A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis
- Registration Number
- NCT05730725
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-986322 Dose 1 BMS-986322 - Placebo Placebo - BMS-986322 Dose 2 BMS-986322 - BMS-986322 Dose 3 BMS-986322 -
- Primary Outcome Measures
Name Time Method Number of participants with physical examination abnormalities Up to 16 weeks Proportion of participants achieving 75% reduction in PASI score (PASI-75) At week 12 Number of participants with electrocardiogram (ECG) abnormalities Up to 16 weeks Number of participants with clinical laboratory abnormalities Up to 16 weeks Number of participants with vital sign abnormalities Up to 16 weeks 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
- Secondary Outcome Measures
Name Time Method Proportion of participants achieving 90% reduction in PASI score (PASI-90) At week 12 Proportion of participants achieving PASI-90 Up to week 12 Proportion of participants achieving PASI-100 Up to week 12 Proportion of participants achieving PASI-50 Up to week 12 Proportion of participants achieving PASI-75 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 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 100% reduction in PASI score (PASI-100) At week 12
Trial Locations
- Locations (35)
Local Institution - 0008
🇺🇸Cleveland, Ohio, United States
Local Institution - 0001
🇺🇸Los Angeles, California, United States
Local Institution - 0016
🇺🇸Los Angeles, California, United States
Local Institution - 0059
🇺🇸Dallas, Texas, United States
Local Institution - 0003
🇺🇸Santa Ana, California, United States
Local Institution - 0012
🇺🇸Encino, California, United States
Local Institution - 0006
🇺🇸Birmingham, Alabama, United States
Local Institution - 0005
🇺🇸Fountain Valley, California, United States
Local Institution - 0002
🇺🇸Fremont, California, United States
Local Institution - 0013
🇺🇸Coral Gables, Florida, United States
Local Institution - 0056
🇺🇸Skokie, Illinois, United States
Local Institution - 0057
🇺🇸Leawood, Kansas, United States
Local Institution - 0004
🇺🇸Beverly, Massachusetts, United States
Local Institution - 0007
🇺🇸Portsmouth, New Hampshire, United States
Local Institution - 0044
🇺🇸Clarksville, Indiana, United States
Local Institution - 0060
🇺🇸Lee's Summit, Missouri, United States
Local Institution - 0055
🇺🇸Durham, North Carolina, United States
Local Institution - 0058
🇺🇸Rapid City, South Dakota, United States
Local Institution - 0011
🇺🇸Webster, Texas, United States
Local Institution - 0024
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0019
🇦🇺Carlton, Victoria, Australia
Local Institution - 0045
🇦🇺Pascoe Vale South, Victoria, Australia
Local Institution - 0062
🇨🇦St. John's, Newfoundland and Labrador, Canada
Local Institution - 0034
🇨🇦Barrie, Ontario, Canada
Local Institution - 0020
🇨🇦Hamilton, Ontario, Canada
Local Institution - 0030
🇨🇦Toronto, Ontario, Canada
Local Institution - 0049
🇯🇵Sapporo-Shi, Hokkaido, Japan
Local Institution - 0023
🇯🇵Itabashi, Tokyo, Japan
Local Institution - 0051
🇯🇵Fukuoka-shi, Japan
Local Institution - 0042
🇯🇵Itabashi-Ku, Japan
Local Institution - 0026
🇯🇵Nagoya-Shi, Japan
Local Institution - 0046
🇬🇧Leytonstone, United Kingdom
Local Institution - 0027
🇯🇵Tsu City, Japan
Local Institution - 0050
🇬🇧Hinckley, LEC, United Kingdom
Local Institution - 0041
🇨🇦London, Ontario, Canada