A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Placebo; Drug: SHR-1314 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06640257

SHR-1314-308

Details and patient eligibility

About

This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical study, consisting of a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 150 adult subjects with psoriatic arthritis.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subject voluntarily signs an informed consent form before any procedures related to the research start;
2. At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR)；
3. There is active PsA before randomization;
4. Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;
5. Participants who have previously been treated with csDMARDs and/or NSAIDs still have active psoriatic arthritis disease.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

SHR-1314 injection

Experimental group

Treatment:

Drug: SHR-1314 injection

placebo

Placebo Comparator group

Treatment:

Drug: SHR-1314 injection

Drug: Placebo