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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Psoriasis

Phase 4

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

Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.

Evidence of typical plaque psoriasis in a non-genital area at both screening visit and Day 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 16

Awards & highlights

Study Summary

This trial will test a drug to see if it can help people with psoriasis on their hands, feet, and genitals.

Who is the study for?

This trial is for adults with moderate-to-severe non-pustular palmoplantar and genital psoriasis, who have not improved with at least one topical therapy. Participants should have stable plaque psoriasis without significant flares or changes in the last 6 months and be suitable for phototherapy or systemic treatment.Check my eligibility

What is being tested?

The study tests deucravacitinib's safety and effectiveness against a placebo in treating non-pustular palmoplantar and genital psoriasis. It aims to see if this medication can help manage symptoms better than no active treatment.See study design

What are the potential side effects?

While specific side effects of deucravacitinib are not listed here, common side effects may include nausea, headaches, possible liver issues, infections due to immune system impact, and other drug-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My psoriasis is moderate to severe, with a score of 3 or more.

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I have visible psoriasis plaques outside the genital area.

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I have tried at least one skin cream or ointment without success or could not tolerate it.

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My psoriasis is moderate to severe, not pustular, with specific scores.

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I have visible psoriasis plaques on my body, excluding palms and soles.

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I have had stable genital psoriasis for at least 6 months.

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My genital psoriasis is rated moderate-to-severe by my doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Static Physician Global Assessment Genitals (s-PGA-G) Score of 0 (Clear ) or 1 (Almost Clear), With At Least a 2-Point Reduction

Number of Participants With a 75% Improvement in Palmoplantar Psoriasis Area and Severity Index (pp-PASI-75) Score

Secondary outcome measures

Change from baseline in Genital Psoriasis (GenPs) Itch Numeric Rating Scale (NRS) score

Number of Participants With Adverse Events (AEs)

Number of Participants With Clinical Laboratory Abnormalities

+4 more

Side effects data

From 2022 Phase 3 trial • 220 Patients • NCT04167462

18%

Upper respiratory tract infection

Mouth ulceration

Nasopharyngitis

Pruritus

Headache

Folliculitis

Psoriasis

Cholecystitis

Gastroenteritis shigella

Gastroenteritis

Pharyngitis

Diabetes mellitus

Accidental overdose

Hepatobiliary procedural complication

Psoriatic arthropathy

100%

80%

60%

40%

20%

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DeucravacitinibExperimental Treatment1 Intervention

Group II: Placebo followed by DeucravacitinibPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deucravacitinib

2021

Completed Phase 4

~160

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,129,704 Total Patients Enrolled

36 Trials studying Psoriasis

19,720 Patients Enrolled for Psoriasis

Frequently Asked Questions

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

Has Deucravacitinib been accorded sanction by the FDA?

"The safety of Deucravacitinib is rated 3 out of 3, as it has been approved and entered Phase 4 clinical trials."

Answered by AI

Is the recruitment of participants for this trial still ongoing?

"Clinicaltrials.gov confirms that this medical trial is no longer actively recruiting patients, despite originally being listed on September 15th 2023 and last updated a few days later. Although the recruitment period has ended for this particular study, there are still 160 other clinical trials looking for participants at present."

Answered by AI

In what localities can this clinical test be accessed?

"This research is recruiting participants at 25 medical sites in the United States, with notable locations being Los Angeles, Rockville and Detroit. To reduce your travel needs, select a clinical trial site closest to you."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

2023. "A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06042920.

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