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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05730725
• Other study ID #: IM032-041
• Secondary ID: 2023-504848-34U1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 3, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BMS-986322
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution - 0024	Brisbane	Queensland
Australia	Local Institution - 0019	Carlton	Victoria
Australia	Local Institution - 0045	Pascoe Vale South	Victoria
Canada	Local Institution - 0034	Barrie	Ontario
Canada	Local Institution - 0020	Hamilton	Ontario
Canada	Local Institution - 0041	London	Ontario
Canada	Local Institution - 0062	St. John's	Newfoundland and Labrador
Canada	Local Institution - 0030	Toronto	Ontario
Japan	Local Institution - 0051	Fukuoka-shi
Japan	Local Institution - 0023	Itabashi	Tokyo
Japan	Local Institution - 0042	Itabashi-Ku
Japan	Local Institution - 0026	Nagoya-Shi
Japan	Local Institution - 0049	Sapporo-Shi	Hokkaido
Japan	Local Institution - 0027	Tsu City
United Kingdom	Local Institution - 0050	Hinckley	LEC
United Kingdom	Local Institution - 0046	Leytonstone
United States	Local Institution - 0004	Beverly	Massachusetts
United States	Local Institution - 0006	Birmingham	Alabama
United States	Local Institution - 0044	Clarksville	Indiana
United States	Local Institution - 0008	Cleveland	Ohio
United States	Local Institution - 0013	Coral Gables	Florida
United States	Local Institution - 0059	Dallas	Texas
United States	Local Institution - 0055	Durham	North Carolina
United States	Local Institution - 0012	Encino	California
United States	Local Institution - 0005	Fountain Valley	California
United States	Local Institution - 0002	Fremont	California
United States	Local Institution - 0057	Leawood	Kansas
United States	Local Institution - 0060	Lee's Summit	Missouri
United States	Local Institution - 0001	Los Angeles	California
United States	Local Institution - 0016	Los Angeles	California
United States	Local Institution - 0007	Portsmouth	New Hampshire
United States	Local Institution - 0058	Rapid City	South Dakota
United States	Local Institution - 0003	Santa Ana	California
United States	Local Institution - 0056	Skokie	Illinois
United States	Local Institution - 0011	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Japan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants achieving 75% reduction in PASI score (PASI-75)		At week 12
Primary	Number of participants with treatment-emergent adverse event (TEAEs)		Up to 16 weeks
Primary	Number of participants with serious adverse events (SAEs)		Up to 16 weeks
Primary	Number of participants with TEAEs leading to treatment discontinuation		Up to 16 weeks
Primary	Number of participants with clinical laboratory abnormalities		Up to 16 weeks
Primary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 16 weeks
Primary	Number of participants with vital sign abnormalities		Up to 16 weeks
Primary	Number of participants with physical examination abnormalities		Up to 16 weeks
Secondary	Proportion of participants achieving sPGA score of 0 or 1		At week 12
Secondary	Proportion of participants achieving 50% reduction in PASI score (PASI-50)		At week 12
Secondary	Proportion of participants achieving 90% reduction in PASI score (PASI-90)		At week 12
Secondary	Proportion of participants achieving 100% reduction in PASI score (PASI-100)		At week 12
Secondary	Proportion of participants achieving PASI-50		Up to week 12
Secondary	Proportion of participants achieving PASI-75		Up to week 12
Secondary	Proportion of participants achieving PASI-90		Up to week 12
Secondary	Proportion of participants achieving PASI-100		Up to week 12
Secondary	Change from baseline in PASI score		Up to week 12
Secondary	BMS-986322 trough concentrations		Up to week 12
Secondary	Maximum observed plasma concentration (Cmax) of BMS-986322		At day 15
Secondary	Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)] of BMS-986322		At day 15
Secondary	Time of maximum observed plasma concentration (Tmax) of BMS-986322		At day 15

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting