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

Browse trials for

• Psoriasis 1,895

Keywords

• Adolescent Psoriasis
• BMS-986165
• Clinical trial
• Deucravacitinib
• Children Psoriasis
• Pediatric Psoriasis
• Plaque Psoriasis
• Psoriasis

Study arms

• Experimental
  Active treatment deucravacitinib standard dose

  Drug: Deucravacitinib

• Experimental
  Active treatment deucravacitinib half-standard dose

  Drug: Deucravacitinib

• Placebo comparator
  Placebo

  Other: Placebo matching deucravacitinib

Interventions

• DrugDeucravacitinib

  Specified dose on specified days

• OtherPlacebo matching deucravacitinib

  Specified dose on specified days

Primary outcomes

1. Observed average concentration at steady state for deucravacitinib at Week 2

   Part A

   Time frame: Week 2

2. Maximum observed plasma concentration at steady state for deucravacitinib at Week 2

   Part A

   Time frame: Week 2

3. Trough observed plasma concentration for deucravacitinib at Week 2

   Part A

   Time frame: Week 2

4. 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

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

   Part B

   Time frame: Week 16

6. Incidence of Adverse Events (AEs)

   Long-term extension (LTE) Period

   Time frame: Up to 316 weeks

7. Incidence of serious adverse events (SAEs)

   LTE Period

   Time frame: Up to 316 weeks

8. Monitoring of growth: Body weight

   LTE Period

   Time frame: Up to 316 weeks

9. Monitoring of growth: Height

   LTE Period

   Time frame: Up to 316 weeks

10. Monitoring of growth: Tanner staging (sexual maturation)

    LTE Period

    Time frame: Up to 316 weeks

Secondary outcomes

1. Incidence of Adverse Events (AEs)

   Part A and Part B

   Time frame: Up to Week 52

2. Incidence of serious adverse events (SAEs)

   Part A and Part B

   Time frame: Up to Week 52

3. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

   Part A and Part B

   Time frame: Up to Week 52

4. Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests

   Part A and Part B

   Time frame: Up to Week 52

5. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

   Part A and Part B

   Time frame: Up to Week 52

6. Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests

   Part A and Part B

   Time frame: Up to Week 52

7. Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests

   Part A and Part B

   Time frame: Up to Week 52

8. Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests

   Part A and Part B

   Time frame: Up to Week 52

9. Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests

   Part A and Part B

   Time frame: Up to Week 52

10. 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

11. Incidence of clinically significant changes in lymphocyte subsets and function

    Part A and Part B

    Time frame: Up to Week 52

12. Incidence of clinically significant changes in cytokine levels

    Part A and Part B

    Time frame: Up to Week 52

13. Incidence of clinically significant changes in physical examination findings

    Part A and Part B

    Time frame: Up to Week 52

14. Incidence of clinically significant changes in vital signs: Body temperature

    Part A and Part B

    Time frame: Up to Week 52

15. Incidence of clinically significant changes in vital signs: Respiratory rate

    Part A and Part B

    Time frame: Up to Week 52

16. Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure

    Part A and Part B

    Time frame: Up to Week 52

17. Incidence of clinically significant changes in vital signs: Heart rate

    Part A and Part B

    Time frame: Up to Week 52

18. Monitoring of growth: Body weight

    Part A and Part B

    Time frame: Up to Week 52

19. Monitoring of growth: Height

    Part A and Part B

    Time frame: Up to Week 52

20. Monitoring of growth: Tanner staging (sexual maturation)

    Part A and Part B

    Time frame: Up to Week 52

21. 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

22. 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

23. 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

24. Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo

    Part B

    Time frame: Week 16

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

    Part B

    Time frame: Week 16

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

    Part B

    Time frame: Week 16

27. 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

28. 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

29. 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

30. Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo

    Part B

    Time frame: Week 16

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

    Part B

    Time frame: Week 16

32. Observed average concentration at steady state for deucravacitinib at Week 16

    Part B

    Time frame: Week 16

33. Maximum observed plasma concentration at steady state for deucravacitinib at Week 16

    Part B

    Time frame: Week 16

34. Trough observed plasma concentration for deucravacitinib at Week 16

    Part B

    Time frame: Week 16

35. Proportion of participants with 75% improvement in PASI (PASI 75) over time

    LTE Period

    Time frame: Up to 316 weeks

36. 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

Related links

• BMS Clinical Trial Information ↗
• BMS Clinical Trial Patient Recruiting ↗

Individual participant data

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, Sap, Csr