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

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; 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: 120 estimated 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

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120 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