Real-World Study of Xeligekimab for Moderate to Severe Plaque Psoriasis(XP-Real)

Sponsor
Chongqing Genrix Biopharmaceutical Co., Ltd
Study ID
NCT06802848
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Xeligekimab injection — DRUG
    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 the abdomen. Upper arms or thighs are recommended as alternative sites.

Study Details

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.

Key Dates

First listed
Jan 31, 2025
Start date
Jan 30, 2025
Status verified
Jan 2025
Primary completion
Mar 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Xeligekimab
    Patients who are anticipated to receive xeligekimab for the first time

Primary Outcome Measure

Psoriasis Area and Severity Index 90 (PASI90) response rate at Week 12 [ Time Frame: Week 12 ]

Central Contacts

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