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

• Status: Not yet recruiting
• Trial end date: 2023-01-23
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Criteria

Inclusion Criteria:

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

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

3. At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR);

4. There is active PsA before randomization;

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

Exclusion Criteria:

1. 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.

2. Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, 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 are allergic to other biological agents.

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