A Phase 3 interventional study of Deucravacitinib and Placebo matching deucravacitinib in Plaque Psoriasis, sponsored by Bristol-Myers Squibb. Recruiting at 65 sites in 13 countries. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
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.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's planned enrollment of 153 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Drug: Deucravacitinib
Drug: Deucravacitinib
Other: Placebo matching deucravacitinib
Specified dose on specified days
Specified dose on specified days
Observed average concentration at steady state for deucravacitinib at Week 2
Part A
Time frame: Week 2
Maximum observed plasma concentration at steady state for deucravacitinib at Week 2
Part A
Time frame: Week 2
Trough observed plasma concentration for deucravacitinib at Week 2
Part A
Time frame: Week 2
Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16
Part B
Time frame: 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
Time frame: Week 16
Incidence of Adverse Events (AEs)
Long-term extension (LTE) Period
Time frame: Up to 316 weeks
Incidence of serious adverse events (SAEs)
LTE Period
Time frame: Up to 316 weeks
Monitoring of growth: Body weight
LTE Period
Time frame: Up to 316 weeks
Monitoring of growth: Height
LTE Period
Time frame: Up to 316 weeks
Monitoring of growth: Tanner staging (sexual maturation)
LTE Period
Time frame: Up to 316 weeks
Incidence of Adverse Events (AEs)
Part A and Part B
Time frame: Up to Week 52
Incidence of serious adverse events (SAEs)
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in lymphocyte subsets and function
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in cytokine levels
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in physical examination findings
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in vital signs: Body temperature
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in vital signs: Respiratory rate
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure
Part A and Part B
Time frame: Up to Week 52
Incidence of clinically significant changes in vital signs: Heart rate
Part A and Part B
Time frame: Up to Week 52
Monitoring of growth: Body weight
Part A and Part B
Time frame: Up to Week 52
Monitoring of growth: Height
Part A and Part B
Time frame: Up to Week 52
Monitoring of growth: Tanner staging (sexual maturation)
Part A and Part B
Time frame: Up to Week 52
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
Time frame: Week 16
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
Time frame: Week 16
Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo
Part B
Time frame: Week 16
Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo
Part B
Time frame: Week 16
Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo
Part B
Time frame: Week 16
Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo
Part B
Time frame: Week 16
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
Time frame: Week 16
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
Time frame: Week 16
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
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
Time frame: Week 16
Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo
Part B
Time frame: Week 16
Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16
Part B
Time frame: Week 16
Observed average concentration at steady state for deucravacitinib at Week 16
Part B
Time frame: Week 16
Maximum observed plasma concentration at steady state for deucravacitinib at Week 16
Part B
Time frame: Week 16
Trough observed plasma concentration for deucravacitinib at Week 16
Part B
Time frame: Week 16
Proportion of participants with 75% improvement in PASI (PASI 75) over time
LTE Period
Time frame: Up to 316 weeks
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
Time frame: Up to 316 weeks
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Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Mar 2021 (actual). Primary completion is estimated for Jan 2029, 93 months after the start.
Of 217 industry-sponsored phase 3 interventional studies under Psoriasis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 93 months is above that.
Counting every sponsor, half of 227 studies reached it within 15 months; a quarter within 10 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Deucravacitinib