NCT06640257Active, not recruitingPhase 3
A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis
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
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 208 (actual)
- First submitted
- 10 Oct 2024
- Start date
- 4 Nov 2024
- Primary completion date
- 5 Jun 2026
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT06640257
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 208
- From 4 Nov 2024 to the primary completion date, 5 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.
Other illness
- 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.
- 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.
Who the study is looking for
- The subject voluntarily signs an informed consent form before any procedures related to the research start;
- 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;
- Participants who have previously been treated with csDMARDs and/or NSAIDs still have active psoriatic arthritis disease.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital of the Shanghai FuDan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.