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

NCT ID: NCT06802848

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Xeligekimab

Patients who are anticipated to receive xeligekimab for the first time

Xeligekimab injection

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients who meet all the following criteria will be included in this study:

1. Patients 18 years of age or older;

2. Patients with a confirmed clinical diagnosis of moderate to severe plaque psoriasis at the time of screening;

3. Patients who are deemed suitable for xeligekimab therapy by a clinician and are anticipated to receive xeligekimab treatment for the first time;

4. Patients who are willing to sign the informed consent form.

Exclusion Criteria

1. Patients with drug-induced psoriasis (such as new-onset or exacerbated psoriasis caused by β-blockers, calcium channel blockers, or lithium);

2. Patients with hypersensitivity to the active ingredient or any excipient in xeligekimab injection solution;

3. Patients with other contraindications specified in the prescribing information;

4. Patients concurrently participating in other clinical studies;

5. Patients under other conditions or circumstances that investigators do not consider appropriate to include.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiangya Hospital of Central South University

Hunan, Changsha, China

Countries

China

Central Contacts

Juan Su

Role: CONTACT

3694944834@qq.com

+86 15116408921

Facility Contacts

Juan Su

Role: primary

3694944834@qq.com

+86 15116408921

Other Identifiers

GRRWS202401

Identifier Type: -

Identifier Source: org_study_id