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Janus Kinase (JAK) Inhibitor
Deucravacitinib for Psoriatic Arthritis
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
Must have completed the week 52 treatment for the optional open-label long-term extension period
Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 156 weeks
Awards & highlights
Study Summary
This trial will compare the effectiveness of a new drug to placebo in people with psoriatic arthritis who have not yet tried biologic drugs. The trial will also provide long-term safety data.
Who is the study for?
This trial is for individuals with active psoriatic arthritis who haven't used biologic disease-modifying anti-rheumatic drugs. They should have at least 3 swollen and tender joints, a diagnosis of PsA for 3+ months, an active skin lesion or history of plaque psoriasis, and certain levels of inflammation markers in their blood.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Deucravacitinib compared to a placebo in treating psoriatic arthritis. Participants will be randomly assigned to receive either the drug or placebo to assess long-term effects.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with similar medications include liver issues, infections due to weakened immune systems, nausea, headaches, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have finished a year-long treatment in a previous study phase.
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I have been diagnosed with psoriatic arthritis for at least 3 months.
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My X-rays show at least one erosion in my hand or foot joints due to PsA.
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I have active arthritis with at least 3 swollen and 3 tender joints.
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I have been diagnosed with Psoriatic Arthritis.
Select...
I have active psoriasis or a history of it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 156 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 156 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response
Secondary outcome measures
Change from baseline in DAS28-CRP score
Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score
Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score
+53 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DeucravacitinibExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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
4,129,414 Total Patients Enrolled
10 Trials studying Psoriatic Arthritis
12,108 Patients Enrolled for Psoriatic Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune condition like lupus or multiple sclerosis.I have finished a year-long treatment in a previous study phase.I have or had joint inflammation not caused by PsA, like gout or rheumatoid arthritis.I do not have plaque psoriasis currently.I have been diagnosed with psoriatic arthritis for at least 3 months.My X-rays show at least one erosion in my hand or foot joints due to PsA.I have taken approved or experimental drugs for Psoriatic Arthritis or Psoriasis.I have active arthritis with at least 3 swollen and 3 tender joints.I have been diagnosed with Psoriatic Arthritis.I have been diagnosed with active fibromyalgia.I have active psoriasis or a history of it.
Research Study Groups:
This trial has the following groups:- Group 1: Deucravacitinib
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there numerous research facilities testing this hypothesis within our borders?
"To make participation more convenient for volunteers, this clinical trial is enrolling patients at 47 sites located in or near Allen, Fullerton, Orland Park, and other cities."
Answered by AI
What severe side effects have been experienced by people who take Deucravacitinib?
"Deucravacitinib's safety is well-documented, as it has progressed to Phase 3 clinical trials."
Answered by AI
Are researchers still seeking participants for this trial?
"This study is currently seeking participants, as reported on clinicaltrials.gov. The clinical trial was originally posted on 7/13/2021 and was last edited on 10/25/2022."
Answered by AI
Are there other examples of Deucravacitinib research?
"Deucravacitinib was first studied in 2018 at Local Institution - 0198. There have been a total of 18267 completed trials since then. Right now, there are 11 active studies, and many of them are based in Allen, Texas."
Answered by AI
Are there other similar ongoing studies?
"There are 11 ongoing trials for Deucravacitinib in 398 cities and 36 countries. The first trial, sponsored by Bristol-Myers Squibb, was completed in 2018 and involved 240 patients. Since then, 18267 studies have been conducted."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Kaiser Permanente-Rheumatology
How many prior treatments have patients received?
3+
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