Sjögren's Syndrome Clinical Trial
— POETYK SjS-1Official title:
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)
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.
| Status | Recruiting |
| Enrollment | 756 |
| Est. completion date | November 16, 2028 |
| Est. primary completion date | November 18, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria - Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS with disease duration (from time of 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. Exclusion Criteria - 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. - Other protocol-defined Inclusion/Exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0058 | Buenos Aires | |
| Argentina | Local Institution - 0137 | Buenos Aires | |
| Argentina | Iro Research | Caba | Buenos Aires |
| Argentina | Local Institution - 0003 | Caba | Buenos Aires |
| Argentina | Local Institution - 0109 | City of Buenos Aires | |
| Argentina | Local Institution - 0039 | Cordoba | |
| Argentina | Local Institution - 0061 | Cordoba | General Paz |
| Argentina | Local Institution - 0019 | Quilmes | Buenos Aires |
| Argentina | Local Institution - 0050 | San Isidro | Alabama |
| Argentina | Local Institution - 0026 | San Miguel de Tucuman | Tucuman |
| Australia | Local Institution - 0165 | Nedlands | Western Australia |
| Australia | The Queen Elizabeth Hospital | Woodville South | South Australia |
| Austria | Medical University of Graz | Graz | |
| Austria | Evangelisches Krankenhaus Wien | Wien | |
| Belgium | Local Institution - 0183 | Aalst | |
| Belgium | Local Institution - 0172 | Gent | |
| Brazil | Local Institution - 0106 | Belo Horizonte | Minas Gerais |
| Brazil | Local Institution - 0091 | Juiz de Fora | MG |
| Brazil | Local Institution - 0055 | Porto Alegre | RS |
| Brazil | CEPIC Centro Paulista de Investigacao Clinica | Sao Paulo | |
| Brazil | Local Institution - 0111 | Uberlandia | |
| Brazil | Hospital Universitario Cassiano Antonio Moraes | Vitoria | ES |
| Bulgaria | Local Institution - 0008 | Plovdiv | |
| Bulgaria | Local Institution - 0221 | Sofia | |
| Canada | Diex Recherche Sherbrooke | Sherbrooke | Quebec |
| Canada | Local Institution - 0063 | Toronto | Ontario |
| Canada | Centre De Recherche Musculo-Squelettique | Trois Rivières | Quebec |
| Canada | Local Institution - 0134 | Vancouver | British Columbia |
| Chile | Local Institution - 0099 | Osorno | |
| Chile | Local Institution - 0015 | Puente Alto | Region Metropolitana |
| Chile | Estudios Clinicos GyC | Santiago | |
| Chile | Local Institution - 0097 | Santiago | RM |
| Chile | Local Institution - 0121 | Santiago | |
| Chile | Local Institution - 0136 | Santiago | Metropolitana |
| Chile | Clinical Research Chile SpA | Valdivia | Los Rios |
| Chile | Local Institution - 0103 | Valdivia | Los Rios |
| Chile | Local Institution - 0032 | Vina del Mar | |
| China | Local Institution - 0098 | Baotou Shi | Inner Mongolia |
| China | Peking University People's Hospital - Institute of Rheumatology and Immunology | Beijing | Beijing |
| China | Peking University Third Hospital | Beijing | Beijing |
| China | Peking University First Hospital (Beida Hospital) (No.1 Hospital Affiliated to Beijing Medical University) | Beijing Shi | Beijing |
| China | Hunan Province People's Hospital | Changsha | Hunan |
| China | The Second Xiangya Hospital of Central South University | Changsha | Hunan |
| China | West China Hospital Sichuan University | Chengdu | Sichuan |
| China | Local Institution - 0096 | Chongqing | Chongqing |
| China | Guangdong Provincial People's Hospital | Guangzhou | Guangdong |
| China | The First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
| China | Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang |
| China | Inner Mongolia Medical University IMMU - The Affiliated Hospital | Hohhot | Inner Mongolia |
| China | Local Institution - 0163 | Jiujiang | Jiangxi |
| China | Local Institution - 0180 | Luoyang | Henan |
| China | 1st Hospital of Nanchang University | Nanchang | Jiangxi |
| China | Jiangxi Provincial Peoples Hospital | Nanchang | Jiangxi |
| China | Local Institution - 0215 | Nanjing | Jiangsu |
| China | Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital) | Nanjing | Jiangsu |
| China | Ningbo First Hospital | Ningbo | Jiangsu |
| China | Pingxiang Peoples Hospital | Pingxiang | Jiangxi |
| China | Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine -Shanghai Institute of Rheumatology | Shanghai | Shanghai |
| China | Tongji University - Tongji Hospital | Shanghai | Shanghai |
| China | Local Institution - 0157 | Shanghai Shi | Shanghai Sheng |
| China | Shenzhen Peoples Hospital | Shenzhen | Guangdong |
| China | 1st affiliated Hospital of Suzhou University | Suzhou | Jiangsu |
| China | Shanxi Bethune Hospital,Shanxi Academy of Medical Sciences | Taiyuan | Shanxi |
| China | Xinjiang Uygur Autonomous Region People's Hospital | Urumqi | Xinjiang Sheng |
| China | Wenzhou Medical University (WMU) - The First Affiliated Hospital | Wenzhou | Zhejiang |
| China | Tongji Hospital affiliated to Huazhong University of Science and Technology | Wuhan | Hubei |
| China | Local Institution - 0155 | Xiamen | Fujian |
| China | The First Affiliated Hospital of Xian Jiaotong University | Xian | Shaanxi |
| China | 1st Hospital of Zhengzhou University | Zhengzhou | Henan |
| Colombia | Local Institution - 0168 | Barranquilla | Atlantico |
| Colombia | Local Institution - 0037 | Bogota | Cundinamarca |
| Colombia | Local Institution - 0043 | Chia | Cundinamarca |
| Denmark | Local Institution - 0186 | Aarhus | Region Midt |
| Denmark | Local Institution - 0006 | Glostrup | |
| Finland | Local Institution - 0199 | Helsinki | |
| Finland | Local Institution - 0135 | Kuopio | |
| Finland | Local Institution - 0119 | Turku | |
| France | Local Institution - 0005 | Amiens | |
| France | CHU de Bordeaux - Hopital Saint-Andre | Bordeaux | |
| France | Local Institution - 0070 | Grenoble | |
| France | Local Institution - 0074 | Le Havre Cedex | |
| France | Local Institution - 0167 | Le Kremlin-Bictre | |
| France | Local Institution - 0078 | Marseille | |
| France | Local Institution - 0072 | Orleans | Centre |
| France | Local Institution - 0025 | Paris | |
| France | Local Institution - 0057 | Paris | |
| France | Local Institution - 0107 | Paris | |
| Germany | Local Institution - 0092 | Berlin | |
| Germany | Local Institution - 0031 | Freiburg | |
| Germany | Hamburger Rheuma Forschungszentrum 2 | Hamburg | |
| Germany | Local Institution - 0079 | Munich | Bayern |
| Germany | Universitaetsklinikum Tuebingen | Tuebingen | |
| Germany | Local Institution - 0051 | Wurzburg | Bayern |
| Greece | Local Institution - 0077 | Athens | |
| Greece | Local Institution - 0052 | Athina | |
| Greece | Local Institution - 0108 | Larissa | |
| Hungary | Local Institution - 0113 | Budapest | |
| Hungary | Local Institution - 0115 | Budapest, IX | Válassz Egy Opciót… |
| Hungary | Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center) | Debrecen | |
| Hungary | Local Institution - 0090 | Gyula | |
| Israel | Local Institution - 0142 | Kfar Sava | |
| Israel | Local Institution - 0145 | Ramat Gan | IA |
| Italy | Local Institution - 0065 | Brescia | |
| Italy | Local Institution - 0029 | Milano | |
| Italy | Local Institution - 0124 | Napoli | |
| Italy | Local Institution - 0082 | Padua | |
| Italy | Local Institution - 0128 | Pisa | |
| Italy | Local Institution - 0062 | Rome | |
| Italy | Local Institution - 0069 | Rome | |
| Italy | Local Institution - 0081 | Udine | |
| Japan | Juntendo University Hospital | Bunkyo-ku | Tokyo |
| Japan | Tokyo Medical and Dental University Hospital | Bunkyo-ku | Tokyo |
| Japan | St. Luke's International Hospital | Chuo-ku | Tokyo |
| Japan | Local Institution - 0194 | Higashi-ku | Shizuoka |
| Japan | Nihon University Itabashi Hospital | Itabashi City | Tokyo |
| Japan | Kanazawa Medical University Hospital | Kahoku-gun | Ishikawa |
| Japan | Kanazawa University Hospital | Kanazawa-shi | Ishikawa |
| Japan | Local Institution - 0206 | Kawasaki-shi | Kanagawa |
| Japan | Local Institution - 0148 | Kitakyushu-shi | Fukuoka |
| Japan | Kurashiki Medical Clinic | Kurashiki | Okayama |
| Japan | Local Institution - 0208 | Meguro-ku | Tokyo |
| Japan | National Hospital Organization Tokyo Medical Center | Meguro-ku | Tokyo |
| Japan | Local Institution - 0147 | Nagasaki-Shi | Nagasaki |
| Japan | Kojunkai Daido Clinic | Nagoya-shi | Aichi |
| Japan | Hyogo Medical University Hospital | Nishinomiya-shi | Hyogo |
| Japan | Local Institution - 0198 | Otsu | Shiga |
| Japan | Local Institution - 0122 | Sapporo | Hokkaido |
| Japan | Hokkaido University Hospital | Sapporo-shi | Hokkaido |
| Japan | Local Institution - 0129 | Sasebo | Nagasaki |
| Japan | Tohoku University Hospital | Sendai-shi | Miyagi |
| Japan | Local Institution - 0195 | Shimotsugagun | Tochigi |
| Japan | Local Institution - 0204 | Shinagawa-ku | Tokyo |
| Japan | Local Institution - 0197 | Shinjuku | Tokyo |
| Japan | Local Institution - 0205 | Toyoake-shi | Aichi |
| Japan | Tsukuba University Hospital | Tsukuba City | Ibaraki |
| Japan | National Hospital Organization Yokohama Medical Center | Yokohama | Kanagawa |
| Korea, Republic of | Chonnam National University Hospital | Gwangju | |
| Korea, Republic of | Konkuk University Medical Center | Seoul | |
| Korea, Republic of | Local Institution - 0110 | Seoul | |
| Korea, Republic of | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | |
| Mexico | Local Institution - 0021 | Chihuahua | |
| Mexico | Local Institution - 0023 | Guadalajara | Jalisco |
| Mexico | Local Institution - 0048 | Guadalajara | Jalisco |
| Mexico | Local Institution - 0020 | Leon | Guanajuato |
| Mexico | Local Institution - 0169 | Mexico | |
| Netherlands | Local Institution - 0001 | Groningen | |
| Netherlands | Local Institution - 0046 | Leeuwarden | Friesland |
| Netherlands | Local Institution - 0105 | Rotterdam | Zuid-Holland |
| Peru | Local Institution - 0047 | Jesus Maria | Lima |
| Peru | Local Institution - 0171 | Lima | |
| Peru | Local Institution - 0011 | Santiago de Surco | Lima |
| Poland | Local Institution - 0024 | Bydgoszcz | |
| Poland | Szpital Uniwersytecki nr 2 im.dr. Jana Biziela w Bydgoszczy | Bydgoszcz | |
| Poland | Centrum Medyczne PLEJADY | Krakow | Malopolskie |
| Poland | Local Institution - 0040 | Lublin | Lubelskie |
| Poland | Med-Polonia Sp. zo.o. | Poznan | |
| Poland | FutureMeds Targowek | Warsaw | |
| Poland | Local Institution - 0054 | Warsaw | Mazowieckie |
| Poland | Reuma Park Warszawa | Warsawa | |
| Poland | Local Institution - 0010 | Warszawa | Woj. Mazowieckie |
| Poland | Local Institution - 0076 | Warszawa | |
| Poland | Rheuma Medicus | Warszawa | Woj. Mazowieckie |
| Poland | Local Institution - 0036 | Wroclaw | |
| Poland | Local Institution - 0064 | Wroclaw | Woj. Dolnoslaskie |
| Portugal | Local Institution - 0028 | Lisboa | |
| Portugal | Centro Hospitalar Universitario Lisboa Norte E.P.E. (CHULN) - Hospital de Santa Maria | Lisbon | |
| Puerto Rico | GCM Medical Group | San Juan | |
| Puerto Rico | Mindful Medical Research | San Juan | |
| Romania | CMDTA Neomed SRL | Brasov | |
| Romania | Local Institution - 0219 | Bucharest | |
| Romania | Local Institution - 0220 | Cluj-Napoca | |
| Romania | Local Institution - 0104 | Iasi | |
| Spain | Hospital Universitario de A Coruña (CHUAC) | A Coruna | |
| Spain | Local Institution - 0114 | La Laguna | Santa Cruz De Tenerife |
| Spain | Local Institution - 0038 | Merida | |
| Spain | Local Institution - 0059 | Santander | Cantabria |
| Spain | Clinica GAIAS Santiago | Santiago De Compostela | |
| Spain | Hospital Infantaluisa | Sevilla | |
| Sweden | Local Institution - 0166 | Gotenburg | |
| Sweden | Local Institution - 0164 | Solna | |
| Switzerland | Local Institution - 0066 | Basel | Baden-Württemberg |
| Switzerland | Local Institution - 0013 | Bern | |
| Switzerland | Local Institution - 0034 | Southwest | |
| Taiwan | Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | |
| Taiwan | China Medical University Hospital CMUH | Taichung | |
| Taiwan | Local Institution - 0002 | Taichung | |
| Taiwan | Local Institution - 0027 | Taipei City | |
| Taiwan | Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital | Taoyuan City | |
| Turkey | Local Institution - 0035 | Ankara | |
| Turkey | Local Institution - 0088 | Ankara | |
| Turkey | Local Institution - 0007 | Antalya | |
| Turkey | Local Institution - 0044 | Istanbul | |
| Turkey | Local Institution - 0086 | Istanbul | |
| United Kingdom | Local Institution - 0030 | Birmingham | |
| United Kingdom | Local Institution - 0060 | Cannock | |
| United Kingdom | Local Institution - 0053 | Newcastle Upon Tyne | Tyne And Wear |
| United Kingdom | Local Institution - 0176 | Southampton | Hampshire |
| United Kingdom | Local Institution - 0217 | Wolverhampton | West Midlands |
| United States | New Mexico Clinical Research Osteoporosis | Albuquerque | New Mexico |
| United States | Arthritis and Rheumatology Research Institute | Allen | Texas |
| United States | Local Institution - 0140 | Augusta | Georgia |
| United States | Johns Hopkins Medicine - Jerome L. Greene Sjogrens Syndrome Center | Baltimore | Maryland |
| United States | Ochsner Health Center - Baton Rouge | Baton Rouge | Louisiana |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | Clinical Research of West Florida, Inc | Clearwater | Florida |
| United States | Local Institution - 0132 | Corvallis | Oregon |
| United States | Denver Arthritis Clinic | Denver | Colorado |
| United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
| United States | Saint Paul Rheumatology | Eagan | Minnesota |
| United States | Local Institution - 0123 | Hopkinsville | Kentucky |
| United States | West Tennessee Research Institute | Jackson | Tennessee |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | NYU Langone Hospital - Long Island | Mineola | New York |
| United States | Arthritis and Diabetes Clinic | Monroe | Louisiana |
| United States | Trinity Universal Research Associates | Plano | Texas |
| United States | Local Institution - 0218 | San Francisco | California |
| United States | Providence St. John's Health Center | Santa Monica | California |
| United States | University of Washington Medical Center | Seattle | Washington |
| United States | Clinic of Robert Hozman/Clinical Investigation Specialists Inc. | Skokie | Illinois |
| United States | Arthritis Northwest | Spokane | Washington |
| United States | Institute for Rheumatic & Autoimmune Diseases, Overlook Medical Center | Summit | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, Romania, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 | Baseline, Week 52 | ||
| Secondary | Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52 | Baseline, Week 52 | ||
| Secondary | Number of participants with decrease in ESSPRI = 1 or 15% from baseline at Week 52 | Baseline, Week 52 | ||
| Secondary | Number of participants with decrease in ESSDAI = 3 points from baseline at Week 52 | Baseline, Week 52 | ||
| Secondary | Number of participants with ESSDAI < 5 at Week 52 | Baseline, Week 52 | ||
| Secondary | Change from baseline in ESSDAI at Week 24 | Baseline, Week 24 | ||
| Secondary | Change from baseline in stimulated whole salivary flow (SWSF) at Week 52 | Baseline, Week 52 | ||
| Secondary | Change from baseline in physician global assessment (PhGA) at Week 52 | Baseline, Week 52 | ||
| Secondary | Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52 | Baseline, Week 52 | ||
| Secondary | Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52 | Baseline, Week 52 | ||
| Secondary | Change from baseline in oral dryness NRS at Week 52 | Baseline, Week 52 | ||
| Secondary | Change from baseline in joint/ muscle pain NRS at Week 52 | Baseline, Week 52 | ||
| Secondary | Number of participants with adverse events (AEs) | Up to Week 160 | ||
| Secondary | Number of participants with serious AEs (SAEs) | Up to Week 160 | ||
| Secondary | Number of participants with AEs leading to discontinuation of treatment and study discontinuation | Up to Week 160 | ||
| Secondary | Number of participants with AEs of special interest (AESIs) | Up to Week 160 | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to Week 160 | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to Week 156 | ||
| Secondary | Number of participants with vital sign abnormalities | Up to Week 160 |
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