Overall trial status: Ongoing, recruiting
Trial title: A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Deucravacitinib in Adolescent Subjects (12 years to less than 18 years) with Moderate to Severe Plaque Psoriasis
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Germany:Ongoing, recruiting, Romania:Authorised, recruiting, Italy:Ongoing, recruiting, Belgium:Ongoing, recruiting, Poland:Ongoing, recruiting, Hungary:Ongoing, recruiting, Spain:Ongoing, recruiting
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Efficacy: Participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16., Efficacy: Participants achieving a sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16., Safety (LTE): AEs and SAEs through study completion., Safety (LTE): Monitoring of growth, including body weight and height and sexual maturation, through study completion.
Secondary end point: Efficacy: Participants achieving at least 90% improvement in PASI (PASI 90) Week 16., Efficacy: Change from baseline in PASI at Week 16., Efficacy: Change from baseline in BSA involvement at Week 16., Safety: Treatment emergent AEs and SAEs, laboratory parameters, physical examination, and vital signs through study completion., Safety: Participants with protective titers of antibodies to measles, tetanus, and pertussis at Week 16., Safety: Monitoring of growth including body weight and height, and sexual maturation through study completion., Efficacy (LTE): Participants achieving 75% improvement in PASI (PASI 75) over time through study completion., Efficacy (LTE): Participants achieving an sPGA score of 0 (clear) or 1(almost clear) with at least a 2-point reduction from baseline over time through study completion.
Age of participants: 0-17 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 145
Sponsor: Bristol-Myers Squibb Services Unlimited Company
Sponsor type: Pharmaceutical company
Trial product: Placebo to match deucravacitinib 2mg minitablets in sachet, oral use, Placebo to match deucravacitinib 6mg tablets in bottle, oral use, deucravacitinib, deucravacitinib
Results posted: No
Overall decision date: 08/10/2025
Countries decision date: BE: 08/10/2025, DE: 08/10/2025, HU: 10/10/2025, IT: 10/10/2025, RO: 13/10/2025, ES: 09/10/2025, PL: 10/10/2025
Last updated date: 13/10/2025
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