A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adol… (NCT06979453) | Clinical Trial Compass
RecruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
United States366 participantsStarted 2025-12-03
Plain-language 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
Who can participate
Age range12 Years – 17 Years
SexALL
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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.
\- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:.
i) Is not an individual of childbearing potential (IOCBP).
ii) Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.
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 D…
What they're measuring
1
Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Timeframe: At week 16
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
Timeframe: At week 16
Trial details
NCT IDNCT06979453
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2029-10-12
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com