NCT06640257 A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis
| NCT ID | NCT06640257 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Psoriatic Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2024-11-04 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06640257 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psoriatic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06640257 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT06640257 currently recruiting?
Yes, NCT06640257 is actively recruiting participants. Contact the research team at su.zhang.sz3@hengrui.com for enrollment information.
Where is the NCT06640257 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06640257 clinical trial?
NCT06640257 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 200 participants.