CompletedPhase 2

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

China112 participantsStarted 2021-10-22

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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.

What they're measuring

Proportion of subjects achieving ACR 20 improvement at week 12

Timeframe: at week 12

Trial details

NCT IDNCT05055934

SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-05

View on ClinicalTrials.gov More Psoriatic Arthritis trials