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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country112 target enrollmentOctober 22, 2021

ConditionsPsoriatic Arthritis

InterventionsSHR-1314 injection placebo

DrugsSHR-1314 injection placebo

Overview

Phase: Phase 2
Intervention: SHR-1314 injection
Conditions: Psoriatic Arthritis
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 112
Locations: 1
Primary Endpoint: Proportion of subjects achieving ACR 20 improvement at week 12
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 22, 2021

End Date

June 5, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.