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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
Must not have
Prior exposure to deucravacitinib (BMS-986165) or active comparator
Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to < 18 years), Part A and Part B. Participants weighing ≤ 13.0 kg at screening for Cohort 2 (age 4 to < 12 years), Part A and Part B.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 466 days
Awards & highlights
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.
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.
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 belowSelect...
My condition is moderate to severe.
Select...
I have had plaque psoriasis for at least 6 months.
Select...
I am between 12 and 17 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously been treated with deucravacitinib.
Select...
I weigh ≤ 30.0 kg and am aged 12-17, or weigh ≤ 13.0 kg and am aged 4-11.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 466 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 466 days
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 moreSecondary 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 moreTrial 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
2,677 Previous Clinical Trials
4,126,812 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is moderate to severe.I have a type of psoriasis.I have previously been treated with deucravacitinib.I am between 12 and 18 years old for Cohort 1, or between 4 and 12 years old for Cohort 2.I have had a recent infection.I have finished 52 weeks of treatment in either Part A or B for a long-term study.I have had plaque psoriasis for at least 6 months.I have active tuberculosis.I weigh ≤ 30.0 kg and am aged 12-17, or weigh ≤ 13.0 kg and am aged 4-11.I am between 12 and 17 years old.I am eligible for light-based or drug treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Active treatment deucravacitinib standard dose
- Group 2: Active treatment deucravacitinib half-standard dose
- Group 3: 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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