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Active (not recruiting) Phase 3 NCT05946941

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

Phase 3 – large-scale trial before approval
Conditions: Sjögren's Syndrome

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria * 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. 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.
Locations 30
Argentina (1)
Local Institution - 0050
San Isidro , Alabama
Australia (1)
Local Institution - 0120
Woodville South , South Australia
Belgium (1)
Local Institution - 0172
Ghent
Brazil (1)
Local Institution - 0170
Vitória , Espírito Santo
Bulgaria (1)
Local Institution - 0008
Plovdiv
Canada (1)
Local Institution - 0134
Vancouver , British Columbia
Chile (1)
Local Institution - 0136
Santiago , Providencia
China (1)
Local Institution - 0153
Beijing , Beijing Municipality
Colombia (1)
Local Institution - 0168
Barranquilla , Atlántico
Finland (1)
Local Institution - 0199
Helsinki
France (1)
Local Institution - 0005
Amiens
Germany (1)
Local Institution - 0079
Munich , Bavaria
Greece (1)
Local Institution - 0077
Athens
Hungary (1)
Local Institution - 0083
Debrecen
Israel (1)
Local Institution - 0145
Ramat Gan , IA
Italy (1)
Local Institution - 0065
Brescia
Japan (1)
Local Institution - 0146
Nagoya , Aichi-ken
Mexico (1)
Local Institution - 0020
León , Guanajuato
Netherlands (1)
Local Institution - 0001
Groningen
Peru (1)
Local Institution - 0047
Jesus Maria , Lima region
Poland (1)
Local Institution - 0084
Krakow , Lesser Poland Voivodeship
Puerto Rico (1)
Local Institution - 0143
San Juan
Romania (1)
Local Institution - 0220
Cluj-Napoca , Cluj
South Korea (1)
Local Institution - 0110
Seongdong-gu , Seoul
Spain (1)
Local Institution - 0038
Mérida , Badajoz
Sweden (1)
Local Institution - 0166
Gothenburg
Taiwan (1)
Local Institution - 0116
Kaohsiung City
Turkey (1)
Local Institution - 0035
Yenimahalle , Ankara
United Kingdom (1)
Local Institution - 0176
Southampton , Hampshire
United States (1)
Local Institution - 0228
Fullerton , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
11.09.2023
Completion date
16.11.2028
Registry ID
NCT05946941
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.