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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

Multiple Dose Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of BMS-986322 in Participants with Moderate-to-Severe Psoriasis (IM032-041)

Attanasio Massimo

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

mg-jp-clinical_trial@bms.com

Attanasio Massimo

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

+81-120-093-507

MG-JP-RCO-JRCT@bms.com

Complete

July. 01, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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.

-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.

Both

Moderate-to-Severe Psoriasis

Double-Blind, Placebo-Controlled, Parallel Group:BMS-986322
4 group randomized(64mg, 32mg, 16mg, Placebo)

-Proportion of participants achieving 75% reduction in PASI score (PASI-75) [ Time Frame: At week 12 ]
-Number of participants with treatment-emergent adverse event (TEAEs) [ Time Frame: Up to 16 weeks ]
-Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 16 weeks ]
-Number of participants with TEAEs leading to treatment discontinuation [ Time Frame: Up to 16 weeks ]
-Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 16 weeks ]
-Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: Up to 16 weeks ]
-Number of participants with vital sign abnormalities [ Time Frame: Up to 16 weeks ]
-Number of participants with physical examination abnormalities [ Time Frame: Up to 16 weeks ]

-Proportion of participants achieving sPGA score of 0 or 1 [ Time Frame: At week 12 ]
-Proportion of participants achieving 50% reduction in PASI score (PASI-50) [ Time Frame: At week 12 ]
-Proportion of participants achieving 90% reduction in PASI score (PASI-90) [ Time Frame: At week 12 ]
-Proportion of participants achieving 100% reduction in PASI score (PASI-100) [ Time Frame: At week 12 ]
-Proportion of participants achieving PASI-50 [ Time Frame: Up to week 12 ]
-Proportion of participants achieving PASI-75 [ Time Frame: Up to week 12 ]
-Proportion of participants achieving PASI-90 [ Time Frame: Up to week 12 ]
-Proportion of participants achieving PASI-100 [ Time Frame: Up to week 12 ]
-Change from baseline in PASI score [ Time Frame: Up to week 12 ]
-BMS-986322 trough concentrations [ Time Frame: Up to week 12 ]
-Maximum observed plasma concentration (Cmax) of BMS-986322 [ Time Frame: At day 15 ]
-Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)] of BMS-986322 [ Time Frame: At day 15 ]
-Time of maximum observed plasma concentration (Tmax) of BMS-986322 [ Time Frame: At day 15 ]

+81-3-3972-8111

May. 23, 2023

No

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