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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Sjögren's Syndrome (POETYK SjS-1 Trial)

Phase 3
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial tests a new drug to treat Sjögren's Syndrome in adults to see if it is safe and effective.

Who is the study for?
This trial is for adults with Active Sjögren's Syndrome who have had the disease for at least 16 weeks but no more than 10 years, and are experiencing moderate to severe symptoms. Participants must test positive for anti-Ro/SSA and meet specific criteria including a minimum salivary flow rate. Those previously treated with TYK2 inhibitors or having other autoimmune diseases besides SjS are excluded.
What is being tested?
The study is testing the safety and effectiveness of Deucravacitinib, comparing two different doses against a placebo in individuals with Active Sjögren's Syndrome. The goal is to determine if this medication can alleviate the condition's symptoms.
What are the potential side effects?
While not specified here, common side effects of drugs like Deucravacitinib may include infections, high blood pressure, liver enzyme changes, nausea, headaches, and possibly others depending on individual reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 2 trial • 67 Patients • NCT04877990
25%
COVID-19
13%
Pneumonia
13%
Nasopharyngitis
8%
Upper respiratory tract infection
8%
Cough
8%
Pyrexia
8%
Mouth ulceration
4%
Urinary tract infection
4%
Small intestinal obstruction
4%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
CROHN'S DISEASE
ULCERATIVE COLITIS

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Deucravacitinib, Dose 2Experimental Treatment1 Intervention
Group II: Deucravacitinib, Dose 1Experimental Treatment1 Intervention
Group III: Placebo, followed by Deucravacitinib Dose 1 or Dose 2Placebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucravacitinib
2021
Completed Phase 4
~160

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,682 Previous Clinical Trials
4,128,813 Total Patients Enrolled
3 Trials studying Sjögren's Syndrome
375 Patients Enrolled for Sjögren's Syndrome

Media Library

Deucravacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05946941 — Phase 3
Sjögren's Syndrome Research Study Groups: Deucravacitinib, Dose 1, Deucravacitinib, Dose 2, Placebo, followed by Deucravacitinib Dose 1 or Dose 2
Sjögren's Syndrome Clinical Trial 2023: Deucravacitinib Highlights & Side Effects. Trial Name: NCT05946941 — Phase 3
Deucravacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05946941 — Phase 3
~477 spots leftby Nov 2026
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