Clinical trial NCT05730725: A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Moderate-to-Severe Psoriasis
BMS-986322
TYK2 inhibitor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-02-16
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants achieving 75% reduction in PASI score (PASI-75)
timeFrame: At week 12
measure: Number of participants with treatment-emergent adverse event (TEAEs)
timeFrame: Up to 16 weeks
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 16 weeks
measure: Number of participants with TEAEs leading to treatment discontinuation
timeFrame: Up to 16 weeks
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 16 weeks
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 16 weeks
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 16 weeks
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Proportion of participants achieving sPGA score of 0 or 1
timeFrame: At week 12
measure: Proportion of participants achieving 50% reduction in PASI score (PASI-50)
timeFrame: At week 12
measure: Proportion of participants achieving 90% reduction in PASI score (PASI-90)
timeFrame: At week 12
measure: Proportion of participants achieving 100% reduction in PASI score (PASI-100)
timeFrame: At week 12
measure: Proportion of participants achieving PASI-50
timeFrame: Up to week 12
measure: Proportion of participants achieving PASI-75
timeFrame: Up to week 12
measure: Proportion of participants achieving PASI-90
timeFrame: Up to week 12
measure: Proportion of participants achieving PASI-100
timeFrame: Up to week 12
measure: Change from baseline in PASI score
timeFrame: Up to week 12
measure: BMS-986322 trough concentrations
timeFrame: Up to week 12
measure: Maximum observed plasma concentration (Cmax) of BMS-986322
timeFrame: At day 15
measure: Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)] of BMS-986322
timeFrame: At day 15
measure: Time of maximum observed plasma concentration (Tmax) of BMS-986322
timeFrame: At day 15
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0006
state: Alabama
city: Encino
country: United States
facility: Local Institution - 0012
state: California
city: Fountain Valley
country: United States
facility: Local Institution - 0005
state: California
city: Fremont
country: United States
facility: Local Institution - 0002
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0001
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0016
state: California
city: Santa Ana
country: United States
facility: Local Institution - 0003
state: California
city: Coral Gables
country: United States
facility: Local Institution - 0013
state: Florida
city: Skokie
country: United States
facility: Local Institution - 0056
state: Illinois
city: Clarksville
country: United States
facility: Local Institution - 0044
state: Indiana
city: Leawood
country: United States
facility: Local Institution - 0057
state: Kansas
city: Beverly
country: United States
facility: Local Institution - 0004
state: Massachusetts
city: Lee's Summit
country: United States
facility: Local Institution - 0060
state: Missouri
city: Portsmouth
country: United States
facility: Local Institution - 0007
state: New Hampshire
city: Durham
country: United States
facility: Local Institution - 0055
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution - 0008
state: Ohio
city: Rapid City
country: United States
facility: Local Institution - 0058
state: South Dakota
city: Dallas
country: United States
facility: Local Institution - 0059
state: Texas
city: Webster
country: United States
facility: Local Institution - 0011
state: Texas
city: Brisbane
country: Australia
facility: Local Institution - 0024
state: Queensland
city: Carlton
country: Australia
facility: Local Institution - 0019
state: Victoria
city: Pascoe Vale South
country: Australia
facility: Local Institution - 0045
state: Victoria
city: St. John's
country: Canada
facility: Local Institution - 0062
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: Local Institution - 0034
state: Ontario
city: Hamilton
country: Canada
facility: Local Institution - 0020
state: Ontario
city: London
country: Canada
facility: Local Institution - 0041
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0030
state: Ontario
city: Sapporo-Shi
country: Japan
facility: Local Institution - 0049
state: Hokkaido
city: Itabashi
country: Japan
facility: Local Institution - 0023
state: Tokyo
city: Fukuoka-shi
country: Japan
facility: Local Institution - 0051
city: Itabashi-Ku
country: Japan
facility: Local Institution - 0042
city: Nagoya-Shi
country: Japan
facility: Local Institution - 0026
city: Tsu City
country: Japan
facility: Local Institution - 0027
city: Hinckley
country: United Kingdom
facility: Local Institution - 0050
state: LEC
city: Leytonstone
country: United Kingdom
facility: Local Institution - 0046
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: