Moderate to Severe Psoriasis MedDRA version: 19.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Code: BMS-986165
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: BMS-986165
Current Sponsor code: BMS-986165
Other descriptive name: BMS986165
Concentration unit: mg milligram(s)
Conce
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female, ages 18 to 70 years - Diagnosis of plaque psoriasis for less or equal to 6 months - Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test, must not be pregnant, lactating, breastfeeding or planning pregnancy. - Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the study drug plus 90 days. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 439 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 77
Exclusion criteria
Exclusion criteria: - Diagnosis of non-plaque psoriasis - History or evidence of active infection and/or febrile illness - Any significant acute or chronic medical illness - Blood transfusion within 4 weeks of study drug administration - Inability to tolerate oral medication - Positive hepatitis-B (HBV) surface antigen - Positive hepatitis-C (HCV) antibody - Any history or risk for tuberculosis (TB) - Any major illness/condition or evidence of an unstable clinical condition - Chest X-ray findings suspicious of infection at screening - Has received ustekinumab, secukinumab or ixikizumab within 6 months of first administration of study medication - Has received anti-TNF inhibitor(s) within 2 months of first administration of study medication - Has received Rituximab within 6 months of first administration of study medication - Topical medications/treatments for psoriasis within 2 weeks of the first administration of any study medication - any systemic medications/treatments for psoriasis within 4 weeks of the first administration of any study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare the proportion of subjects with moderate to severe psoriasis experiencing a 75% improvement as measured by reduction in psoriasis area and severity index (PASI-75) score after 12 weeks of treatment between doses of BMS-986165 and placebo. - To assess the safety and tolerability of multiple oral doses of BMS-986165 in subjects with moderate to severe psoriasis;Secondary Objective: To assess that the proportion of subjects (sbj) experiencing a 75% reduction in psoriasis area and severity index (PASI) score in the most efficacious treatment group/To compare the proportions of subjects experiencing a 75% reduction in PASI score between treatment groups/To assess a positive trend btw treatment groups of BMS-986165 and proportion of sbj experiencing a 75% reduction in PASI score aftr 12 wks of treatment/To assess clinical efficacy of BMS-986165 as measured by improvement in skin disease area and severity indices PASI50/75/90/100 over time in sbj with moderate to severe psoriasis/To assess a significantly higher proportion of sbj achieving a static physician’s global assessment (sPGA) score of 0=cleared or 1=minimal after 12 wks of treatment with BMS-986165 than after 12 wks of treatment with placebo/To assess improvement by BMS-986165 in quality of life assessments (DLQI)/To assess the trough concentrations of BMS-986165 in sbj with moderate to severe psoriasis;Primary end point(s): 1/ Proportion of subjects reaching a 75% reduction in psoriasis activity and severity index (PASI-75) 2/ Safety and tolerability;Timepoint(s) of evaluation of this end point: 1/ Day 1 to Day 85 2/ Day 1 to 115 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/ The proportion of subjects reaching a 50% (PASI-50), 75% (PASI-75), 90% (PASI-90) and 100% (PASI-100) reduction in psoriasis activity and severity index 2/ The proportion of subjects reaching "0" and "1" on the static Physician Global Assessment score (sPGA) 3/ Dermatology Life Quality Index score 4/ Pharmacokinetics;Timepoint(s) of evaluation of this end point: 1/ to 4/ : Day 1 to Day 85 | — |
Countries
Australia, Canada, Germany, Japan, Latvia, Mexico, Poland, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed