A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-17
SponsorBristol-Myers Squibb

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have stable plaque psoriasis for 6 months or more prior to Screening.

Participants must have moderate to severe psoriasis defined by:.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Deucravacitinib

    Drug

    Specified dose on specified days

  • Placebo

    Other intervention

    Specified dose on specified days

Treatment groups

366 Participants
are divided into 2 treatment groups
Group A: Administration of DeucravacitinibActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)

Time frame
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

Time frame
At week 16

Secondary outcomes

1

Number of participants achieving at least 90% improvement in PASI (PASI 90)

Time frame
At week 16
2

Change from baseline in PASI

Time frame
At week 16
3

Change from baseline in body surface area (BSA) involvement

Time frame
At week 16
4

Change from baseline in worst itch numeric rating scale (WI-NRS)

Time frame
At week 16

Other outcomes

Sponsors and contacts

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