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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

Pivotal Trial

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with deucravacitinib.

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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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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Secondary study objectives

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

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