A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.

Official Title
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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: BMS-986322
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of plaque psoriasis (PsO) for ≥ 6 months Body mass index 18 to 40 kg/m^2 and total body weight > 50 kg (110 lbs) Deemed by Investigator to be eligible for phototherapy or systemic therapy Psoriatic plaques must cover ≥ 10% of body surface area at baseline Psoriasis Area and Severity Index (PASI) score ≥ 12 and static Physician Global Assessment (sPGA) ≥ 3 at baseline Exclusion Criteria: Diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic) Diagnosis of uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with PsO for which a participant requires current systemic immunosuppressant medical treatment Any significant acute or chronic medical illness Other protocol-defined inclusion/exclusion criteria apply

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986322 Dose 1<br> | Drug: BMS-986322<br>* Specified dose on specified days<br>|
| Experimental: BMS-986322 Dose 2<br> | Drug: BMS-986322<br>* Specified dose on specified days<br>|
| Experimental: BMS-986322 Dose 3<br> | Drug: BMS-986322<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving 75% reduction in PASI score (PASI-75) |  | At week 12 | 
| Number of participants with treatment-emergent adverse event (TEAEs) |  | Up to 16 weeks | 
| Number of participants with serious adverse events (SAEs) |  | Up to 16 weeks | 
| Number of participants with TEAEs leading to treatment discontinuation |  | Up to 16 weeks | 
| Number of participants with clinical laboratory abnormalities |  | Up to 16 weeks | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 16 weeks | 
| Number of participants with vital sign abnormalities |  | Up to 16 weeks | 
| Number of participants with physical examination abnormalities |  | Up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving sPGA score of 0 or 1 |  | At week 12 | 
| Proportion of participants achieving 50% reduction in PASI score (PASI-50) |  | At week 12 | 
| Proportion of participants achieving 90% reduction in PASI score (PASI-90) |  | At week 12 | 
| Proportion of participants achieving 100% reduction in PASI score (PASI-100) |  | At week 12 | 
| Proportion of participants achieving PASI-50 |  | Up to week 12 | 
| Proportion of participants achieving PASI-75 |  | Up to week 12 | 
| Proportion of participants achieving PASI-90 |  | Up to week 12 | 
| Proportion of participants achieving PASI-100 |  | Up to week 12 | 
| Change from baseline in PASI score |  | Up to week 12 | 
| BMS-986322 trough concentrations |  | Up to week 12 | 
| Maximum observed plasma concentration (Cmax) of BMS-986322 |  | At day 15 | 
| Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)] of BMS-986322 |  | At day 15 | 
| Time of maximum observed plasma concentration (Tmax) of BMS-986322 |  | At day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate-to-Severe Psoriasis, BMS-986322, TYK2 inhibitor