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

Not yet recruiting

• Conditions: Plaque Psoriasis; Psoriatic Arthritis; Scalp Psoriasis; Nail Psoriasis; Palmoplantar Psoriasis; Genital Psoriasis
• Interventions: Drug: Xeligekimab injection

• Registration Number: NCT06802848
• Lead Sponsor: Chongqing Genrix Biopharmaceutical Co., Ltd

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-26
• Last Update Submitted: 2025-01-26
• Study Start: 2025-01-30
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-03-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Xeligekimab	Xeligekimab injection	Patients who are anticipated to receive xeligekimab for the first time

Primary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index 90 (PASI90) response rate at Week 12	Week 12	The proportion of patients achieving a ≥90% improvement in PASI score at Week 12 compared to the baseline.

Secondary Outcome Measures

Name	Time	Method
PASI90 response rates at Weeks 4, 24, 36, and 52	Weeks 4, 24, 36, and 52	The proportions of patients achieving a ≥90% improvement in PASI score at Weeks 4, 24, 36, and 52 compared to the baseline.
PASI75 and PASI100 response rates at Weeks 4, 12, 24, 36, and 52	Weeks 4, 12, 24, 36, and 52	The proportions of patients achieving a ≥75% improvement and those achieving a 100% improvement in PASI score at Weeks 4, 12, 24, 36, and 52 compared to the baseline.
Physician's Global Assessment (PGA) 0/1 response rates at Weeks 4, 12, 24, 36, and 52	Weeks 4, 12, 24, 36, and 52	The proportions of patients achieving a PGA score of 0 or 1 at Weeks 4, 12, 24, 36, and 52.
Dermatology Life Quality Index (DLQI) 0/1 response rates at Weeks 4, 12, 24, 36, and 52	Weeks 4, 12, 24, 36, and 52	The proportions of patients achieving a DLQI score of 0 or 1 at Weeks 4, 12, 24, 36, and 52.
Treatment patterns: treatment statuses	Weeks 12, 24, 36, and 52	The proportions of patients with different treatment statuses (including adherence, persistence, non-persistence, discontinuation, switching, and re-initiation of therapy) will be recorded by the investigators at Weeks 12, 24, 36, and 52.
Treatment patterns: reasons for non-persistence, discontinuation, switching, and re-initiation of therapy	Weeks 12, 24, 36, and 52	The proportions of patients with different treatment statuses (non-persistence, discontinuation, switching, and re-initiation of therapy) categorized by reasons will be recorded by the investigators at Weeks 12, 24, 36, and 52.
Treatment patterns: treatment regimens after switching	Weeks 12, 24, 36, and 52	The proportions of patients who receive different treatment regimens following a switch from xeligekimab will be recorded by the investigators at Weeks 12, 24, 36, and 52.
Adverse Events (AEs)	Week 52	All AEs occurring after the initiation of treatment will be recorded. Investigators should assess the causal relationship between the AEs and the treatment to identify Treatment-Related AEs (TRAEs). The severity of adverse events will be evaluated according to CTCAE Version 5.0. Additionally, Serious Adverse Events (SAEs) and AEs leading to the temporary suspension or permanent discontinuation of the study treatment will be recorded.

Trial Locations

Locations (1)

Xiangya Hospital of Central South University; 🇨🇳 Hunan, Changsha, China