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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Psoriasis (POETYK PSO-LTE Trial)

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women must not be pregnant, lactating, or breastfeeding
Be older than 18 years old
Must not have
Participant must not have active signs or symptoms of tuberculosis (TB) as judged by the investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will study the long-term safety and effectiveness of the drug Deucravacitinib in people who have previously taken it for psoriasis in a different trial.

Who is the study for?
This trial is for people who have completed a prior Phase 3 study of BMS-986165 for moderate-to-severe psoriasis. Women participants should not be pregnant, breastfeeding, or lactating. Individuals with any condition that could interfere with the study or those showing active symptoms of tuberculosis are excluded.
What is being tested?
The focus is on Deucravacitinib (BMS-986165), assessing its long-term safety and effectiveness in individuals who've previously taken part in a related Phase 3 trial for treating psoriasis.
What are the potential side effects?
While specific side effects aren't listed here, they may include typical drug reactions such as skin irritation at the application site, headaches, nausea, and potential immune system impacts since it's being used to treat psoriasis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not pregnant, lactating, or breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any signs or symptoms of tuberculosis.

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 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%
Pharyngitis
1%
Gastroenteritis
1%
Cholecystitis
1%
Gastroenteritis shigella
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BMS-986165Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986165
2020
Completed Phase 3
~2990

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,097,619 Total Patients Enrolled
39 Trials studying Psoriasis
20,056 Patients Enrolled for Psoriasis

Media Library

Deucravacitinib (BMS-986165) (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04036435 — Phase 3
Psoriasis Research Study Groups: BMS-986165
Psoriasis Clinical Trial 2023: Deucravacitinib (BMS-986165) Highlights & Side Effects. Trial Name: NCT04036435 — Phase 3
Deucravacitinib (BMS-986165) (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04036435 — Phase 3
~332 spots leftby Jul 2026
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