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

Last updated: November 8, 2024
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Arthritis And Arthritic Pain

Psoriatic Arthritis

Joint Injuries

Treatment

SHR-1314 injection

Placebo

Clinical Study ID

NCT06640257
SHR-1314-308
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. The subject voluntarily signs an informed consent form before any procedures relatedto the research start;

  2. At the time of screening, it met the 2006 psoriatic arthritis classificationstandard (CASPAR);

  3. There is active PsA before randomization;

  4. Have active plaque psoriasis (at least one plaque skin lesion) at the time ofscreening, or have a history of plaque psoriasis;

  5. Participants who have previously been treated with csDMARDs and/or NSAIDs still haveactive psoriatic arthritis disease.

Exclusion

Exclusion Criteria:

  1. Existence of any of the following medical history or comorbid diseases: drug-inducedpsoriasis; other active inflammatory diseases or autoimmune diseases; history oforgan transplantation; history of lymphocytic proliferation; severe infections, etc.

  2. Have received psoriatic arthritis or psoriasis drugs, such as intra-articularinjections, plant preparations, etc. within a certain period of time in the past.

  3. Those who are allergic to the drug ingredients or excipients in this study, or areallergic to other biological agents.

  4. A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women,etc.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: SHR-1314 injection
Phase: 3
Study Start date:
November 04, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Huashan Hospital of the Shanghai FuDan University

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

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