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

Plaque Psoriasis Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04772079
• Other study ID #: IM011-126
• Secondary ID: 2019-004879-39
• Status: Recruiting
• Phase: Phase 3
• Start date: March 23, 2021
• Est. completion date: September 8, 2033

Study information

• Verified date: February 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric 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 pediatric 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 pediatric participants with psoriasis who have completed Parts A or B of the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 153
• Est. completion date: September 8, 2033
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 active comparator

• Evidence of active TB for LTE period

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Deucravacitinib
Specified dose on specified days

Other:
• Placebo matching deucravacitinib
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Centro de Investigaciones Metabólicas (CINME)	Buenos Aires
Argentina	CONEXA Investigacion Clinica S.A.	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Caba
Argentina	Instituto de Neumonología Y Dermatología	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Psoriahue	Ciudad Autonoma de Buenos Aires	Buenos Aires
Australia	Local Institution - 0072	Brisbane	Queensland
Australia	Monash Health	Clayton	Victoria
Australia	The Skin Hospital	Darlinghurst	New South Wales
Australia	Local Institution - 0001	Melbourne	Victoria
Australia	Local Institution - 0002	Westmead	New South Wales
Australia	Veracity Clinical Research	Woolloongabba	Queensland
Brazil	Local Institution - 0064	Ribeirão Preto	São Paulo
Brazil	Local Institution - 0069	Salvador	Bahia
Brazil	Local Institution - 0067	São Paulo
Canada	Local Institution - 0010	Calgary	Alberta
Canada	Alberta Dermasurgery Centre	Edmonton	Alberta
Canada	Local Institution - 0039	Hamilton	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Local Institution - 0050	Toronto	Ontario
France	Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology	Dijon
France	Centre Hospitalier Universitaire de Nice - Hôpital l'Archet	Nice
France	Hopital Robert Debre	Paris
Germany	Local Institution - 0076	Berlin
Germany	Local Institution - 0073	Dresden	Sachsen
Germany	Local Institution - 0074	Hamburg
Germany	Local Institution - 0075	Mainz	Rheinland-Pfalz
Germany	Local Institution - 0077	Münster	Nordrhein-Westfalen
Japan	Local Institution - 0032	Fukuoka, Jonan-Ku	Fukuoka
Japan	Local Institution - 0040	Isehara	Kanagawa
Japan	Local Institution - 0034	Itabashi-ku	Tokyo
Japan	Local Institution - 0033	Nagoya	Aichi
Japan	Local Institution - 0035	Osaka
Japan	Local Institution - 0041	Shinjuku-ku	Tokyo
Japan	Local Institution - 0038	Tsu	Mie
Korea, Republic of	Local Institution - 0047	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Local Institution - 0048	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Local Institution - 0059	Seoul	Seoul-teukbyeolsi [Seoul]
Mexico	Centro de Atención en Enfermedades Inflamatorias CATEI	Guadalajara	Jalisco
Mexico	Local Institution - 0054	Guadalajara	Jalisco
Mexico	Local Institution - 0052	Mexico City	Distrito Federal
Mexico	Arké SMO S.A de C.V	Veracruz
Poland	Local Institution - 0011	Krakow
Poland	Local Institution - 0006	Lodz
Poland	Panstwowy Instytut Medyczny MSWiA-Klinika Dermatologii	Warsaw
Poland	WroMedica	Wroclaw
Romania	Local Institution - 0080	Bucharest	Bucure?ti
Romania	Local Institution - 0081	Bucuresti	Bucure?ti
Romania	Local Institution - 0082	Bucuresti	Bucure?ti
Romania	Local Institution - 0079	Iasi	Ia?i
Romania	Local Institution - 0078	Târgu Mure?	Mure?
Spain	Local Institution - 0017	Alicante
Spain	OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces-Dermatology	Barakaldo
Spain	Hospital Sant Joan de Déu-URC Dermatology	Esplugues de Llobregat
Spain	Local Institution - 0016	Las Palmas De GC
Spain	Hospital Universitario 12 de Octubre-DERMATOLOGY	Madrid
Spain	Hospital Universitario La Paz-UCICEC/DERMA	Madrid
United Kingdom	Local Institution - 0019	Connor Downs

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Argentina,  Australia,  Brazil,  Canada,  France,  Germany,  Japan,  Korea, Republic of,  Mexico,  Poland,  Romania,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 2	Part A	Week 2
Primary	Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 2	Part A	Week 2
Primary	Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 2	Part A	Week 2
Primary	Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16	Part B	Week 16
Primary	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
Primary	Incidence of Adverse Events (AEs)	Long-term extension (LTE) Period	Up to 316 weeks
Primary	Incidence of serious adverse events (SAEs)	LTE Period	Up to 316 weeks
Primary	Monitoring of growth: Body weight	LTE Period	Up to 316 weeks
Primary	Monitoring of growth: Height	LTE Period	Up to 316 weeks
Primary	Monitoring of growth: Tanner staging (sexual maturation)	LTE Period	Up to 316 weeks
Secondary	Incidence of Adverse Events (AEs)	Part A and Part B	Up to 424 days
Secondary	Incidence of serious adverse events (SAEs)	Part A and Part B	Up to 466 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Part A and Part B	Up to 466 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests	Part A and Part B	Up to 466 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests	Part A and Part B	Up to 466 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests	Part A and Part B	Up to 410 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Infectious serologies tests	Part A and Part B	Up to 42 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Tuberculosis (TB) tests	Part A and Part B	Up to 42 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests	Part A and Part B	Up to 368 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests	Part A and Part B	Up to 368 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests	Part A and Part B	Up to 368 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only	Part A and Part B	Up to 466 days
Secondary	Incidence of clinically significant changes in lymphocyte subsets and function	Part A and Part B	Up to 466 days
Secondary	Incidence of clinically significant changes in cytokine levels	Part A and Part B	Up to 466 days
Secondary	Incidence of clinically significant changes in physical examination findings	Part A and Part B	Up to 466 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature	Part A and Part B	Up to 466 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate	Part A and Part B	Up to 466 days
Secondary	Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure	Part A and Part B	Up to 466 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate	Part A and Part B	Up to 466 days
Secondary	Monitoring of growth: Body weight	Part A and Part B	Up to 466 days
Secondary	Monitoring of growth: Height	Part A and Part B	Up to 466 days
Secondary	Monitoring of growth: Tanner staging (sexual maturation)	Part A and Part B	Up to 466 days
Secondary	Proportion of subjects with at least 75% improvement in PASI (PASI 75) at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo	Part B	Week 16
Secondary	Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo	Part B	Week 16
Secondary	Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo	Part B	Week 16
Secondary	Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo	Part B	Week 16
Secondary	Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo	Part B	Week 16
Secondary	Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo	Part B	Week 16
Secondary	Change from baseline in subject reported visual analog scale (VAS) for subject's assessment of joint pain at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo	Part B	Week 16
Secondary	Change from baseline in VAS for subject's Global Assessment of Joint Disease; at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo	Part B	Week 16
Secondary	Proportion of subjects achieving American College of Rheumatology Pediatric 30 (ACR Pedi 30) response at Week 16 for subjects with confirmed JPsA prior to baseline	Part B; ACR Pedi 30 response is defined as subjects with at least 30% improvement from baseline in 3 of any 6 variables in the core set, while no more than one of the remaining variables can worsen by > 30% for comparison of deucravacitinib vs placebo	Week 16
Secondary	Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo	Part B	Week 16
Secondary	Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16	Part B	Week 16
Secondary	Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 16	Part B	Week 16
Secondary	Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 16	Part B	Week 16
Secondary	Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 16	Part B	Week 16
Secondary	Proportion of participants with 75% improvement in PASI (PASI 75) over time	LTE Period	Up to 316 weeks
Secondary	Proportion of participants with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline over time	LTE Period	Up to 316 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting