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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05730725




Registration number
NCT05730725
Ethics application status
Date submitted
7/02/2023
Date registered
16/02/2023
Date last updated
19/09/2024

Titles & IDs
Public title
A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis
Scientific 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
Secondary ID [1] 0 0
2023-504848-34
Secondary ID [2] 0 0
IM032-041
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986322
Other interventions - Placebo

Experimental: BMS-986322 Dose 1 -

Experimental: BMS-986322 Dose 2 -

Experimental: BMS-986322 Dose 3 -

Placebo comparator: Placebo -


Treatment: Drugs: BMS-986322
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants achieving 75% reduction in PASI score (PASI-75)
Timepoint [1] 0 0
At week 12
Primary outcome [2] 0 0
Number of participants with treatment-emergent adverse event (TEAEs)
Timepoint [2] 0 0
Up to 16 weeks
Primary outcome [3] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [3] 0 0
Up to 16 weeks
Primary outcome [4] 0 0
Number of participants with TEAEs leading to treatment discontinuation
Timepoint [4] 0 0
Up to 16 weeks
Primary outcome [5] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [5] 0 0
Up to 16 weeks
Primary outcome [6] 0 0
Number of participants with electrocardiogram (ECG) abnormalities
Timepoint [6] 0 0
Up to 16 weeks
Primary outcome [7] 0 0
Number of participants with vital sign abnormalities
Timepoint [7] 0 0
Up to 16 weeks
Primary outcome [8] 0 0
Number of participants with physical examination abnormalities
Timepoint [8] 0 0
Up to 16 weeks
Secondary outcome [1] 0 0
Proportion of participants achieving sPGA score of 0 or 1
Timepoint [1] 0 0
At week 12
Secondary outcome [2] 0 0
Proportion of participants achieving 50% reduction in PASI score (PASI-50)
Timepoint [2] 0 0
At week 12
Secondary outcome [3] 0 0
Proportion of participants achieving 90% reduction in PASI score (PASI-90)
Timepoint [3] 0 0
At week 12
Secondary outcome [4] 0 0
Proportion of participants achieving 100% reduction in PASI score (PASI-100)
Timepoint [4] 0 0
At week 12
Secondary outcome [5] 0 0
Proportion of participants achieving PASI-50
Timepoint [5] 0 0
Up to week 12
Secondary outcome [6] 0 0
Proportion of participants achieving PASI-75
Timepoint [6] 0 0
Up to week 12
Secondary outcome [7] 0 0
Proportion of participants achieving PASI-90
Timepoint [7] 0 0
Up to week 12
Secondary outcome [8] 0 0
Proportion of participants achieving PASI-100
Timepoint [8] 0 0
Up to week 12
Secondary outcome [9] 0 0
Change from baseline in PASI score
Timepoint [9] 0 0
Up to week 12
Secondary outcome [10] 0 0
BMS-986322 trough concentrations
Timepoint [10] 0 0
Up to week 12
Secondary outcome [11] 0 0
Maximum observed plasma concentration (Cmax) of BMS-986322
Timepoint [11] 0 0
At day 15
Secondary outcome [12] 0 0
Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)] of BMS-986322
Timepoint [12] 0 0
At day 15
Secondary outcome [13] 0 0
Time of maximum observed plasma concentration (Tmax) of BMS-986322
Timepoint [13] 0 0
At day 15

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/08/2024
Sample size
Target
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - 0024 - Brisbane
Recruitment hospital [2] 0 0
Local Institution - 0019 - Carlton
Recruitment hospital [3] 0 0
Local Institution - 0045 - Pascoe Vale South
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
3044 - Pascoe Vale South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Hampshire
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
South Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Canada
State/province [14] 0 0
Newfoundland and Labrador
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Japan
State/province [16] 0 0
Hokkaido
Country [17] 0 0
Japan
State/province [17] 0 0
Tokyo
Country [18] 0 0
Japan
State/province [18] 0 0
Fukuoka-shi
Country [19] 0 0
Japan
State/province [19] 0 0
Itabashi-Ku
Country [20] 0 0
Japan
State/province [20] 0 0
Nagoya-Shi
Country [21] 0 0
Japan
State/province [21] 0 0
Tsu City
Country [22] 0 0
United Kingdom
State/province [22] 0 0
LEC
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Leytonstone

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.
Trial website
https://clinicaltrials.gov/study/NCT05730725
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05730725