Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults with Active Sjogren's Syndrome

JRCT ID: jRCT2031230582

Registered date:22/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Active Sjogren's Syndrome
• Date of first enrollment: 22/01/2024
• Target sample size: 45
• Countries of recruitment: United States,Japan,Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Colombia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Mexico,Japan,Netherlands,Japan,Peru,Japan,Poland,Japan,Portugal,Japan,South Korea,Japan,Romania,Japan,Spain,Japan,Switzerland,Japan,Sweden,Japan,Taiwan,Japan,Turkey etc.,Japan
• Study type: Interventional
• Intervention(s): Ducravacitinib is administered orally at a dosage of 3 mg or 6 mg twice daily.

Outcome(s)

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

Secondary Outcome

Change from baseline in European League Against Rheumatism Sjogren'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 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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-Sjogren's syndrome-associated antigen A (anti-Ro/SSA) at screening.

Exclude criteria

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.

Related Information

• Primary Sponsor: Sreih Antoine