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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05730725
Collaborator
(none)
120
Enrollment
4
Arms
15
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 28, 2023
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986322 Dose 1

Drug: BMS-986322
Specified dose on specified days
Experimental: BMS-986322 Dose 2

Drug: BMS-986322
Specified dose on specified days
Experimental: BMS-986322 Dose 3

Drug: BMS-986322
Specified dose on specified days
Placebo Comparator: Placebo

Other: Placebo
Specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants achieving 75% reduction in PASI score (PASI-75) [At week 12]

  2. Number of participants with treatment-emergent adverse event (TEAEs) [Up to 16 weeks]

  3. Number of participants with serious adverse events (SAEs) [Up to 16 weeks]

  4. Number of participants with TEAEs leading to treatment discontinuation [Up to 16 weeks]

  5. Number of participants with clinical laboratory abnormalities [Up to 16 weeks]

  6. Number of participants with electrocardiogram (ECG) abnormalities [Up to 16 weeks]

  7. Number of participants with vital sign abnormalities [Up to 16 weeks]

  8. Number of participants with physical examination abnormalities [Up to 16 weeks]

Secondary Outcome Measures

  1. Proportion of participants achieving sPGA score of 0 or 1 [At week 12]

  2. Proportion of participants achieving 50% reduction in PASI score (PASI-50) [At week 12]

  3. Proportion of participants achieving 90% reduction in PASI score (PASI-90) [At week 12]

  4. Proportion of participants achieving 100% reduction in PASI score (PASI-100) [At week 12]

  5. Proportion of participants achieving PASI-50 [Up to week 12]

  6. Proportion of participants achieving PASI-75 [Up to week 12]

  7. Proportion of participants achieving PASI-90 [Up to week 12]

  8. Proportion of participants achieving PASI-100 [Up to week 12]

  9. Change from baseline in PASI score [Up to week 12]

  10. BMS-986322 trough concentrations [Up to week 12]

  11. Maximum observed plasma concentration (Cmax) of BMS-986322 [At day 15]

  12. Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)] of BMS-986322 [At day 15]

  13. Time of maximum observed plasma concentration (Tmax) of BMS-986322 [At day 15]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT05730725
Other Study ID Numbers:
  • IM032-041
  • 2022-501951-10
  • U1111-1282-3606
First Posted:
Feb 16, 2023
Last Update Posted:
Feb 16, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bristol-Myers Squibb
Moderate-to-Severe Psoriasis
BMS-986322
TYK2 inhibitor
Additional relevant MeSH terms:
Psoriasis

Study Results

No Results Posted as of Feb 16, 2023