A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
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| ClinicalTrials.gov Identifier: NCT04772079 |
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Recruitment Status :
Recruiting
First Posted : February 26, 2021
Last Update Posted : May 16, 2023
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Plaque Psoriasis | Drug: Deucravacitinib Other: Placebo matching deucravacitinib | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 153 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 23, 2021 |
| Estimated Primary Completion Date : | April 15, 2024 |
| Estimated Study Completion Date : | September 9, 2031 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Psoriasis
Drug Information available for:
Deucravacitinib
| Arm | Intervention/treatment |
|---|---|
| Experimental: Active treatment deucravacitinib standard dose |
Drug: Deucravacitinib
Specified dose on specified days |
| Experimental: Active treatment deucravacitinib half-standard dose |
Drug: Deucravacitinib
Specified dose on specified days |
| Placebo Comparator: Placebo |
Other: Placebo matching deucravacitinib
Specified dose on specified days |
Primary Outcome Measures :
- Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 2 [ Time Frame: Week 2 ]Part A
- Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 2 [ Time Frame: Week 2 ]Part A
- Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 2 [ Time Frame: Week 2 ]Part A
- Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16 [ Time Frame: Week 16 ]Part B
- 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 [ Time Frame: Week 16 ]Part B
- Incidence of Adverse Events (AEs) [ Time Frame: Up to 316 weeks ]Long-term extension (LTE) Period
- Incidence of serious adverse events (SAEs) [ Time Frame: Up to 316 weeks ]LTE Period
- Monitoring of growth: Body weight [ Time Frame: Up to 316 weeks ]LTE Period
- Monitoring of growth: Height [ Time Frame: Up to 316 weeks ]LTE Period
- Monitoring of growth: Tanner staging (sexual maturation) [ Time Frame: Up to 316 weeks ]LTE Period
Secondary Outcome Measures :
- Incidence of Adverse Events (AEs) [ Time Frame: Up to 424 days ]Part A and Part B
- Incidence of serious adverse events (SAEs) [ Time Frame: Up to 466 days ]Part A and Part B
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 466 days ]Part A and Part B
- Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [ Time Frame: Up to 466 days ]Part A and Part B
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 466 days ]Part A and Part B
- Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests [ Time Frame: Up to 410 days ]Part A and Part B
- Incidence of clinically significant changes in clinical laboratory results: Infectious serologies tests [ Time Frame: Up to 42 days ]Part A and Part B
- Incidence of clinically significant changes in clinical laboratory results: Tuberculosis (TB) tests [ Time Frame: Up to 42 days ]Part A and Part B
- Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests [ Time Frame: Up to 368 days ]Part A and Part B
- Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests [ Time Frame: Up to 368 days ]Part A and Part B
- Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests [ Time Frame: Up to 368 days ]Part A and Part B
- Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only [ Time Frame: Up to 466 days ]Part A and Part B
- Incidence of clinically significant changes in lymphocyte subsets and function [ Time Frame: Up to 466 days ]Part A and Part B
- Incidence of clinically significant changes in cytokine levels [ Time Frame: Up to 466 days ]Part A and Part B
- Incidence of clinically significant changes in physical examination findings [ Time Frame: Up to 466 days ]Part A and Part B
- Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 466 days ]Part A and Part B
- Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 466 days ]Part A and Part B
- Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure [ Time Frame: Up to 466 days ]Part A and Part B
- Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 466 days ]Part A and Part B
- Monitoring of growth: Body weight [ Time Frame: Up to 466 days ]Part A and Part B
- Monitoring of growth: Height [ Time Frame: Up to 466 days ]Part A and Part B
- Monitoring of growth: Tanner staging (sexual maturation) [ Time Frame: Up to 466 days ]Part A and Part B
- 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 [ Time Frame: Week 16 ]Part B
- 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 [ Time Frame: Week 16 ]Part B
- Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo [ Time Frame: Week 16 ]Part B
- Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo [ Time Frame: Week 16 ]Part B
- Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo [ Time Frame: Week 16 ]Part B
- Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo [ Time Frame: Week 16 ]Part B
- 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 [ Time Frame: Week 16 ]Part B
- 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 [ Time Frame: Week 16 ]Part B
- 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 [ Time Frame: Week 16 ]
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
- Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo [ Time Frame: Week 16 ]Part B
- Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16 [ Time Frame: Week 16 ]Part B
- Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 16 [ Time Frame: Week 16 ]Part B
- Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 16 [ Time Frame: Week 16 ]Part B
- Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 16 [ Time Frame: Week 16 ]Part B
- Proportion of participants with 75% improvement in PASI (PASI 75) over time [ Time Frame: Up to 316 weeks ]LTE Period
- 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 [ Time Frame: Up to 316 weeks ]LTE Period
Information from the National Library of Medicine
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| Ages Eligible for Study: | 4 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 ≤ 13.0 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772079
Contacts
| Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com | 855-907-3286 | Clinical.Trials@bms.com | |
| Contact: First line of the email MUST contain NCT # and Site #. |
Locations
Show 43 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT04772079 |
| Other Study ID Numbers: |
IM011-126 2019-004879-39 ( EudraCT Number ) |
| First Posted: | February 26, 2021 Key Record Dates |
| Last Update Posted: | May 16, 2023 |
| Last Verified: | May 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bristol-Myers Squibb:
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Adolescent Psoriasis BMS-986165 Clinical trial Deucravacitinib |
Pediatric Pediatric Psoriasis Plaque Psoriasis Psoriasis |
Additional relevant MeSH terms:
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases Deucravacitinib |
Dermatologic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |