Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis

Study Overview
=================
Brief Summary
-----------------
A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986165 in Subjects With Moderate to Severe Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: BMS-986165
* Drug: Placebo for BMS-986165


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Male and female, ages 18 to 70 years Diagnosis of plaque psoriasis for 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. Exclusion Criteria: 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 ixekizumab within 6 months of first administration of study medication Has received anti-Tumor Necrosis Factor (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 Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986165 Dose 1<br>Specified dose of BMS-986165 on specified days. | Drug: BMS-986165<br> <br> |
| Experimental: BMS-986165 Dose 2<br>Specified dose of BMS-986165 on specified days. | Drug: BMS-986165<br> <br> |
| Experimental: BMS-986165 Dose 3<br>Specified dose of BMS-986165 on specified days. | Drug: BMS-986165<br> <br> |
| Experimental: BMS-986165 Dose 4<br>Specified dose of BMS-986165 on specified days. | Drug: BMS-986165<br> <br> |
| Experimental: BMS-986165 Dose 5<br>Specified dose of BMS-986165 on specified days. | Drug: BMS-986165<br> <br> |
| Placebo Comparator: Placebo<br>Specified dose of Placebo for BMS-986165 on specified days. | Drug: Placebo for BMS-986165<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12) | Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity. | Day 1 to Day 85 | 
| Number of Participants With Adverse Events | The safety and tolerability of BMS-986195 as assessed by the number of subjects with adverse events (AEs); number of subjects with serious adverse events (SAEs); number of subjects with adverse events leading to discontinuation | Day 1 to day 115 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100. | Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 90 and PASI 100 responses on Day 85. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders. PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders. PASI 100 response: patients who achieved ≥ 100% improvement (reduction) in PASI score compared to baseline were defined as PASI 100 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity. | Day 1 to Day 85 | 
| Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate). | Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) on Day 85. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling. | Day 1 to Day 85 | 
| Change From Baseline in DLQI Scores on Day 85 | The DLQI is a participant reported quality of life index which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 by a tick box: not at all, a little, a lot, or very much. The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment) | Day 1 to Day 85 | 
| Change From Baseline in BSA on Day 85 | Measurement of psoriasis body surface area (BSA) involvement is estimated using the handprint method with the size of a patient's handprint representing  1% of body surface area involved.The total BSA = 100% with breakdown by body region as follows: head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), trunk including axillae and groin = 30% (30 handprints), lower extremities including buttocks = 40% (40 handprints). A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Day 85 score; a positive change from Baseline therefore indicates improvement. | Day 1 to Day 85 | 
| Trough Observed Plasma Concentration of BMS-986165 (Ctrough) | Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration | Days 8, 15, 29, 57, 85 |