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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

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ClinicalTrials.gov Identifier: NCT04772079
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Intervention/treatment Phase
Plaque Psoriasis Drug: BMS-986165 Other: Placebo matching BMS-986165 Phase 3

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Study Type : Interventional  (Clinical Trial)
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 23, 2021
Estimated Primary Completion Date : April 15, 2024
Estimated Study Completion Date : April 16, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Active treatment (BMS-986165) standard dose Drug: BMS-986165
Specified dose on specified days

Experimental: Active treatment (BMS-986165) half-standard dose Drug: BMS-986165
Specified dose on specified days

Placebo Comparator: Placebo Other: Placebo matching BMS-986165
Specified dose on specified days




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 Adverse Events (AEs) [ Time Frame: Up to 424 days ]
    Part A and Part B

  2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 466 days ]
    Part A and Part B

  3. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 466 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years 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


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
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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
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Australia, New South Wales
Local Institution Not yet recruiting
Sydney, New South Wales, Australia, 2010
Contact: Site 0020         
Local Institution Not yet recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 0002         
Australia, Queensland
Local Institution Recruiting
Brisbane, Queensland, Australia, 4102
Contact: Site 0003         
Australia, Victoria
Local Institution Not yet recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Site 0001         
Canada, Alberta
Local Institution Not yet recruiting
Calgary, Alberta, Canada, T1Y0B4
Contact: Site 0010         
Canada, Ontario
Local Institution Recruiting
Markham, Ontario, Canada, L3P 1X2
Contact: Site 0008         
Canada, Quebec
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Site 0009         
France
Hopital De L'Archet Chu De Nice Withdrawn
Nice, France, 06202
Local Institution Not yet recruiting
Paris, France, 75019
Contact: Site 0021         
Poland
Local Institution Not yet recruiting
Krakow, Poland, 30-510
Contact: Site 0011         
Local Institution Not yet recruiting
Lodz, Poland, 90-436
Contact: Site 0006         
Local Institution Not yet recruiting
Wroclaw, Poland, 51-620
Contact: Site 0005         
Spain
Local Institution Not yet recruiting
Alicante, Spain, 03010
Contact: Site 0017         
Local Institution Not yet recruiting
Barakaldo, Spain, 48903
Contact: Site 0026         
Local Institution Not yet recruiting
Esplugues de Llobregat, Spain, 08950
Contact: Site 0014         
Local Institution Not yet recruiting
Las Palmas De GC, Spain, 35019
Contact: Site 0016         
Local Institution Not yet recruiting
Madrid, Spain, 28041
Contact: Site 0027         
Local Institution Recruiting
Madrid, Spain, 28046
Contact: Site 0022         
United Kingdom
Local Institution Not yet recruiting
Connor Downs, United Kingdom, TR27 5DT
Contact: Site 0019         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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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 24, 2021
Last Verified: May 2021

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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:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
BMS-986165
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action