A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of SHR-1314 Injection in Adults With Active Psoriatic Arthritis

Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country200 target enrollmentNovember 4, 2024

ConditionsPsoriatic Arthritis

InterventionsSHR-1314 injection Placebo

Overview

Phase: Phase 3
Intervention: SHR-1314 injection
Conditions: Psoriatic Arthritis
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 200
Locations: 1
Primary Endpoint: Proportion of subjects achieving ACR 20 improvement at week 24
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical study, consisting of a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 150 adult subjects with psoriatic arthritis.

Registry

clinicaltrials.gov

Start Date

November 4, 2024

End Date

June 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subject voluntarily signs an informed consent form before any procedures related to the research start;
•At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR)；
•There is active PsA before randomization;
•Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;
•Participants who have previously been treated with csDMARDs and/or NSAIDs still have active psoriatic arthritis disease.

Exclusion Criteria

•Existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc.
•Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.
•Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents.
•A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.