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

Chongqing Genrix Biopharmaceutical Co., Ltd

Status: Not yet enrolling

Conditions: Scalp Psoriasis; Palmoplantar Psoriasis; Plaque Psoriasis; Psoriatic Arthritis; Genital Psoriasis; Nail Psoriasis

Treatments: Drug: Xeligekimab injection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06802848

GRRWS202401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Patients who meet any of the following exclusion criteria will be excluded from this study:

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.

Trial design

1,000 participants in 1 patient group

Xeligekimab

Description:

Patients who are anticipated to receive xeligekimab for the first time

Treatment:

Drug: Xeligekimab injection