NCT05055934CompletedPhase 2
Study of the Effectiveness and Safety of SHR-1314 for Psoriatic Arthritis
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Dose Exploratory Study to Evaluate the Effectiveness and Safety of SHR-1314 Injection in Adult Subjects With Active Psoriatic Arthritis
Source: ClinicalTrials.gov · Last updated 12 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 112 (actual)
- First submitted
- 15 Sept 2021
- Start date
- Oct 2021
- Primary completion date
- Jun 2024
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT05055934
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 112
- From Oct 2021 to the primary completion date, Jun 2024
- 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;
- 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;
Age in the registry: 18 years to 75 years · 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 |
Related publications
- Vunakizumab in patients with active psoriatic arthritis: a multicentre, randomized, double-blind, placebo-controlled, phase 2 study.Rheumatology (Oxford) · 2026 · PMID 41632483
This page is information, not medical advice. Discuss any trial with your doctor.