RecruitingPhase 3NCT06640257

A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis

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

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

200 participants

Start Date

Nov 4, 2024

Study Type

INTERVENTIONAL

Conditions

Psoriatic Arthritis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria4

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.

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