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

Psoriatic Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05055934
• Other study ID #: SHR-1314-204
• Status: Recruiting
• Phase: Phase 2
• Start date: October 22, 2021
• Est. completion date: January 23, 2023

Study information

• Verified date: September 2021
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Siai Sun
• Phone: 18036618062
• Email: siai.sun[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• SHR-1314 injection
SHR-1314 injection
• placebo
placebo

Locations

Country	Name	City	State
China	Huashan Hospital of the Shanghai FuDan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving ACR 20 improvement at week 12		at week 12
Secondary	The proportion of subjects who achieved ACR 50 improvement (week 12)		week 12
Secondary	The proportion of subjects who achieved ACR 70 improvement (week 12)		week 12