Psoriasis
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Psoriasis
IM011-126 Enrolling

Plaque Psoriasis Trial for Teens (66 Weeks)


Age: 12 Years

Adolescents aged 12 to under 18 years old with stable plaque psoriasis for 6 months or more, may qualify to participate. Individuals must have moderate to severe plaque psoriasis and be able to swallow study medication. Teens with a medical history of JPsA (juvenile psoriatic arthritis) or who report symptoms suggestive of JPsA at screening, must have a confirmed diagnosis.

This study consists of 2 parts. In Part A, participants will receive investigational oral medication (active study drug) in tablet form. In Part B, participants will receive either active study drug or placebo for the first 16 weeks, followed by active study drug up to Week 52.  Study medication and study-related care will be provided at no cost. Reimbursement for study-related expenses will also be provided.

Study participation will last about 66 weeks in each part, and involve about 22 visits to the study centre in Part A, and 18 visits in Part B.


Official Title

A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Adolescent Subjects With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov ID

NCT04772079

Sponsor

Bristol-Myers Squibb

Study Description

  • Brief Summary:

    Bristol-Myers Squibb

  • Condition or Disease:

    Plaque Psoriasis

  • Intervention/Treatment:

    Drug: Deucravacitinib Drug: Deucravacitinib Other: Placebo matching deucravacitinib
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    12 Years and 18 Years (Child,Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Males and females aged 12 to <18 years
Plaque psoriasis for at least 6 months
Moderate to severe disease
Candidate for phototherapy or systemic therapy
Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period

Exclusion Criteria:

Weighing ≤ 30.0 kg at screening
Other forms of psoriasis
History of recent infection
Prior exposure to deucravacitinib (BMS-986165) or active comparator
Evidence of active TB for LTE period

Other protocol-defined inclusion/exclusion criteria apply


Participating Locations

COUNTRY
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Canada
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Australia

Participating Experts

Dr. Alim Devani

Dermatologist

Dr. Vimal Prajapati, MD, FRCPC, FAAD

Dermatologist

Dr. Charles Lynde MD, FRCPC

Dermatologist

Dr. Lynda Spelman

Dermatologist

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