A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

NCT05946941 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: IM011-10692023-503327-26U111-1289-6072
• Study Type: interventional
• Target: 774
• Locations: 32 countries
• Sites: 197

Brief Summary

The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.

Conditions

Sjögren's Syndrome

Keywords

Deucravacitinib; Sjogren's Syndrome; BMS-986165; POETYK; Sjogren Syndrome; Sjogren-Larson Syndrome; Gougerot-Sjogren; Gougerot Sjogren Syndrome; Sjogren; Sjogren's; Sjogren Disease; Sjogren's Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52

  Baseline, Week 52

Secondary Outcomes (19)

• Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52

  Baseline, Week 52

• Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52

  Baseline, Week 52

• Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52

  Baseline, Week 52

• Number of participants with ESSDAI < 5 at Week 52

  Baseline, Week 52

• Change from baseline in ESSDAI at Week 24

  Baseline, Week 24

Study Arms (3)

Deucravacitinib, Dose 1

EXPERIMENTAL

Drug: Deucravacitinib

Deucravacitinib, Dose 2

EXPERIMENTAL

Drug: Deucravacitinib

Placebo, followed by Deucravacitinib Dose 1 or Dose 2

PLACEBO COMPARATOR

Drug: Deucravacitinib; Other: Placebo

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Also known as: BMS-986165

Deucravacitinib, Dose 1; Deucravacitinib, Dose 2; Placebo, followed by Deucravacitinib Dose 1 or Dose 2

Placebo OTHER

Specified dose on specified days

Placebo, followed by Deucravacitinib Dose 1 or Dose 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS at screening (score ≥ 4), and who have disease duration (from time of initial clinical SjS diagnosis) of at least 16 weeks prior to screening.
• Have moderate to severe SjS ESSDAI ≥ 5.
• Short duration of disease (≤ 10 years) before screening.
• A stimulated whole salivary flow (SWSF) ≥ 0.05 mililiters/minute (mL/minute).
• Positive anti-Sjögren's syndrome-associated antigen A (anti-Ro/SSA) at screening.

You may not qualify if:

• Autoimmune disease other than SjS (for example, rheumatoid arthritis, systemic lupus erthrematosus \[SLE\], systemic sclerosis).
• Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment or requiring adjustment in medication within the 3 months before screening to control symptoms; participants with fibromyalgia that is well controlled on stable treatment may otherwise be considered.
• Medical condition associated with sicca syndrome.
• Previous exposure to tyrosine kinase 2 (TYK2) inhibitors such as deucravacitinib or related compounds.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (199)

Local Institution - 0228

Fullerton, California, 92835, United States

Location

Local Institution - 0222

La Palma, California, 90623, United States

Location

Local Institution - 0218

San Francisco, California, 94143, United States

Location

Local Institution - 0203

Santa Monica, California, 90404, United States

Location

Local Institution - 0067

Denver, Colorado, 80230, United States

Location

Local Institution - 0049

Clearwater, Florida, 33765, United States

Location

Local Institution - 0226

Cooper City, Florida, 33024, United States

Location

Local Institution - 0223

Sarasota, Florida, 34239, United States

Location

Local Institution - 0140

Augusta, Georgia, 30912, United States

Location

Local Institution - 0229

Lawrenceville, Georgia, 30046, United States

Location

Local Institution - 0174

Skokie, Illinois, 60076, United States

Location

Local Institution - 0016

Kansas City, Kansas, 66160, United States

Location

Local Institution - 0017

Baton Rouge, Louisiana, 70836, United States

Location

Local Institution - 0125

Monroe, Louisiana, 71203, United States

Location

Local Institution - 0187

Baltimore, Maryland, 21224-2746, United States

Location

Local Institution - 0173

Boston, Massachusetts, 02111, United States

Location

Local Institution - 0131

Eagan, Minnesota, 55123, United States

Location

Local Institution - 0138

Summit, New Jersey, 07901, United States

Location

Local Institution - 0009

Albuquerque, New Mexico, 87106, United States

Location

Local Institution - 0184

Mineola, New York, 11501, United States

Location

Local Institution - 0224

Salisbury, North Carolina, 28144, United States

Location

Local Institution - 0130

Duncansville, Pennsylvania, 16635, United States

Location

Local Institution - 0022

Jackson, Tennessee, 38305, United States

Location

Local Institution - 0144

Allen, Texas, 75013, United States

Location

Local Institution - 0227

Katy, Texas, 77494, United States

Location

Local Institution - 0175

Plano, Texas, 75024, United States

Location

Local Institution - 0133

Seattle, Washington, 98195, United States

Location

Local Institution - 0189

Spokane, Washington, 99204, United States

Location

Local Institution - 0050

San Isidro, Alabama, 1643, Argentina

Location

Local Institution - 0100

CABA, Buenos Aires, 1114, Argentina

Location

Local Institution - 0003

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1123AAO, Argentina

Location

Local Institution - 0019

Quilmes, Buenos Aires, 1878, Argentina

Location

Local Institution - 0026

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Local Institution - 0137

CABA, 1405, Argentina

Location

Local Institution - 0109

City of Buenos Aires, 1425, Argentina

Location

Local Institution - 0061

Córdoba, X5004AUL, Argentina

Location

Local Institution - 0120

Woodville South, South Australia, 5011, Australia

Location

Local Institution - 0117

Graz, A-8036, Austria

Location

Local Institution - 0087

Vienna, A-1180, Austria

Location

Local Institution - 0172

Ghent, 9000, Belgium

Location

Local Institution - 0170

Vitória, Espírito Santo, 29041-295, Brazil

Location

Local Institution - 0106

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Local Institution - 0091

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

Local Institution - 0055

Porto Alegre, Rio Grande do Sul, 90560-030, Brazil

Location

Local Institution - 0018

São Paulo, São Paulo, 04266-010, Brazil

Location

Local Institution - 0111

Uberlândia, 38405-320, Brazil

Location

Local Institution - 0008

Plovdiv, 4001, Bulgaria

Location

Local Institution - 0221

Sofia, 1618, Bulgaria

Location

Local Institution - 0134

Vancouver, British Columbia, V5Z 1L7, Canada

Location

Local Institution - 0063

Toronto, Ontario, M5T 2S8, Canada

Location

Local Institution - 0004

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Local Institution - 0056

Trois-Rivières, Quebec, G8Z1Y2, Canada

Location

Local Institution - 0136

Santiago, Providencia, 7501126, Chile

Location

Local Institution - 0032

Viña del Mar, Región de Valparaíso, 2531172, Chile

Location

Local Institution - 0097

Santiago, Santiago Metropolitan, 7500710, Chile

Location

Local Institution - 0015

Santiago de Chlie, Santiago Metropolitan, 8207257, Chile

Location

Local Institution - 0216

Santiago, 8350488, Chile

Location

Local Institution - 0200

Valdivia, 5110683, Chile

Location

Local Institution - 0153

Beijing, Beijing Municipality, 100034, China

Location

Local Institution - 0156

Beijing, Beijing Municipality, 100044, China

Location

Local Institution - 0160

Beijing, Beijing Municipality, 100191, China

Location

Local Institution - 0155

Xiamen, Fujian, 361003, China

Location

Local Institution - 0095

Guangzhou, Guangdong, 510080, China

Location

Local Institution - 0212

Shenzhen, Guangdong, 518020, China

Location

Local Institution - 0214

Zhengzhou, Henan, 450052, China

Location

Local Institution - 0149

Wuhan, Hubei, 430030, China

Location

Local Institution - 0094

Changsha, Hunan, 410011, China

Location

Local Institution - 0158

Changsha, Hunan, 410024, China

Location

Local Institution - 0150

Hohhot, Inner Mongolia, 10000, China

Location

Local Institution - 0215

Nanjing, Jiangsu, 210008, China

Location

Local Institution - 0159

Nanjing, Jiangsu, 210029, China

Location

Local Institution - 0154

Suzhou, Jiangsu, 215006, China

Location

Local Institution - 0177

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0213

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0162

Pingxiang, Jiangxi, 337099, China

Location

Local Institution - 0101

Xi'an, Shaanxi, 710061, China

Location

Local Institution - 0182

Taiyuan, Shan1xi, 030032, China

Location

Local Institution - 0102

Shanghai, Shanghai Municipality, 200000, China

Location

Local Institution - 0151

Shanghai, Shanghai Municipality, 200065, China

Location

Local Institution - 0157

Shanghai Shi, Shanghai Sheng, 200011, China

Location

Local Institution - 0178

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0179

Ürümqi, Xinjiang Sheng, 830001, China

Location

Local Institution - 0181

Hangzhou, Zhejiang, 310003, China

Location

Local Institution - 0152

Hangzhou, Zhejiang, 314408, China

Location

Local Institution - 0161

Ningbo, Zhejiang, 315010, China

Location

Local Institution - 0093

Wenzhou, Zhejiang, 325000, China

Location

Local Institution - 0168

Barranquilla, Atlántico, 080003, Colombia

Location

Local Institution - 0043

Chía, Cundinamarca, 250001, Colombia

Location

Local Institution - 0037

Bogota D.C, 110221, Colombia

Location

Local Institution - 0199

Helsinki, 00290, Finland

Location

Local Institution - 0135

Kuopio, 70100, Finland

Location

Local Institution - 0119

Turku, 20520, Finland

Location

Local Institution - 0005

Amiens, 80054, France

Location

Local Institution - 0073

Bordeaux, 33075, France

Location

Local Institution - 0070

Grenoble, 38043, France

Location

Local Institution - 0074

Le Havre, 76083, France

Location

Local Institution - 0167

Le Kremlin-Bictre, 94270, France

Location

Local Institution - 0025

Paris, 75012, France

Location

Local Institution - 0107

Paris, 75014, France

Location

Local Institution - 0057

Paris, 75651, France

Location

Local Institution - 0079

Munich, Bavaria, 80336, Germany

Location

Local Institution - 0092

Berlin, 10117, Germany

Location

Local Institution - 0031

Freiburg im Breisgau, 79106, Germany

Location

Local Institution - 0033

Hamburg, 20095, Germany

Location

Local Institution - 0075

Tübingen, 72076, Germany

Location

Local Institution - 0051

Würzburg, 97080, Germany

Location

Local Institution - 0077

Athens, 11527, Greece

Location

Local Institution - 0108

Larissa, 41110, Greece

Location

Local Institution - 0083

Debrecen, 4032, Hungary

Location

Local Institution - 0090

Gyula, 5700, Hungary

Location

Local Institution - 0145

Ramat Gan, IA, 5265601, Israel

Location

Local Institution - 0142

Kfar Saba, 4428164, Israel

Location

Local Institution - 0065

Brescia, 25123, Italy

Location

Local Institution - 0029

Milan, 20122, Italy

Location

Local Institution - 0124

Naples, 80131, Italy

Location

Local Institution - 0128

Pisa, 56126, Italy

Location

Local Institution - 0069

Rome, 00128, Italy

Location

Local Institution - 0081

Udine, 33100, Italy

Location

Local Institution - 0146

Nagoya, Aichi-ken, 457-8511, Japan

Location

Local Institution - 0205

Toyoake-shi, Aichi-ken, 470-1192, Japan

Location

Local Institution - 0148

Kitakyushu-shi, Fukuoka, 807-8556, Japan

Location

Local Institution - 0122

Sapporo, Hokkaido, 0608543, Japan

Location

Local Institution - 0188

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution - 0211

Nishinomiya-shi, Hyōgo, 6638501, Japan

Location

Local Institution - 0193

Tsukuba, Ibaraki, 3058576, Japan

Location

Local Institution - 0202

Kahoku-gun, Ishikawa-ken, 9200293, Japan

Location

Local Institution - 0118

Kanazawa, Ishikawa-ken, 9208641, Japan

Location

Local Institution - 0206

Kawasaki-shi, Kanagawa, 2168511, Japan

Location

Local Institution - 0191

Yokohama, Kanagawa, 2458575, Japan

Location

Local Institution - 0139

Sendai, Miyagi, 980-8574, Japan

Location

Local Institution - 0147

Nagasaki, Nagasaki, 8528501, Japan

Location

Local Institution - 0129

Sasebo, Nagasaki, 8571195, Japan

Location

Local Institution - 0207

Kurashiki, Okayama-ken, 7100824, Japan

Location

Local Institution - 0198

Ōtsu, Shiga, 5250072, Japan

Location

Local Institution - 0194

Hamamatsu, Shizuoka, 4313192, Japan

Location

Local Institution - 0195

Shimotsugagun, Tochigi, 3210293, Japan

Location

Local Institution - 0210

Bunkyo-ku, Tokyo, 1138421, Japan

Location

Local Institution - 0196

Bunkyo-ku, Tokyo, 1138519, Japan

Location

Local Institution - 0190

Chuo-ku, Tokyo, 1048560, Japan

Location

Local Institution - 0201

Meguro-ku, Tokyo, 1528902, Japan

Location

Local Institution - 0208

Meguro-ku, Tokyo, 1538515, Japan

Location

Local Institution - 0204

Shinagawa-ku, Tokyo, 1420054, Japan

Location

Local Institution - 0197

Shinjuku, Tokyo, 1608582, Japan

Location

Local Institution - 0192

tabashi City, Tokyo, 1738610, Japan

Location

Local Institution - 0020

León, Guanajuato, 37000, Mexico

Location

Local Institution - 0023

Guadalajara, Jalisco, 44620, Mexico

Location

Local Institution - 0048

Guadalajara, Jalisco, 44690, Mexico

Location

Local Institution - 0169

Mexico City, Mexico City, 11850, Mexico

Location

Local Institution - 0001

Groningen, 9713 GZ, Netherlands

Location

Local Institution - 0105

Rotterdam, 3015 GD, Netherlands

Location

Local Institution - 0047

Jesus Maria, Lima region, 15076, Peru

Location

Local Institution - 0011

Santiago de Surco, Lima region, 1111, Peru

Location

Local Institution - 0171

Lima, Lima 26, Peru

Location

Local Institution - 0084

Krakow, Lesser Poland Voivodeship, 30-363, Poland

Location

Local Institution - 0054

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

Local Institution - 0141

Warsaw, Woj. Mazowieckie, 02-118, Poland

Location

Local Institution - 0024

Bydgoszcz, 85-065, Poland

Location

Local Institution - 0085

Bydgoszcz, 85-168, Poland

Location

Local Institution - 0040

Lublin, 20-412, Poland

Location

Local Institution - 0089

Poznan, 60-693, Poland

Location

Local Institution - 0080

Warsaw, 02 665, Poland

Location

Local Institution - 0076

Warsaw, 02-637, Poland

Location

Local Institution - 0185

Warsaw, 03-291, Poland

Location

Local Institution - 0064

Wroclaw, 53-224, Poland

Location

Local Institution - 0036

Wroclaw, 54-049, Poland

Location

Local Institution - 0028

Lisbon, 1050-078, Portugal

Location

Local Institution - 0014

Lisbon, 1649-035, Portugal

Location

Local Institution - 0143

San Juan, 00917, Puerto Rico

Location

Local Institution - 0127

San Juan, 00918, Puerto Rico

Location

Local Institution - 0220

Cluj-Napoca, Cluj, 400006, Romania

Location

Local Institution - 0041

Brasov, 500283, Romania

Location

Local Institution - 0219

Bucharest, 011658, Romania

Location

Local Institution - 0110

Seongdong-gu, Seoul, 04763, South Korea

Location

Local Institution - 0042

Gwangju, 61469, South Korea

Location

Local Institution - 0126

Seoul, 06591, South Korea

Location

Local Institution - 0209

Seoul, 5030, South Korea

Location

Local Institution - 0038

Mérida, Badajoz, 06800, Spain

Location

Local Institution - 0059

Santander, Cantabria, 39008, Spain

Location

Local Institution - 0114

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Local Institution - 0112

A Coruña, 15006, Spain

Location

Local Institution - 0068

Santiago de Compostela, 15702, Spain

Location

Local Institution - 0071

Seville, 41010, Spain

Location

Local Institution - 0166

Gothenburg, 405 30, Sweden

Location

Local Institution - 0164

Stockholm, 11361, Sweden

Location

Local Institution - 0013

Bern, 3010, Switzerland

Location

Local Institution - 0034

Sankt Gallen, 9007, Switzerland

Location

Local Institution - 0116

Kaohsiung City, 83301, Taiwan

Location

Local Institution - 0012

Taichung, 40447, Taiwan

Location

Local Institution - 0002

Taichung, 40705, Taiwan

Location

Local Institution - 0027

Taipei, 100, Taiwan

Location

Local Institution - 0045

Taoyuan, 333, Taiwan

Location

Local Institution - 0035

Yenimahalle, Ankara, 06500, Turkey (Türkiye)

Location

Local Institution - 0088

Ankara, 06100, Turkey (Türkiye)

Location

Local Institution - 0007

Antalya, 7058, Turkey (Türkiye)

Location

Local Institution - 0044

Istanbul, 34098, Turkey (Türkiye)

Location

Local Institution - 0176

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Local Institution - 0217

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Local Institution - 0030

Birmingham, B15 2WB, United Kingdom

Location

Local Institution - 0060

Cannock, WS11 5XY, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: September 11, 2023
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): November 16, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (28); KR (4); AR (8); TU (4); CH (2); BR (6); CN (28); CO (3); JP (26); TW (5); CA (4); FR (8); IL (2); AU (1); BU (2); FI (3); NL (2); RO (3); PE (3); CL (6); DE (6); IT (6); PL (12); PT (2); BE (1); HU (2); GR (2); PR (2); SE (2); GB (4); ES (6); ME (4)