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Janus Kinase (JAK) Inhibitor
Deucravacitinib for Psoriatic Arthritis
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
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.
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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
2,650 Previous Clinical Trials
4,130,182 Total Patients Enrolled
10 Trials studying Psoriatic Arthritis
12,108 Patients Enrolled for Psoriatic Arthritis
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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.
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