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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506296-97-00
Acronym
IM011-1128
Enrollment
145
Registered
2025-10-08
Start date
2025-10-28
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Plaque Psoriasis

Brief summary

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.

Detailed description

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.

Interventions

DRUGPlacebo to match deucravacitinib 2mg minitablets in sachet
DRUGPlacebo to match deucravacitinib 6mg tablets in bottle
DRUGdeucravacitinib

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Belgium, Germany, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026