POETYK-PsO-Ped

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis

Condition or Disease

Psoriasis

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	366
Primary Outcome Measures	1. Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) 2. Number of participants achieving a static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline
Actual Study Start Date:	November 2025
Estimated Primary Completion Date:	October 2029

Eligibility Criteria

Ages Eligible for Study:	12 to 17 Years Old
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Psoriasis

Inclusion Criteria

Participants must have stable plaque psoriasis for 6 months or more prior to Screening
Participants must have moderate to severe psoriasis defined by:
i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1
ii) Static Physician’s Global Assessment (sPGA) ≥ 3, at screening visit and Day 1
iii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1

Exclusion Criteria

Participants must not weigh < 30.0 kg at Screening and Day 1
Participants must not have non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) or any skin condition other than plaque psoriasis that could interfere with assessments of treatment effect at Screening or Day 1
Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1
Participants must not have any untreated bacterial infection within 60 days prior to Day 1
Participants must not have any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis)
Participants must not have herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions
Participants must not have received live vaccines or BCG within 60 days prior to Day 1 or plans to receive a live vaccine during the study, or within 60 days after completing study intervention
Participants must not have had any prior exposure to deucravacitinib

ADDITIONAL DETAILS

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