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

JRCT ID: jRCT2031230177

Registered date:25/06/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Moderate-to-Severe Psoriasis
• Date of first enrollment: 01/07/2023
• Target sample size: 12
• Countries of recruitment: Australia,Japan,Canada,Japan,Czechia,Japan,France,Japan,Poland,Japan,Spain,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

Primary Outcome

-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 ]

Secondary Outcome

-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 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 70age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Attanasio Massimo
• Secondary ID(s): NCT05730725