NCT06802848

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Chongqing Genrix Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Plaque Psoriasis
• Psoriatic Arthritis
• Scalp Psoriasis
• Nail Psoriasis
• Palmoplantar Psoriasis
• Genital Psoriasis

Interventions

Type	Name	Description
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 the abdomen. Upper arms or thighs are recommended as alternative sites.

Timeline

• Start date: 2025-01-30
• Primary completion: 2026-03-31
• Completion: 2026-12-31
• First posted: 2025-01-31
• Last updated: 2025-01-31

Locations

1 site across 1 country: China