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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 week 156
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of deucravacitinib to a placebo in people with active psoriatic arthritis who have never taken a biologic disease modifying antirheumatic drug or who have previously taken a TNFα inhibitor.

Who is the study for?
This trial is for people with active Psoriatic Arthritis (PsA) who are either new to biologic treatments or have tried TNFα inhibitors before. They must have had PsA for at least 3 months, with ≥3 swollen and tender joints, an active psoriasis skin lesion or a history of plaque psoriasis, and meet specific medical criteria. Those with non-plaque psoriasis types, other joint diseases like rheumatoid arthritis, fibromyalgia, or certain autoimmune conditions cannot join.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Deucravacitinib compared to a placebo in treating Psoriatic Arthritis. Participants will be randomly assigned to receive either Deucravacitinib or a placebo. The trial includes those new to biologic drugs as well as patients previously treated with TNFα inhibitors.See study design
What are the potential side effects?
While the specific side effects of Deucravacitinib aren't listed here, similar medications can cause immune system changes leading to infections, liver issues, blood problems, potential risk of cancerous growths due to altered immunity response among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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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I have active arthritis with at least 3 swollen and 3 tender joints.
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I have active psoriasis or a history of it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 156
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 156 for reporting.

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% (ACR20)
Secondary outcome measures
Change from baseline Disease Activity Score 28 with C-Reactive Protein (DAS28-CRP)
Change from baseline Health Assessment Questionnaire - Disability Index (HAQ-DI)
Change from baseline Short Form-36 Physical Component Survey (SF-36 PCS) score
+40 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: DeucravacitinibExperimental Treatment1 Intervention
Group II: ApremilastExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apremilast
2017
Completed Phase 4
~2500
Deucravacitinib
2021
Completed Phase 4
~160

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,127,814 Total Patients Enrolled
10 Trials studying Psoriatic Arthritis
12,058 Patients Enrolled for Psoriatic Arthritis

Media Library

Deucravacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04908189 — Phase 3
Psoriatic Arthritis Research Study Groups: Deucravacitinib, Placebo, Apremilast
Psoriatic Arthritis Clinical Trial 2023: Deucravacitinib Highlights & Side Effects. Trial Name: NCT04908189 — Phase 3
Deucravacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04908189 — Phase 3
Psoriatic Arthritis Patient Testimony for trial: Trial Name: NCT04908189 — Phase 3

Frequently Asked Questions

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

Are there any slots still open for new participants in this experiment?

"That is correct, according to the information available on clinicaltrials.gov. The trial was posted on 7/15/2021 and was last updated on 10/21/2022. They are looking for a total of 700 participants at 46 different sites."

Answered by AI

What is the precedent for using Deucravacitinib in medical research?

"The first deucravacitinib study was completed in 2014 at Attikon Hospital. As of now, there have been a total of 18314 studies completed with 24 more presently recruiting patients. These clinical trials are situated mostly in Baton Rouge, Louisiana."

Answered by AI

How many patients are allowed to participate in this research?

"To carry out this study, we need 700 participants that meet the necessary requirements. The sponsor, Bristol-Myers Squibb, will run the trial from different locations, for example Ochsner Medical Complex - The Grove in Baton Rouge, Louisiana and Local Institution - 0111 in Vancouver, British Columbia."

Answered by AI

When might Deucravacitinib be available for general use?

"Deucravacitinib's Phase 3 status indicates that while the drug has not been comprehensively tested, initial studies have been promising and subsequent rounds of testing have reaffirmed its safety. Therefore, our team rates it as a 3."

Answered by AI

Deucravacitinib is most often employed for which medical conditions?

"Deucravacitinib is most often used to ulcers, but it can also aid in the management of psoriasis, behcet's syndrome, and severe plaque psoriasis."

Answered by AI

Across how many states is this research being conducted?

"Currently, this research is being conducted in 47 different locations, including but not limited to Baton Rouge, Vancouver, and Oklahoma City. To help reduce participant burden, it is crucial to pick a location near you."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Mississippi
Michigan
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I've tried other drugs that didn't work and am hopeful about TYK2 inhibitors.
PatientReceived no prior treatments
I have been diagnosed with Lyme disease and I have horrible arthritis pain but can’t remember if was diagnosed with Lyme arthritis.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
2021. "A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04908189.
All > Arthritis > Otezla
~187 spots leftby Apr 2025
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