NCT06802848Not yet recruiting
Real-World Study of Xeligekimab for Moderate to Severe Plaque Psoriasis(XP-Real)
Effectiveness and Safety of Xeligekimab in Adult Patients With Moderate to Severe Plaque Psoriasis: A Multicenter, Prospective, Real-World Study
Source: ClinicalTrials.gov · Last updated 31 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Xeligekimab Injection was approved in China on August 20, 2024, for treating adults with moderate to severe plaque psoriasis who are candidates for systemic treatment or phototherapy. Despite the promising efficacy and safety shown in the phase III clinical trial, real-world data is needed to further support clinical decisions for this patient group. This study aims to evaluate the effectiveness and safety of xeligekimab in real-world clinical settings for adults with moderate to severe plaque psoriasis.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 14 Jan 2025
- Start date
- 30 Jan 2025
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Chongqing Genrix Biopharmaceutical Co., Ltd
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT06802848
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 30 Jan 2025 to the primary completion date, 31 Mar 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.
Other illness
- Patients with hypersensitivity to the active ingredient or any excipient in xeligekimab injection solution;
- Patients under other conditions or circumstances that investigators do not consider appropriate to include.
Lab values
- Patients with drug-induced psoriasis (such as new-onset or exacerbated psoriasis caused by β-blockers, calcium channel blockers, or lithium);
Other
- Patients who meet any of the following exclusion criteria will be excluded from this study:
- Patients with other contraindications specified in the prescribing information;
- Patients concurrently participating in other clinical studies;
Who the study is looking for
- Patients who meet all the following criteria will be included in this study:
- Patients 18 years of age or older;
- Patients with a confirmed clinical diagnosis of moderate to severe plaque psoriasis at the time of screening;
- Patients who are deemed suitable for xeligekimab therapy by a clinician and are anticipated to receive xeligekimab treatment for the first time;
- Patients who are willing to sign the informed consent form.
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 |
|---|---|---|---|
| Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Hunan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.