Moderate to Severe Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and females between 12 to less than 18 years of age - diagnosed with stable (defined as no significant flares of disease activity or morphologic changes for 6 months) moderate to severe plaque psoriasis. Moderate to severe psoriasis defined by: (at screening visit and Day 1) Psoriasis Area and Severity Index (PASI) = 12, // static Physician’s Global Assessment (sPGA) = 3, // Body Surface Area (BSA) = 10% involvement - candidates for phototherapy or systemic therapy Are the trial subjects under 18? yes Number of subjects for this age range: 168 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Subject has non-plaque forms of psoriasis (e.g. erythrodermic, guttate, inverse or pustular) 2. Subjects weighing < 30 Kg at screening 3. Subject has any of the following TB criteria: a) History of active TB prior to screening visit, regardless of completion of adequate treatment b) Signs or symptoms of active TB during screening as judged by the investigator c) A chest x-ray showing evidence of current active or old active pulmonary TB d) Latent TB infection (LTBI) defined as positive IGRA (QuantiFERON-TB Gold) at screening 4. Received live vaccine within 60 days or plan to receive a live vaccine during the study or plan to receive live vaccine within 60 days of last dose of study medication 5. Currently being treated with biologic agents 6. History of ongoing, chronic or recurrent infectious disease, and opportunistic infection regardless of successfully treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: Pharmacokinetics: to evaluate the PK of BMS-986165 in subjects aged 12 to < 18 years with moderate to severe plaque psoriasis Part B: Efficacy: to evaluate the efficacy of the standard dose of BMS-986165 vs placebo in subjects aged 12 to < 18 years with moderate to severe plaque psoriasis;Secondary Objective: Part A: Safety: to evaluate the safety/tolerability of BMS-986165 in subjects aged 12 to < 18 years with moderate to severe plaque psoriasis Part B: Efficacy: to assess the efficacy in additional endpoints of BMS-986165 vs placebo in subjects aged 12 to < 18 years with moderate to severe plaque psoriasis;Primary end point(s): PART A: 1. Steady-state Cmax, Ctrough, and Css-avg for BMS-986165 PART B: 1. Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) 2. Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline ;Timepoint(s) of evaluation of this end point: Part A 1. Week 2 Part B 1. Week 16 2. Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part A: 1. AEs, SAEs, laboratory parameters, lymphocyte subsets and function, cytokine levels, physical examination and vital signs throughout the study 2. Monitoring of growth including body weight and height, and sexual maturation Part B: 1. Proportion of subjects with at least 75% improvement in PASI (PASI 75) for the comparison of the half-standard dose of BMS-986165 vs placebo 2. Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline for the comparison of the half-standard dose of BMS-986165 vs placebo 3. Proportion of subjects with at least 90% improvement in PASI (PASI 90) 4. Change from baseline in PASI 5. Change from baseline in BSA involvement 6. Change from baseline in CDLQI score 7. Change from baseline in subject reported visual analog scale (VAS) for subject’s assessment of joint pain (only for subjects with confirmed JPsA prior to baseline) 8. Change from baseline in VAS for subject’s Global Assessment of Joint Disease (only for subjects with confirmed JPsA prior to baseline) 9. Proportion of subjects achieving American College ofRheumatology Pediatric 30 (ACR Pedi 30) response for subjects with confirmed JPsA prior to baseline. 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% 10. Proportion of subjects using topical corticosteroid 11. AEs, SAEs, laboratory parameters, lymphocyte subsets and function, cytokine levels, physical examination and vital signs 12. Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis 13. Monitoring of growth including body weight and height, and sexual maturation 14. Steady-state Cmax, Ctrough, and Css-avg for BMS-986165 ;Timepoint(s) of evaluation of this end point: Part A: 1. and 2. Throughout the study Part B: | — |
Countries
Australia, Canada, Czechia, France, Poland, Spain, United Kingdom, United States
Contacts
Public ContactGSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed