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

Phase 3

Not yet recruiting

• Conditions: Plaque Psoriasis
• Interventions: Drug: Deucravacitinib; Other: Placebo

• Registration Number: NCT06979453
• Lead Sponsor: Bristol-Myers Squibb

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-08-26
• Primary Completion: 2029-10-12
• Study Completion: 2034-08-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Administration of Deucravacitinib	Deucravacitinib	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)	At week 16
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	At week 16

Secondary Outcome Measures

Name	Time	Method
Number of participants achieving at least 90% improvement in PASI (PASI 90)	At week 16
Change from baseline in PASI	At week 16
Change from baseline in body surface area (BSA) involvement	At week 16
Change from baseline in worst itch numeric rating scale (WI-NRS)	At week 16
Number of participants achieving ≥ 4 improvement from baseline in the WI-NRS score (in participants with baseline score ≥ 4)	At week 16
Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score	At week 16
Number of participants achieving CDLQI 0/1 (among participants with a baseline CDLQI score ≥ 2)	At week 16
Number of participants with treatment emergent adverse events	Up to 5 years
Number of participants with serious adverse events	Up to 5 years
Number of participants with clinically significant changes in laboratory parameters	Up to 5 years
Number of participants with clinically significant changes in physical examinations	Up to 5 years
Number of participants with protective titers of antibodies to tetanus	At week 16
Number of participants with protective titers of antibodies to pertussis	At week 16
Number of participants with clinically significant changes in vital signs	Up to 5 years
Number of participants with protective titers of antibodies to measles	At week 16
Body weight	Up to 5 years
Height	Up to 5 years
Sexual maturation	Up to 5 years

Trial Locations

Locations (58)

Local Institution - 0025; 🇺🇸 Fountain Valley, California, United States

Local Institution - 0070; 🇺🇸 Tampa, Florida, United States

Local Institution - 0202; 🇺🇸 Metairie, Louisiana, United States

Local Institution - 0220; 🇺🇸 Marlborough, Massachusetts, United States

Local Institution - 0095; 🇺🇸 Dearborn, Michigan, United States

Local Institution - 0233; 🇺🇸 Columbia, Missouri, United States

Local Institution - 0235; 🇺🇸 Goodlettsville, Tennessee, United States

Local Institution - 0033; 🇺🇸 San Antonio, Texas, United States

Local Institution - 0154; 🇦🇷 Buenos Aires, Argentina

Local Institution - 0090; 🇺🇸 Fremont, California, United States

Local Institution - 0243; 🇺🇸 Walnut Creek, California, United States

Local Institution - 0214; 🇺🇸 Northridge, California, United States

Local Institution - 0077; 🇺🇸 Sacramento, California, United States

Local Institution - 0021; 🇺🇸 Clearwater, Florida, United States

Local Institution - 0231; 🇺🇸 Wheat Ridge, Colorado, United States

Local Institution - 0185; 🇺🇸 Margate, Florida, United States

Local Institution - 0014; 🇺🇸 Miami Lakes, Florida, United States

Local Institution - 0234; 🇺🇸 Hickory, North Carolina, United States

Local Institution - 0052; 🇺🇸 Las Vegas, Nevada, United States

Local Institution - 0045; 🇺🇸 Norfolk, Virginia, United States

Local Institution - 0149; 🇦🇷 Buenos Aires, Argentina

Local Institution - 0207; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

Local Institution - 0115; 🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0119; 🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0209; 🇧🇪 Brussels, Bruxelles-Capitale, Région De, Belgium

Local Institution - 0210; 🇧🇪 Brussels, Bruxelles-Capitale, Région De, Belgium

Local Institution - 0137; 🇧🇷 Salvador, Bahia, Brazil

Local Institution - 0107; 🇨🇦 Calgary, Alberta, Canada

Local Institution - 0221; 🇦🇷 Buenos Aires, Argentina

Local Institution - 0241; 🇨🇦 Edmonton, Alberta, Canada

Local Institution - 0136; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Local Institution - 0164; 🇨🇦 Winnipeg, Manitoba, Canada

Local Institution - 0242; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

Local Institution - 0240; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0142; 🇨🇦 Montréal, Quebec, Canada

Local Institution - 0124; 🇨🇴 Medellín, Antioquia, Colombia

Local Institution - 0222; 🇨🇳 Beijing, Beijing, China

Local Institution - 0227; 🇨🇳 Zhengzhou, Henan, China

Local Institution - 0224; 🇨🇳 Hangzhou, Zhejiang, China

Local Institution - 0167; 🇨🇴 Barranquilla, Atlántico, Colombia

Local Institution - 0125; 🇨🇴 Bogota, Cundinamarca, Colombia

Local Institution - 0195; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Local Institution - 0194; 🇩🇪 Mainz, Rheinland-Pfalz, Germany

Local Institution - 0211; 🇩🇪 Berlin, Germany

Local Institution - 0204; 🇩🇪 Dresden, Germany

Local Institution - 0193; 🇩🇪 Erlangen, Germany

Local Institution - 0153; 🇭🇺 Budapest, Hungary

Local Institution - 0155; 🇲🇽 Monterrey, Nuevo León, Mexico

Local Institution - 0237; 🇲🇽 Puebla, Mexico

Local Institution - 0212; 🇵🇱 Warsaw, Mazowieckie, Poland

Local Institution - 0103; 🇵🇱 Bialystok, Podlaskie, Poland

Local Institution - 0008; 🇵🇷 Caguas, Puerto Rico

Local Institution - 0249; 🇷🇴 Bucharest, București, Romania

Local Institution - 0174; 🇷🇴 Bucuresti, București, Romania

Local Institution - 0213; 🇷🇴 Bucuresti, București, Romania

Local Institution - 0218; 🇪🇸 Esplugues de Llobregat, Barcelona [Barcelona], Spain

Local Institution - 0216; 🇪🇸 Madrid, Spain

Local Institution - 0197; 🇪🇸 Santiago de Compostela, Spain