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Completed

NCT Number: NCT05055934

Study of the Effectiveness and Safety of SHR-1314 for Psoriatic Arthritis

This study is a randomized, double-blind, multicenter, placebo-controlled Phase II clinical study, consisting of a 4-week screening period, a 12-week core treatment period, a 12-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 111 adult subjects with psoriatic arthritis.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

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;
  • Age ≥18 years old and ≤75 years old at the time of signing the informed consent form, regardless of gender;
  • 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;

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 12

    Time frame: at week 12

Secondary outcomes

  1. The proportion of subjects who achieved ACR 50 improvement (week 12)

    Time frame: week 12

  2. The proportion of subjects who achieved ACR 70 improvement (week 12)

    Time frame: week 12

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Dose Exploratory Study to Evaluate the Effectiveness and Safety of SHR-1314 Injection in Adult Subjects With Active Psoriatic Arthritis

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 24, 2021
Registry last updated
Dec 12, 2024

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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