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

  • STATUS
    Recruiting
  • End date
    Sep 9, 2031
  • participants needed
    84
  • sponsor
    Bristol-Myers Squibb
Updated on 4 October 2022
Investigator
BMS Study Connect Contact Center www.BMSStudyConnect.com
Primary Contact
Local Institution (5.6 mi away) Contact
+14 other location

Summary

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in adolescent participants aged 12 to <18 years with moderate to severe plaque psoriasis. This study has two parts. Part A will evaluate the drug levels of BMS-986165 in adolescent participants ages 12 to <18 years to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in adolescents participants with moderate to severe plaque psoriasis.The long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in adolescent participants with psoriasis who have completed Parts A or B of the study.

Details
Condition Plaque Psoriasis
Treatment BMS-986165, Placebo matching BMS-986165, Deucravacitinib, Placebo matching deucravacitinib
Clinical Study IdentifierNCT04772079
SponsorBristol-Myers Squibb
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
Other protocol-defined inclusion/exclusion criteria apply
Prior exposure to deucravacitinib (BMS-986165) or active comparator
Evidence of active TB for LTE period
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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