Study to assess the efficacy and safety of Deucravacitinib in adults with active Sjögren's syndrome

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, United States (ICTRP)

ID di studio ICTRP
NCT05946941 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Eine randomisierte, doppelblinde, placebokontrollierte Phase-III-Studie zur Beurteilung der Wirksamkeit und Sicherheit von Deucravacitinib bei Erwachsenen mit aktivem Sjögren-Syndrom (POETYK SjS-1) (BASEC)

Titolo accademico
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjgren's Syndrome (POETYK SjS-1) (ICTRP)

Titolo pubblico
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjgren's Syndrome (ICTRP)

Malattie studiate
Sjgren's Syndrome (ICTRP)

Intervento studiato
Drug: DeucravacitinibOther: Placebo (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione
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-Sjgren'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. (ICTRP)

non disponibile

Endpoint primari e secondari
Change from baseline in European League Against Rheumatism Sj�gren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 (ICTRP)

Change from baseline in European League Against Rheumatism Sj�gren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52;Number of participants with decrease in ESSPRI = 1 or 15% from baseline at Week 52;Number of participants with decrease in ESSDAI = 3 points from baseline at Week 52;Number of participants with ESSDAI < 5 at Week 52;Change from baseline in ESSDAI at Week 24;Change from baseline in stimulated whole salivary flow (SWSF) at Week 52;Change from baseline in physician global assessment (PhGA) at Week 52;Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52;Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52;Change from baseline in oral dryness NRS at Week 52;Change from baseline in joint/ muscle pain NRS at Week 52;Number of participants with an increase of Schirmer's test = 5 mm if abnormal baseline or no change of Schirmer's test to abnormal if baseline is normal;Number of participants with adverse events (AEs);Number of participants with serious AEs (SAEs);Number of participants with AEs leading to discontinuation of treatment and study discontinuation;Number of participants with AEs of special interest (AESIs);Number of participants with clinical laboratory abnormalities;Number of participants with electrocardiogram (ECG) abnormalities;Number of participants with vital sign abnormalities (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Bristol-Myers Squibb;BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, Clinical.Trials@bms.com, 855-907-3286, Bristol-Myers Squibb, (ICTRP)

ID secondari
2023-503327-26, U111-1289-6072, IM011-1069 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05946941 (ICTRP)