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

Phase 2

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Drug: SHR-1314 injection; Drug: placebo

• Registration Number: NCT05055934
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-09-24
• Study Start: 2021-10-22
• Primary Completion: 2024-06-05
• Study Completion: 2024-06-05
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-1314 injection	SHR-1314 injection	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving ACR 20 improvement at week 12	at week 12

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects who achieved ACR 50 improvement (week 12)	week 12
The proportion of subjects who achieved ACR 70 improvement (week 12)	week 12

Trial Locations

Locations (1)

Huashan Hospital of the Shanghai FuDan University; 🇨🇳 Shanghai, Shanghai, China