Evaluating SHR-1314 for treating active psoriatic arthritis in adults
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of SHR-1314 Injection in Adults With Active Psoriatic Arthritis
This study is testing a new injection called SHR-1314 to see if it can help adults with active psoriatic arthritis feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06640257 on ClinicalTrials.gov |
What this trial studies
This Phase III clinical trial is a randomized, double-blind, multicenter, placebo-controlled study designed to assess the efficacy and safety of SHR-1314 in adults with active psoriatic arthritis. The study includes a 4-week screening period, followed by a 24-week core treatment phase and a 24-week maintenance phase, concluding with an 8-week safety follow-up. A total of 150 adult participants will be enrolled, who will receive either SHR-1314 injections or a placebo. The trial aims to determine the effectiveness of SHR-1314 in managing symptoms of psoriatic arthritis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with active psoriatic arthritis who have not responded adequately to previous treatments.
Not a fit: Patients with other active inflammatory diseases or those who have recently received specific psoriatic arthritis treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of symptoms for patients with active psoriatic arthritis.
How similar studies have performed: Other studies have shown promising results with similar biologic treatments for psoriatic arthritis, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Huashan Hospital of the Shanghai FuDan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Su Zhang, M.M
- Email: su.zhang.sz3@hengrui.com
- Phone: 0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.