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

NCT04772079 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: IM011-1262022-502519-13
• Study Type: interventional
• Target: 153
• Locations: 13 countries
• Sites: 63

Brief Summary

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in children and adolescent participants aged 4 to \<18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \<18 years) and Cohort 2 (age 4 to \<12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 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 children and adolescent participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in children and adolescent participants with psoriasis who have completed Parts A or B of the study.

Conditions

Plaque Psoriasis

Keywords

Adolescent Psoriasis; BMS-986165; Clinical trial; Deucravacitinib; Children Psoriasis; Pediatric Psoriasis; Plaque Psoriasis; Psoriasis

Outcome Measures

Primary Outcomes (10)

• Observed average concentration at steady state for deucravacitinib at Week 2

  Part A

  Week 2

• Maximum observed plasma concentration at steady state for deucravacitinib at Week 2

  Part A

  Week 2

• Trough observed plasma concentration for deucravacitinib at Week 2

  Part A

  Week 2

• Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16

  Part B

  Week 16

• Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16

  Part B

  Week 16

• Incidence of Adverse Events (AEs)

  Long-term extension (LTE) Period

  Up to 316 weeks

• Incidence of serious adverse events (SAEs)

  LTE Period

  Up to 316 weeks

• Monitoring of growth: Body weight

  LTE Period

  Up to 316 weeks

• Monitoring of growth: Height

  LTE Period

  Up to 316 weeks

• Monitoring of growth: Tanner staging (sexual maturation)

  LTE Period

  Up to 316 weeks

Secondary Outcomes (36)

• Incidence of Adverse Events (AEs)

  Up to Week 52

• Incidence of serious adverse events (SAEs)

  Up to Week 52

• Incidence of clinically significant changes in clinical laboratory results: Hematology tests

  Up to Week 52

• Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests

  Up to Week 52

• Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

  Up to Week 52

Study Arms (3)

Active treatment deucravacitinib standard dose

EXPERIMENTAL

Drug: Deucravacitinib

Active treatment deucravacitinib half-standard dose

EXPERIMENTAL

Drug: Deucravacitinib

Placebo

PLACEBO COMPARATOR

Other: Placebo matching deucravacitinib

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Active treatment deucravacitinib half-standard dose; Active treatment deucravacitinib standard dose

Placebo matching deucravacitinib OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males and females aged 12 to \<18 years for Cohort 1. Males and females aged 4 to \<12 years for Cohort 2.
• 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.

You may not qualify if:

• Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to \< 18 years), Part A and Part B. Participants weighing \< 18.0 kg at screening for Cohort 2 (age 4 to \< 12 years), Part A and Part B.
• Other forms of psoriasis.
• History of recent infection.
• Prior exposure to deucravacitinib (BMS-986165) or another active comparator.
• Evidence of active TB for LTE period.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (63)

Instituto de Neumonologia Y Dermatologia

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1425, Argentina

RECRUITING

Psoriahue

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425DKG, Argentina

RECRUITING

CONEXA Investigacion Clinica S.A.

Buenos Aires, 1012, Argentina

RECRUITING

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI, Argentina

RECRUITING

Hospital Italiano de Buenos Aires

CABA, 1199, Argentina

RECRUITING

Consultora Integral de Salud

Córdoba, 5004, Argentina

RECRUITING

The Skin Hospital

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Local Institution - 0002

Westmead, New South Wales, 2145, Australia

WITHDRAWN

Queensland Children's Hospital

Brisbane, Queensland, 4101, Australia

RECRUITING

Veracity Clinical Research

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

RECRUITING

Local Institution - 0001

Melbourne, Victoria, 3995, Australia

COMPLETED

Centro de Pesquisas da Clínica IBIS

Salvador, Estado de Bahia, 41820-020, Brazil

RECRUITING

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

RECRUITING

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP

Ribeirão Preto, São Paulo, 14051-140, Brazil

RECRUITING

Local Institution - 0083

Rio de Janeiro, 22470-220, Brazil

NOT YET RECRUITING

Local Institution - 0067

São Paulo, 05403-000, Brazil

WITHDRAWN

Local Institution - 0010

Calgary, Alberta, T2J 7E1, Canada

COMPLETED

Alberta Dermasurgery Centre

Edmonton, Alberta, T6G 1C3, Canada

RECRUITING

Local Institution - 0039

Hamilton, Ontario, L8N 1Y2, Canada

WITHDRAWN

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Centre Hospitalier de Calais

Calais, 62107, France

RECRUITING

Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology

Dijon, 21000, France

RECRUITING

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

Nice, 06202, France

RECRUITING

Local Institution - 0021

Paris, 75019, France

COMPLETED

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Universitätsmedizin Johannes Gutenberg Universität Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, 10117, Germany

RECRUITING

Kath. Kinderkrankenhaus Wilhelmstift

Hamburg, 22149, Germany

RECRUITING

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

RECRUITING

Fukuoka University Hospital

Fukuoka, Jonan-Ku, Fukuoka, 814-0180, Japan

RECRUITING

Local Institution - 0040

Isehara, Kanagawa, 259-1193, Japan

WITHDRAWN

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

RECRUITING

Teikyo University Hospital

Itabashi-ku, Tokyo, 173-8606, Japan

RECRUITING

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 160-0023, Japan

RECRUITING

Nippon Life Hospital

Osaka, 550-0006, Japan

RECRUITING

Crea de Guadalajara

Guadalajara, Jalisco, 44600, Mexico

RECRUITING

Grupo Clínico CATEI S.C.

Guadalajara, Jalisco, 44638, Mexico

RECRUITING

RM Pharma Specialists

Mexico City, Mexico City, 03100, Mexico

RECRUITING

Arké SMO S.A de C.V

Veracruz, 91910, Mexico

RECRUITING

Local Institution - 0011

Krakow, 30-438, Poland

COMPLETED

Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak

Lodz, 90-436, Poland

RECRUITING

Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii

Warsaw, 02-507, Poland

RECRUITING

WroMedica

Wroclaw, 51-620, Poland

RECRUITING

Local Institution - 0080

Bucharest, Bucharest, 012292, Romania

WITHDRAWN

Local Institution - 0081

Bucharest, Bucharest, 020125, Romania

WITHDRAWN

Local Institution - 0088

Bucharest, Bucharest, 020762, Romania

WITHDRAWN

CCBR Clinical Research

Bucharest, Bucharest, 30463, Romania

RECRUITING

Lotus-Med Tunari

Bucharest, 020528, Romania

RECRUITING

Spitalul clinic de urgenta pentru copii Sf. Maria

Iași, 700309, Romania

RECRUITING

Spitalul Clinic Judetean Mures

Târgu Mureş, 540342, Romania

RECRUITING

Local Institution - 0048

Seoul, Seoul-teukbyeolsi [Seoul], 02447, South Korea

COMPLETED

Local Institution - 0047

Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea

COMPLETED

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea

RECRUITING

Hospital General Universitario de Alicante-Dermatology

Alicante, 03010, Spain

RECRUITING

OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces-Dermatology

Barakaldo, 48903, Spain

RECRUITING

Hospital Sant Joan de Déu-URC Dermatology

Esplugues de Llobregat, 08950, Spain

RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología

Las Palmas de GC, 35019, Spain

RECRUITING

Hospital Universitario 12 de Octubre-DERMATOLOGY

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz-UCICEC/DERMA

Madrid, 28046, Spain

RECRUITING

Mounts Bay Medical

Connor Downs, TR27 5DT, United Kingdom

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: February 26, 2021
• Study Start: March 23, 2021
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): September 8, 2033
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

FR (4); JP (7); PL (4); DE (5); AR (6); BR (5); CA (5); RO (7); KR (3); AU (6); ME (4); GB (1); ES (6)