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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trialsand research/disclosurecommitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05730725