The purpose of this Phase 2a/b study is: 1. to evaluate the efficacy, safety and tolerability of DDY391 in participants with psoriatic arthritis (PsA). 2. to determine the dose-response relationship of DDY391 in participants with PsA to support dose selection for Phase 3.
This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy, safety, tolerability and dose-response relationship of DDY391 in participants with active moderate to severe PsA. The study is composed of two sequential parts: * Part A to evaluate efficacy, safety and tolerability of DDY391 compared with placebo. * Part B to determine the dose-response relationship of multiple doses of DDY391 compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
Rheumatology Associates of South Texas
San Antonio, Texas, United States
RECRUITINGPart A: Number of participants achieving American College of Rheumatology 50 (ACR50) response
To evaluate the efficacy of DDY391 versus placebo through achievement of ACR 50. ACR 50 is a validated tool for assessing RA disease activity.
Time frame: Week 12
Part A and B: Number of participants achieving American College of Rheumatology 50 (ACR50) response
To demonstrate the dose-response relationship of DDY391 compared to placebo in bDMARD-IR participants.
Time frame: Week 12
Part B: Number of participants achieving American College of Rheumatology 50 (ACR50) response
To demonstrate the dose-response relationship of DDY391 compared to placebo in participants.
Time frame: Week 12
Part A and Part B: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Time frame: From first dose through Week 12
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