Memphis, Tennessee, 38119, United States
Local Institution - 0005

The Woodlands, Texas, 77382, United States
Local Institution - 0006

Detroit, Michigan, 48202, United States
Local Institution - 0007

Orlando, Florida, 32806, United States
Local Institution - 0009

Roanoke, Virginia, 24016, United States
Local Institution - 0010

Gainesville, Florida, 32610, United States
Local Institution - 0011

Seattle, Washington, 98122, United States
Local Institution - 0012

Birmingham, Alabama, 35205, United States
Local Institution - 0013

Buenos Aires, Buenos Aires F.D., C1121ABE, Argentina
Local Institution - 0015

Mexicali, Estado de Baja California, 21100, Mexico
Local Institution - 0016

Mexico City, Mexico City, 06700, Mexico
Local Institution - 0017

Mendoza, 5500, Argentina
Local Institution - 0018

Chihuahua City, 31000, Mexico
Local Institution - 0020

CABA, Buenos Aires F.D., 1406, Argentina
Local Institution - 0021

Zhuzhou, Hunan, 412007, China
Local Institution - 0022

Buenos Aires, C1221ADC, Argentina
Local Institution - 0023

Zhengzhou, Henan, 450000, China
Local Institution - 0024

Zapopan, Jalisco, 45116, Mexico
Local Institution - 0026

Mexico City, Mexico City, 01120, Mexico
Local Institution - 0027

Mexico City, Mexico City, 03720, Mexico
Local Institution - 0028

Pingxiang, Jiangxi, 337055, China
Local Institution - 0029

Guangzhou, Guangdong, 510000, China
Local Institution - 0031

Jiujiang, Jiangxi, 332000, China
Local Institution - 0032

Buenos Aires, 1123, Argentina
Local Institution - 0033

Krakow, Lesser Poland Voivodeship, 30-363, Poland
Local Institution - 0034

Nadarzyn, Masovian Voivodeship, 05-830, Poland
Local Institution - 0035

Bialystok, 15-707, Poland
Local Institution - 0036

Poznan, Greater Poland Voivodeship, 60-218, Poland
Local Institution - 0037

Shenzhen, Guangdong, 518020, China
Local Institution - 0039

Shenyang, Liaoning, 110001, China
Local Institution - 0040

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland
Local Institution - 0041

Juiz de Fora, Minas Gerais, 36010-570, Brazil
Local Institution - 0042

Belo Horizonte, Minas Gerais, 30150-221, Brazil
Local Institution - 0043

Ürümqi, Xinjiang, 830001, China
Local Institution - 0044

Changsha, Hunan, 410008, China
Local Institution - 0045

Shanghai, Shanghai Municipality, 200040, China
Local Institution - 0047

Katowice, Silesian Voivodeship, 40-081, Poland
Local Institution - 0049

Shanghai, Shanghai Municipality, 200127, China
Local Institution - 0050

Mexico City, Mexico City, 06700, Mexico
Local Institution - 0051

Guangzhou, Guangdong, 510080, China
Local Institution - 0053

Tianjin, Tianjin Municipality, 300052, China
Local Institution - 0054

New Haven, Connecticut, 06510, United States
Local Institution - 0056

Barranquilla, Atlántico, 080002, Colombia
Local Institution - 0057

Chía, 250001, Colombia
Local Institution - 0060

Pisa, Tuscany, 56126, Italy
Local Institution - 0061

Cologne, 50937, Germany
Local Institution - 0063

Franklin, Wisconsin, 53132, United States
Local Institution - 0064

Allen, Texas, 75013, United States
Local Institution - 0065

Dallas, Texas, 75390, United States
Local Institution - 0066

São José do Rio Preto, São Paulo, 15090000, Brazil
Local Institution - 0067

Tuenmen, 999077, Hong Kong
Local Institution - 0068

Nantes, Loire-Atlantique, 44093 Cedex 1, France
Local Institution - 0069

Brescia, 25123, Italy
Local Institution - 0070

Beijing, Beijing Municipality, 100730, China
Local Institution - 0071

Nanchang, Jiangxi, 330006, China
Local Institution - 0072

Milan, 20132, Italy
Local Institution - 0076

Bucharest, Bucharest, 011172, Romania
Local Institution - 0077

Schaumburg, Illinois, 60195, United States
Local Institution - 0078

Quilmes, Buenos Aires, 1878, Argentina
Local Institution - 0079

Shanghai, Shanghai Municipality, 200025, China
Local Institution - 0080

Guangzhou, Guangdong, 510120, China
Local Institution - 0082

León, Guanajuato, 37000, Mexico
Local Institution - 0083

Puebla City, 72160, Mexico
Local Institution - 0084

Rome, Lazio, 00161, Italy
Local Institution - 0085

New York, New York, 10016, United States
Local Institution - 0086

Bucaramanga, Santander Department, 680003, Colombia
Local Institution - 0087

Miami, Florida, 33136, United States
Local Institution - 0088

Fort Worth, Texas, 76177, United States
Local Institution - 0089

Hohhot, Inner Mongolia, 010050, China
Local Institution - 0090

La Palma, California, 90623, United States
Local Institution - 0092

Shenyang, Liaoning, 110004, China
Local Institution - 0093

Cali, 760035, Colombia
Local Institution - 0094

Râmnicu Vâlcea, Vâlcea County, 247065, Romania
Local Institution - 0095

Milan, Lombardy, 20122, Italy
Local Institution - 0096

Lago Sul, Federal District, 71635580, Brazil
Local Institution - 0097

Padova, Veneto, 35128, Italy
Local Institution - 0098

Rochester, New York, 14642, United States
Local Institution - 0099

Denver, Colorado, 80230, United States
Local Institution - 0100

Bogotá, 110221, Colombia
Local Institution - 0101

Suwon, Kyǒnggi-do, 16499, South Korea
Local Institution - 0102

Gwangju, Kwangju-Kwangyǒkshi, 61469, South Korea
Local Institution - 0103

Lima, 33, Peru
Local Institution - 0104

Lima, 15046, Peru
Local Institution - 0107

Xiamen, Fujian, 361003, China
Local Institution - 0108

Indianapolis, Indiana, 46202, United States
Local Institution - 0109

Tübingen, Baden-Wurttemberg, 72076, Germany
Local Institution - 0110

Bengbu, Anhui, 233017, China
Local Institution - 0111

Planegg, 82152, Germany
Local Institution - 0112

Mexico City, Mexico City, 14080, Mexico
Local Institution - 0114

London, Ontario, N6A 4V2, Canada
Local Institution - 0115

Toronto, Ontario, M5T 2S8, Canada
Local Institution - 0116

Chengdu, Sichuan, 610041, China
Local Institution - 0117

Nanchang, Jiangxi, 330006, China
Local Institution - 0119

Manorhamilton, Leitrim, 0, Ireland
Local Institution - 0120

Erlangen, 91054, Germany
Local Institution - 0122

Lima, 15047, Peru
Local Institution - 0123

San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Local Institution - 0124

Los Angeles, California, 90095, United States
Local Institution - 0125

São Paulo, 05403-000, Brazil
Local Institution - 0126

Calgary, Alberta, T2N 4N1, Canada
Local Institution - 0128

Santa Barbara, California, 93108, United States
Local Institution - 0129

Changzhou, Jiangsu, 213003, China
Local Institution - 0130

Cork, T12 E8YV, Ireland
Local Institution - 0132

Hangzhou, Zhejiang, 310003, China
Local Institution - 0133

Luoyang, Henan, 471003, China
Local Institution - 0135

Wenzhou, Zhejiang, 325000, China
Local Institution - 0136

Rimouski, Quebec, G5L 5T1, Canada
Local Institution - 0137

Wuhan, Hubei, 430022, China
Local Institution - 0138

Córdoba, 5004, Argentina
Local Institution - 0139

Seattle, Washington, 98195, United States
Local Institution - 0140

Buenos Aires, CP1280AEB, Argentina
Local Institution - 0141

Bucharest, Bucharest, 020125, Romania
Local Institution - 0142

Craiova, Dolj, 200347, Romania
Local Institution - 0143

Timișoara, 300766, Romania
Local Institution - 0144

Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea
Local Institution - 0146

Dresden, Saxony, 01307, Germany
Local Institution - 0147

Lawrenceville, Georgia, 30046, United States
Local Institution - 0148

Bucharest, Bucharest, 011053, Romania
Local Institution - 0149

Jinan, Shandong, 250001, China
Local Institution - 0150

Strasbourg, Alsace, 67091, France
Local Institution - 0151

Lübeck, Schleswig-Holstein, 23538, Germany
Local Institution - 0152

Bucharest, Bucharest, 014142, Romania
Local Institution - 0153

Baoding, Hebei, 071030, China
Local Institution - 0154

Naples, 80131, Italy
Local Institution - 0155

Charlotte, North Carolina, 28211, United States
Local Institution - 0156

Tours, 37032, France
Local Institution - 0157

Dublin, D08 E9P6, Ireland
Local Institution - 0158

Taiyuan, 030032, China
Local Institution - 0159

The Bronx, New York, 10467, United States
Local Institution - 0160

Hamilton, Ontario, L8S 4K1, Canada
Local Institution - 0161

Verona, 37134, Italy
Local Institution - 0162

Sofia, 1784, Bulgaria
Local Institution - 0163

Plovdiv, 4000, Bulgaria
Local Institution - 0164

Warsaw, Masovian Voivodeship, 02-118, Poland
Local Institution - 0165

Tampa, Florida, 33614, United States
Local Institution - 0166

Warsaw, Masovian Voivodeship, 02-637, Poland
Local Institution - 0167

Kaunas, Kaunas County, LT-50161, Lithuania
Local Institution - 0168

Istanbul, 34098, Turkey (Türkiye)
Local Institution - 0169

Seoul, 04763, South Korea
Local Institution - 0170

Bogotá, 110231, Colombia
Local Institution - 0172

Dublin, D15 X40D, Ireland
Local Institution - 0173

Le Kremlin-Bicêtre, 94270, France
Local Institution - 0174

Medellín, Antioquia, 050021, Colombia
Local Institution - 0176

Munich, Bavaria, 80336, Germany
Local Institution - 0177

Summit, New Jersey, 07901, United States
Local Institution - 0179

Eagan, Minnesota, 55121, United States
Local Institution - 0180

Manhasset, New York, 11030, United States
Local Institution - 0181

Porto Alegre, Rio Grande do Sul, 90610000, Brazil
Local Institution - 0184

Ankara, 06560, Turkey (Türkiye)
Local Institution - 0185

Campinas, São Paulo, 13015-001, Brazil
Local Institution - 0186

Rio de Janeiro, 20551-030, Brazil
Local Institution - 0187

Ribeirão Preto, São Paulo, 14051-140, Brazil
Local Institution - 0189

Kocaeli, 41380, Turkey (Türkiye)
Local Institution - 0190

Curitiba, Paraná, 80730-150, Brazil
Local Institution - 0191

São Paulo, São Paulo, 04038-002, Brazil
Local Institution - 0193

Tucson, Arizona, 85724, United States
Local Institution - 0195

Chemnitz, 09117, Germany
Local Institution - 0197

San Juan, 00917, Puerto Rico
Local Institution - 0199

Arequipa, 05154, Peru
Local Institution - 0200

Ahmedabad, Gujarat, 380015, India
Local Institution - 0202

Bengaluru, Karnataka, 560010, India
Local Institution - 0203

Caguas, 00725, Puerto Rico
Local Institution - 0204

Atlanta, Georgia, 30318, United States
Local Institution - 0205

Hyderabad, Telangana, 500082, India
Local Institution - 0208

Gurugram, Haryana, 122001, India
Local Institution - 0210

Bucharest, Bucharest, 30463, Romania
Local Institution - 0211

Bełchatów, Łódź Voivodeship, 97-400, Poland
Local Institution - 0212

Poznan, 60-702, Poland
Local Institution - 0213

Vizianagaram, Andhra Pradesh, 0, India
Local Institution - 0215

Bucharest, Bucharest, 041303, Romania
Local Institution - 0216

Iași, Iaşi, 700127, Romania
Local Institution - 0217

Sofia, 1407, Bulgaria
Local Institution - 0219

Lubbock, Texas, 79415, United States
Local Institution - 0220

Nanchang, Jiangxi, 330006, China
Local Institution - 0222

Hyderabad, Telangana, 500038, India
Local Institution - 0224

Salvador, Estado de Bahia, 40150-150, Brazil
Local Institution - 0225

New Orleans, Louisiana, 70121, United States
Local Institution - 0227

Morton Grove, Illinois, 60053, United States
Local Institution - 0228

Lawrenceville, Georgia, 30044, United States
Local Institution - 0229

Phoenix, Arizona, 85006, United States
Local Institution - 0236

Chisinau, 2025, Moldova
Local Institution - 0238

Chisinau, Chișinău, MD-2051, Moldova
Local Institution - 0240

Buenos Aires, C1023AAB, Argentina
Local Institution - 0242

Plantation, Florida, 33317, United States
Local Institution - 0243

Surat, Gujarat, 395010, India
Local Institution - 0245

Charlotte, North Carolina, 28207, United States
Local Institution - 0246

Summerville, South Carolina, 29486, United States
Local Institution - 0247

La Mesa, California, 91942, United States
Local Institution - 0248

Sacramento, California, 95817, United States
Local Institution - 0249

Coral Springs, Florida, 33065, United States
Local Institution - 0250

Houston, Texas, 77090, United States
Local Institution - 0252

San Juan, 00909, Puerto Rico
Local Institution - 0253

San Diego, California, 92128, United States
Velocity Clinical Research, Lublin

Lublin, 20-362, Poland

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