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OpenTrials
Active, not recruiting

NCT Number: NCT06640257

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huashan Hospital of the Shanghai FuDan University

Shanghai, Shanghai Municipality, 200433, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-1314 injection

Drug

SHR-1314 injection

Placebo

Drug

Placebo

Primary outcomes

  1. Proportion of subjects achieving ACR 20 improvement at week 24

    Time frame: Week 24

Secondary outcomes

  1. The proportion of subjects who achieved ACR 50 improvement

    Time frame: Week 24

  2. The proportion of subjects who achieved ACR 70 improvement

    Time frame: Week 24

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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