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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.
Must not have
Has non-plaque psoriasis (for PP pustulosis, PP pustular psoriasis, isolated pustules on palms or soles with or without erythema outside psoriatic plaques, guttate, pustular, erythrodermic, and drug-induced psoriasis) at screening or Day 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
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.
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.
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 belowSelect...
My psoriasis is moderate to severe, with a score of 3 or more.
Select...
I have visible psoriasis plaques outside the genital area.
Select...
I have tried at least one skin cream or ointment without success or could not tolerate it.
Select...
My psoriasis is moderate to severe, not pustular, with specific scores.
Select...
I have visible psoriasis plaques on my body, excluding palms and soles.
Select...
I have had stable genital psoriasis for at least 6 months.
Select...
My genital psoriasis is rated moderate-to-severe by my doctor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a type of psoriasis that is not plaque psoriasis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2023 Phase 2 trial • 67 Patients • NCT0487799025%
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
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,682 Previous Clinical Trials
4,129,209 Total Patients Enrolled
37 Trials studying Psoriasis
19,865 Patients Enrolled for Psoriasis
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