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A Study to Evaluate the Drug Levels, Efficacy and Safety of BMS-986165 in Adolescent Participants With Moderate to Severe Plaque Psoriasis

  • Clinicaltrials.gov identifier

    NCT04772079

  • Recruitment Status

    Recruiting

  • First Posted

    February 26, 2021

  • Last update posted

    November 23, 2021

Study Description

Brief summary:

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of BMS-986165 in adolescent participants aged 12 to <18 years with moderate to severe plaque psoriasis. This study has two parts. Part A will evaluate the drug levels of BMS-986165 in adolescent participants ages 12 to <18 years 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 adolescents participants with moderate to severe plaque psoriasis.

  • Condition or Disease:Plaque Psoriasis
  • Intervention/Treatment: Drug: BMS-986165
    Other: Placebo matching BMS-986165
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 84 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 BMS-986165 in Adolescent Subjects With Moderate to Severe Plaque Psoriasis
  • Actual Study Start Date: March 2021
  • Estimated Primary Completion Date: April 2024
  • Estimated Study Completion Date: April 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Active treatment (BMS-986165) half-standard dose
Drug: BMS-986165
Specified dose on specified days
Experimental: Active treatment (BMS-986165) standard dose
Drug: BMS-986165
Specified dose on specified days
Placebo Comparator: Placebo
Other: Placebo matching BMS-986165
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Steady-state maximum observed concentration (Cmax) for BMS-986165 at Week 2 [ Time Frame: Week 2 ]
    Part A
  • 2. Steady-state trough observed plasma concentration (Ctrough) for BMS-986165 at Week 2 [ Time Frame: Week 2 ]
    Part A
  • 3. Average concentration steady state (Css-avg) for BMS-986165 at Week 2 [ Time Frame: Week 2 ]
    Part A
  • 4. 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
  • 5. 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
  • Secondary Outcome Measures: 1. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 2. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 3. Incidence of Adverse Events (AEs) [ Time Frame: Up to 424 days ]
    Part A and Part B
  • 4. Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 5. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 6. Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests [ Time Frame: Up to 410 days ]
    Part A and Part B
  • 7. Incidence of clinically significant changes in clinical laboratory results: Infectious serologies tests [ Time Frame: Up to 42 days ]
    Part A and Part B
  • 8. Incidence of clinically significant changes in clinical laboratory results: Tuberculosis (TB) tests [ Time Frame: Up to 42 days ]
    Part A and Part B
  • 9. Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests [ Time Frame: Up to 368 days ]
    Part A and Part B
  • 10. Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests [ Time Frame: Up to 368 days ]
    Part A and Part B
  • 11. Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests [ Time Frame: Up to 368 days ]
    Part A and Part B
  • 12. 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
  • 13. Incidence of clinically significant changes in lymphocyte subsets and function [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 14. Incidence of clinically significant changes in cytokine levels [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 15. Incidence of clinically significant changes in physical examination findings [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 16. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 17. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 18. Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 19. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 20. Monitoring of growth: Body weight [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 21. Monitoring of growth: Height [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 22. Monitoring of growth: Body mass index (BMI) [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 23. Monitoring of growth: Tanner staging (sexual maturation) [ Time Frame: Up to 466 days ]
    Part A and Part B
  • 24. Proportion of subjects with at least 75% improvement in PASI (PASI 75) at Week 16 for the comparison of the half-standard dose of BMS-986165 vs placebo [ Time Frame: Week 16 ]
    Part B
  • 25. 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 BMS-986165 vs placebo [ Time Frame: Week 16 ]
    Part B
  • 26. Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of BMS-986165 vs placebo [ Time Frame: Week 16 ]
    Part B
  • 27. Change from baseline in PASI at Week 16 for comparison of BMS-986165 vs placebo [ Time Frame: Week 16 ]
    Part B
  • 28. Change from baseline in BSA involvement at Week 16 for comparison of BMS-986165 vs placebo [ Time Frame: Week 16 ]
    Part B
  • 29. Change from baseline in CDLQI score at Week 16 for comparison of BMS-986165 vs placebo [ Time Frame: Week 16 ]
    Part B
  • 30. 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 BMS-986165 vs placebo [ Time Frame: Week 16 ]
    Part B
  • 31. 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 BMS-986165 vs placebo [ Time Frame: Week 16 ]
    Part B
  • 32. 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 BMS-986165 vs placebo
  • 33. Proportion of subjects using topical corticosteroid at Week 16 for comparison of BMS-986165 vs placebo [ Time Frame: Week 16 ]
    Part B
  • 34. Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16 [ Time Frame: Week 16 ]
    Part B
  • 35. Steady-state maximum observed concentration (Cmax) for BMS-986165 at Week 16 [ Time Frame: Week 16 ]
    Part B
  • 36. Steady-state trough observed plasma concentration (Ctrough) for BMS-986165 at Week 16 [ Time Frame: Week 16 ]
    Part B
  • 37. Average concentration steady state (Css-avg) for BMS-986165 at Week 16 [ Time Frame: Week 16 ]
    Part B

Eligibility Criteria

  • Ages Eligible for Study: 12 to 18 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Males and females aged 12 to <18 years Plaque psoriasis for at least 6 months Moderate to severe disease Candidate for phototherapy or systemic therapy Exclusion Criteria: Weighing ≤ 30.0 kg at screening Other forms of psoriasis History of recent infection Prior exposure to BMS-986165 or active comparator Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

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

Locations

Australia, New South Wales
The Skin Hospital
Sydney

Australia, New South Wales
Local Institution
Westmead

Australia, Queensland
Veracity Clinical Research
Brisbane

Australia, Victoria
Sinclair Dermatology
East Melbourne

Canada, Alberta
Local Institution
Calgary

Canada, Ontario
Local Institution
Markham

Canada, Quebec
Local Institution
Montreal

France
Local Institution
Nice

France
Hopital Robert Debre
Paris

Poland
Local Institution
Krakow

Poland
Local Institution
Lodz

Poland
Local Institution
Warszawa

Poland
Local Institution
Wroclaw

Spain
Local Institution
Alicante

Spain
Local Institution
Barakaldo

Spain
Local Institution
Esplugues de Llobregat

Spain
Local Institution
Las Palmas De GC

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

United Kingdom
Local Institution
Connor Downs

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04772079 History of Changes
  • Other Study ID Numbers: IM011-126, 2019-004879-39
  • First Posted: February 26, 2021 Key Record Dates
  • Last Update Posted: November 23, 2021
  • Last Verified: November 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Adolescent Psoriasis
    BMS-986165
    Clinical trial
    Deucravacitinib
    Pediatric
    Pediatric Psoriasis
    Plaque Psoriasis
    Psoriasis
  • Additional relevant MeSH terms: Psoriasis
    Skin Diseases, Papulosquamous
    Skin Diseases