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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Plaque Psoriasis

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
Moderate to severe disease
Plaque psoriasis for at least 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 466 days
Awards & highlights

Study Summary

This trial is testing a new drug for plaque psoriasis in adolescents to see if it is safe and effective. The first part will test different doses to see what levels of the drug are safe and effective. The second part will test the long-term safety of the drug.

Who is the study for?
This trial is for kids and teens aged 4 to <18 with moderate to severe plaque psoriasis. They should be candidates for phototherapy or systemic therapy, have had psoriasis for at least 6 months, and not weigh less than the set limits. Those with other psoriasis types, recent infections, TB, or prior deucravacitinib use can't join.Check my eligibility
What is being tested?
The study tests Deucravacitinib's levels and effectiveness in young patients with plaque psoriasis. It has two parts: Part A finds the right doses; Part B checks how well these doses work. There's also a long-term part that looks at safety over five years.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from drugs like Deucravacitinib may include liver issues, infections due to immune system effects, headaches, nausea, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is moderate to severe.
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I have had plaque psoriasis for at least 6 months.
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I am between 12 and 17 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 466 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 466 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 2
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 2
Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16
+2 more
Secondary outcome measures
Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo
Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo
Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo
+35 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Active treatment deucravacitinib standard doseExperimental Treatment1 Intervention
Group II: Active treatment deucravacitinib half-standard doseExperimental Treatment1 Intervention
Group III: 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
4,129,911 Total Patients Enrolled

Media Library

Deucravacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04772079 — Phase 3
Plaque Psoriasis Research Study Groups: Active treatment deucravacitinib standard dose, Active treatment deucravacitinib half-standard dose, Placebo
Plaque Psoriasis Clinical Trial 2023: Deucravacitinib Highlights & Side Effects. Trial Name: NCT04772079 — Phase 3
Deucravacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04772079 — Phase 3

Frequently Asked Questions

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

How many people with the disease are being asked to participate in this test?

"The study requires 84 patients that fit the inclusion criteria. The sponsor, Bristol-Myers Squibb, has chosen Local Institution - 0008 in Calgary, Alberta and Local Institution - 0009 in Montréal, Quebec as two of the trial's locations."

Answered by AI

Do numerous hospitals in America offer this clinical trial to patients?

"Currently, this trial is operational in 5 hospitals. These include locations in Calgary, Montréal and Montreal as well as 2 other cities. If you enroll in the study, try to choose a location close to minimize travel requirements."

Answered by AI

What is the research history of BMS-986165?

"The first documented study of BMS-986165 was in 2018 at H-T. Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia. 34 clinical trials have completed since then with 11 more presently underway. A high concentration of these active studies are based in Calgary, Alberta."

Answered by AI

What are the desired outcomes of this experiment?

"The primary outcome of this study, which will be assessed two weeks after the start of the study period and compared at week 16, is the percentage of patients that see a 75% or greater improvement in their Psoriasis Area and Severity Index (PASI 75) scores. Additionally, this trial will compare BMS-986165 against placebo in terms of Steady-state trough observed plasma concentration (Ctrough) at Week 16, Proportion of subjects using topical corticosteroid at Week 16, and Change from baseline in PASI at Week 16."

Answered by AI

Is it dangerous to take BMS-986165?

"BMS-986165 has received a safety score of 3. This is because it has progressed to Phase 3 clinical trials, meaning that there is efficacy data as well as multiple rounds of supportive safety data."

Answered by AI

Are we currently looking for volunteers for this research?

"This study, which was initially posted on March 23rd 2021 according to clinicaltrials.gov, is seeking participants. The most recent update to the posting was on July 1st, 2022."

Answered by AI

Does this research project have an age limit?

"This particular trial is designed for patients aged 12 to 18. Out of the 33 trials taking place involving minors, this is one of 162 trials testing treatments on patients over 65 years old."

Answered by AI

Could you pre-screen me to see if I am able to join this experimental research?

"Children with plaque psoriasis that are between the ages of 12 and 18 can participate in this 84-person clinical trial."

Answered by AI

Have there been other similar medical studies in the past?

"Bristol-Myers Squibb first sponsored a clinical trial for BMS-986165 in 2018. After the successful Phase 1 study with 240 participants, the drug was approved for Phase 2 trials. 11 different ongoing medical studies are being conducted in 400 cities and 36 countries around the world."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Local Institution
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
2021. "A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04772079.
All > Psoriasis > Plaque Psoriasis
~37 spots leftby Apr 2025
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