Real-World Study of Xeligekimab for Moderate to Severe Plaque Psoriasis(XP-Real)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xeligekimab injection.
- Who it may be relevant to
- Registry conditions: Plaque Psoriasis, Psoriatic Arthritis, Scalp Psoriasis, Nail Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effectiveness and Safety of Xeligekimab in Adult Patients With Moderate to Severe Plaque Psoriasis: A Multicenter, Prospective, Real-World Study
Overview
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.
Detailed description
This multicenter, prospective, real-world study will consecutively enroll moderate to severe plaque psoriasis adult patients who are anticipated to receive xeligekimab for the first time. All patients will receive routine clinical care. The study will evaluate the treatment's effectiveness and safety and observe treatment patterns for up to 52 weeks.
Objectives:
Primary Objective:
To evaluate the effectiveness and safety of xeligekimab in adult patients with moderate to severe plaque psoriasis in clinical practice.
Secondary Objective:
To observe the treatment patterns of xeligekimab in adult patients with moderate to severe plaque psoriasis in clinical practice.
Exploratory Objectives:
* To explore the effectiveness of xeligekimab in subgroup patients with psoriatic arthritis. * To explore the effectiveness of xeligekimab in subgroup patients with psoriasis involving special areas (scalp, nails, palmoplantar areas, genital areas, etc.). * To explore the effectiveness of xeligekimab in subgroup patients with comorbidities of psoriasis. * To explore the effectiveness and safety of xeligekimab in subgroup patients with psoriasis who have previously received treatment with other biologic agents.
Interventions
- Drug Xeligekimab injection
This is a real-world study. All treatment regimens are developed and implemented through detailed communication between patients and their treating clinicians. Treatment recommendations are consistent with the medication's prescribing information and treatment guidelines. The recommended dosing for xeligekimab is 200 mg at weeks 0, 2, 4, 6, 8, 10, and 12, followed by every 4 weeks thereafter. Each 200 mg dose is given in 2 separate 100 mg subcutaneous injections. The preferred injection site is
Primary outcome measures
- Psoriasis Area and Severity Index 90 (PASI90) response rate at Week 12 [Time frame: Week 12]
Secondary outcome measures (8)
- PASI90 response rates at Weeks 4, 24, 36, and 52 [Time frame: Weeks 4, 24, 36, and 52]
- PASI75 and PASI100 response rates at Weeks 4, 12, 24, 36, and 52 [Time frame: Weeks 4, 12, 24, 36, and 52]
- Physician's Global Assessment (PGA) 0/1 response rates at Weeks 4, 12, 24, 36, and 52 [Time frame: Weeks 4, 12, 24, 36, and 52]
- Dermatology Life Quality Index (DLQI) 0/1 response rates at Weeks 4, 12, 24, 36, and 52 [Time frame: Weeks 4, 12, 24, 36, and 52]
- Treatment patterns: treatment statuses [Time frame: Weeks 12, 24, 36, and 52]
- Treatment patterns: reasons for non-persistence, discontinuation, switching, and re-initiation of therapy [Time frame: Weeks 12, 24, 36, and 52]
- Treatment patterns: treatment regimens after switching [Time frame: Weeks 12, 24, 36, and 52]
- Adverse Events (AEs) [Time frame: Week 52]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
Patients who meet any of the following exclusion criteria will be excluded from this study:
- Patients with drug-induced psoriasis (such as new-onset or exacerbated psoriasis caused by β-blockers, calcium channel blockers, or lithium);
- Patients with hypersensitivity to the active ingredient or any excipient in xeligekimab injection solution;
- Patients with other contraindications specified in the prescribing information;
- Patients concurrently participating in other clinical studies;
- Patients under other conditions or circumstances that investigators do not consider appropriate to include.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xiangya Hospital of Central South University — Hunan
Identifiers
NCT: NCT06802848 · GRRWS202401