Deucravacitinib for Plaque Psoriasis

(POETYK-PsO-Ped Trial)

Recruiting at 60 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Disqualifiers: Non-plaque psoriasis, Serious infections, Cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

366 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

Adolescents with moderate to severe plaque psoriasis are eligible for this trial. Specific inclusion and exclusion criteria details were not provided, but typically these would cover health status, previous treatments, and other medical conditions that could affect the study's results.

Inclusion Criteria

My psoriasis is moderate to severe, covering more than 10% of my body.

My plaque psoriasis has been stable for at least 6 months.

I am not pregnant or breastfeeding and follow specific birth control measures.

Exclusion Criteria

I weigh at least 30 kg.

I only have plaque psoriasis with no other skin conditions.

I haven't had cancer or related diseases in the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Deucravacitinib or placebo to evaluate efficacy, safety, and drug levels

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Deucravacitinib

Trial Overview The trial is testing Deucravacitinib (BMS-986165), a medication intended for plaque psoriasis treatment in adolescents. Participants will either receive Deucravacitinib or a placebo to compare effectiveness and safety.

Participant Groups

Group I: Administration of Deucravacitinib Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania