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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2

Conditions

Psoriasis

Treatments

Other: Placebo
Drug: BMS-986322

Study type

Interventional

Funder types

Industry

Identifiers

NCT05730725
U1111-1282-3606 (Registry Identifier)
2023-504848-34 (EudraCT Number)
IM032-041

Details and patient eligibility

About

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

Enrollment

109 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

109 participants in 4 patient groups, including a placebo group

BMS-986322 Dose 1
Experimental group
Treatment:
Drug: BMS-986322
BMS-986322 Dose 2
Experimental group
Treatment:
Drug: BMS-986322
BMS-986322 Dose 3
Experimental group
Treatment:
Drug: BMS-986322
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

40

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Central trial contact

First line of the email MUST contain NCT # and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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