Plaque Psoriasis
Conditions
Keywords
Adolescent Psoriasis, BMS-986165, Clinical trial, Deucravacitinib, Children Psoriasis, Pediatric Psoriasis, Plaque Psoriasis, Psoriasis
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.
Interventions
DRUGDeucravacitinib
Specified dose on specified days
OTHERPlacebo matching deucravacitinib
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
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 another active comparator. * Evidence of active TB for LTE period. * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed average concentration at steady state for deucravacitinib at Week 2 | Week 2 | Part A |
| Maximum observed plasma concentration at steady state for deucravacitinib at Week 2 | Week 2 | Part A |
| Trough observed plasma concentration for deucravacitinib at Week 2 | Week 2 | Part A |
| Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16 | 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 | Week 16 | Part B |
| Incidence of Adverse Events (AEs) | Up to 316 weeks | Long-term extension (LTE) Period |
| Incidence of serious adverse events (SAEs) | Up to 316 weeks | LTE Period |
| Monitoring of growth: Body weight | Up to 316 weeks | LTE Period |
| Monitoring of growth: Height | Up to 316 weeks | LTE Period |
| Monitoring of growth: Tanner staging (sexual maturation) | Up to 316 weeks | LTE Period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to Week 52 | Part A and Part B |
| Incidence of serious adverse events (SAEs) | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in lymphocyte subsets and function | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in cytokine levels | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in physical examination findings | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure | Up to Week 52 | Part A and Part B |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to Week 52 | Part A and Part B |
| Monitoring of growth: Body weight | Up to Week 52 | Part A and Part B |
| Monitoring of growth: Height | Up to Week 52 | Part A and Part B |
| Monitoring of growth: Tanner staging (sexual maturation) | Up to Week 52 | 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 | 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 | 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 | Week 16 | Part B |
| Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo | Week 16 | Part B |
| Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo | Week 16 | Part B |
| Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo | 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 | 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 | Week 16 | Part B |
| Proportion of subjects achieving Juvenile Idiopathic Arthritis and the American College of Rheumatology 30 (JIA-ACR 30) response at Week 16 for subjects with confirmed JPsA prior to baseline | Week 16 | Part B JIA-ACR 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 | Week 16 | Part B |
| Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16 | Week 16 | Part B |
| Observed average concentration at steady state for deucravacitinib at Week 16 | Week 16 | Part B |
| Maximum observed plasma concentration at steady state for deucravacitinib at Week 16 | Week 16 | Part B |
| Trough observed plasma concentration for deucravacitinib at Week 16 | Week 16 | Part B |
| Proportion of participants with 75% improvement in PASI (PASI 75) over time | 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 | Up to 316 weeks | LTE Period |
Countries
Argentina, Australia, Brazil, Canada, France, Germany, Japan, Mexico, Poland, Romania, South Korea, Spain, United Kingdom
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed