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)

Conditions

Sjogren's syndrome

Brief summary

Change from baseline in ESSDAI at Week 52

Detailed description

Change from baseline in ESSPRI at Week 52, Proportion of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52, Proportion of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52, Proportion of participants with ESSDAI < 5 at Week 52, Change from baseline in ESSDAI at Week 24, Change from baseline in SWSF at Week 52, Change from baseline in PhGA at Week 52, Change from baseline in FACIT-Fatigue at Week 52, Change from baseline in ocular dryness 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, Incidence of AEs, SAEs, AEs leading to discontinuation of treatment and study discontinuation, and target AEIs; change in laboratory, ECG, and vital signs; and abnormalities in laboratory, ECG, and vital signs, Proportion of participants with increase of Schirmer's test ≥ 5 mm if abnormal baseline or No change of Schirmer's test to abnormal if normal baseline at Week 52

Related papers

No related papers found yet.

Interventions

DRUGdeucravacitinib

DRUGDeucravacitinib placebo 3 mg film-coated tablets oral use

DRUGDeucravacitinib placebo 6 mg film-coated tablets oral use

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in ESSDAI at Week 52	—

Secondary

Measure	Time frame
Change from baseline in ESSPRI at Week 52, Proportion of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52, Proportion of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52, Proportion of participants with ESSDAI < 5 at Week 52, Change from baseline in ESSDAI at Week 24, Change from baseline in SWSF at Week 52, Change from baseline in PhGA at Week 52, Change from baseline in FACIT-Fatigue at Week 52, Change from baseline in ocular dryness 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, Incidence of AEs, SAEs, AEs leading to discontinuation of treatment and study discontinuation, and target AEIs; change in laboratory, ECG, and vital signs; and abnormalities in laboratory, ECG, and vital signs, Proportion of participants with increase of Schirmer's test ≥ 5 mm if abnormal baseline or No change of Schirmer's test to abnormal if normal baseline at Week 52	—

Measure

Time frame

Change from baseline in ESSPRI at Week 52, Proportion of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52, Proportion of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52, Proportion of participants with ESSDAI < 5 at Week 52, Change from baseline in ESSDAI at Week 24, Change from baseline in SWSF at Week 52, Change from baseline in PhGA at Week 52, Change from baseline in FACIT-Fatigue at Week 52, Change from baseline in ocular dryness 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, Incidence of AEs, SAEs, AEs leading to discontinuation of treatment and study discontinuation, and target AEIs; change in laboratory, ECG, and vital signs; and abnormalities in laboratory, ECG, and vital signs, Proportion of participants with increase of Schirmer's test ≥ 5 mm if abnormal baseline or No change of Schirmer's test to abnormal if normal baseline at Week 52

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Countries

Austria, Belgium, Bulgaria, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed