A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis
Recruiting
Phase 3Interventional Study
Psoriatic Arthritis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
Who this trial is looking for
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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.
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Eligibility Criteria
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 ps…
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.
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