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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04772079
• Collaborator: (none)
• Enrollment: 84
• Locations: 21
• Arms: 3
• Anticipated Duration (Months): 125.6
• Patients Per Site: 4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib 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.The long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in adolescent 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 Design

• Study Type: Interventional
• Anticipated 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 Deucravacitinib (BMS-986165) in Adolescent Subjects With Moderate to Severe Plaque Psoriasis
• Actual Study Start Date: Mar 23, 2021
• Anticipated Primary Completion Date: Apr 15, 2024
• Anticipated Study Completion Date: Sep 9, 2031

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Steady-state maximum observed concentration (Cmax) for deucravacitinib at Week 2 [Week 2]

   Part A

2. Steady-state trough observed plasma concentration (Ctrough) for deucravacitinib at Week 2 [Week 2]

   Part A

3. Average concentration steady state (Css-avg) for deucravacitinib at Week 2 [Week 2]

   Part A

4. Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16 [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 [Week 16]

   Part B

6. Incidence of Adverse Events (AEs) [Up to 316 weeks]

   Long-term extension (LTE) Period

7. Incidence of serious adverse events (SAEs) [Up to 316 weeks]

   LTE Period

8. Monitoring of growth: Body weight [Up to 316 weeks]

   LTE Period

9. Monitoring of growth: Height [Up to 316 weeks]

   LTE Period

10. Monitoring of growth: Tanner staging (sexual maturation) [Up to 316 weeks]

    LTE Period

Secondary Outcome Measures

1. Incidence of Adverse Events (AEs) [Up to 424 days]

   Part A and Part B

2. Incidence of serious adverse events (SAEs) [Up to 466 days]

   Part A and Part B

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

   Part A and Part B

4. Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [Up to 466 days]

   Part A and Part B

5. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to 466 days]

   Part A and Part B

6. Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests [Up to 410 days]

   Part A and Part B

7. Incidence of clinically significant changes in clinical laboratory results: Infectious serologies tests [Up to 42 days]

   Part A and Part B

8. Incidence of clinically significant changes in clinical laboratory results: Tuberculosis (TB) tests [Up to 42 days]

   Part A and Part B

9. Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests [Up to 368 days]

   Part A and Part B

10. Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests [Up to 368 days]

    Part A and Part B

11. Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests [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 [Up to 466 days]

    Part A and Part B

13. Incidence of clinically significant changes in lymphocyte subsets and function [Up to 466 days]

    Part A and Part B

14. Incidence of clinically significant changes in cytokine levels [Up to 466 days]

    Part A and Part B

15. Incidence of clinically significant changes in physical examination findings [Up to 466 days]

    Part A and Part B

16. Incidence of clinically significant changes in vital signs: Body temperature [Up to 466 days]

    Part A and Part B

17. Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 466 days]

    Part A and Part B

18. Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure [Up to 466 days]

    Part A and Part B

19. Incidence of clinically significant changes in vital signs: Heart rate [Up to 466 days]

    Part A and Part B

20. Monitoring of growth: Body weight [Up to 466 days]

    Part A and Part B

21. Monitoring of growth: Height [Up to 466 days]

    Part A and Part B

22. Monitoring of growth: Tanner staging (sexual maturation) [Up to 466 days]

    Part A and Part B

23. 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

24. 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

25. 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

26. Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo [Week 16]

    Part B

27. Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo [Week 16]

    Part B

28. Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo [Week 16]

    Part B

29. 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

30. 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

31. 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 [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

32. Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo [Week 16]

    Part B

33. Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16 [Week 16]

    Part B

34. Steady-state maximum observed concentration (Cmax) for deucravacitinib at Week 16 [Week 16]

    Part B

35. Steady-state trough observed plasma concentration (Ctrough) for deucravacitinib at Week 16 [Week 16]

    Part B

36. Average concentration steady state (Css-avg) for deucravacitinib at Week 16 [Week 16]

    Part B

37. Proportion of participants with 75% improvement in PASI (PASI 75) over time [Up to 316 weeks]

    LTE Period

38. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

• Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period

Exclusion Criteria:

• Weighing ≤ 30.0 kg at screening

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Skin Hospital	Sydney	New South Wales	Australia	2010
2	Local Institution	Westmead	New South Wales	Australia	2145
3	Local Institution - 0003	Woolloongabba	Queensland	Australia	4102
4	Sinclair Dermatology	East Melbourne	Victoria	Australia	3002
5	Local Institution	Calgary	Alberta	Canada	T2J 7E1
6	Local Institution - 0008	Markham	Ontario	Canada	L3P 1X2
7	Local Institution - 0009	Montréal	Quebec	Canada	H3T 1C5
8	Local Institution	Dijon		France	21000
9	Local Institution	Nice		France	6200
10	Hopital Robert Debre	Paris		France	75019
11	Local Institution	Krakow		Poland	30-510
12	Local Institution	Lodz		Poland	90-436
13	Local Institution	Warszawa		Poland	02-507
14	Local Institution - 0005	Wroclaw		Poland	51-620
15	Local Institution	Alicante		Spain	03010
16	Local Institution	Barakaldo		Spain	48903
17	Local Institution	Esplugues de Llobregat		Spain	08950
18	Local Institution	Las Palmas De GC		Spain	35019
19	Local Institution	Madrid		Spain	28041
20	Local Institution	Madrid		Spain	28046
21	Local Institution - 0019	Connor Downs		United Kingdom	TR27 5DT

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04772079
• Other Study ID Numbers: IM011-126; 2019-004879-39
• First Posted: Feb 26, 2021
• Last Update Posted: Jul 5, 2022
• Last Verified: Jul 1, 2022

• 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

Study Results

No Results Posted as of Jul 5, 2022