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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 week 160
Awards & highlights

POETYK SjS-1 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.Check my eligibility
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.See study design
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.

POETYK SjS-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 160
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 160 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52
Secondary outcome measures
Change from baseline in ESSDAI at Week 24
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52
Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52
+15 more

Side effects data

From 2022 Phase 3 trial • 220 Patients • NCT04167462
18%
Upper respiratory tract infection
8%
Mouth ulceration
7%
Nasopharyngitis
5%
Pruritus
5%
Headache
3%
Folliculitis
3%
Psoriasis
1%
Cholecystitis
1%
Gastroenteritis shigella
1%
Gastroenteritis
1%
Pharyngitis
1%
Diabetes mellitus
1%
Accidental overdose
1%
Hepatobiliary procedural complication
1%
Psoriatic arthropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Week 0 up to Week 16
BMS-986165 Week 0 up to Week 52
BMS-986165 Week 16 up to Week 52

POETYK SjS-1 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
2,641 Previous Clinical Trials
4,129,308 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple venues running this research endeavor?

"This trial is being administered in 16 distinct areas, including Local Institution - 0211 (located in Nishinomiya-shi), and Institute for Rheumatic & Autoimmune Diseases, Overlook Medical Center located in Summit. The other locations are fewer but no less important."

Answered by AI

Are recruits currently being accepted for this experimental trial?

"This study, posted on August 8th 2023 and last edited July 7th 2023, is not recruiting new patients. Nevertheless there are numerous other clinical trials seeking participants at this present moment in time."

Answered by AI

Has the initial dosage of Deucravacitinib obtained its necessary regulatory authorization?

"Clinical data has suggested that Deucravacitinib, Dose 1 is safe to use in humans, thusly it was given a rating of 3. This drug's efficacy and safety have both been tested multiple times as it goes through Phase 3 clinical trials."

Answered by AI

Who else is applying?

What site did they apply to?
Institute for Rheumatic & Autoimmune Diseases, Overlook Medical Center
Local Institution - 0218
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
2023. "A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05946941.
All > Albuquerque > Spokane
~504 spots leftby Nov 2026
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