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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Plaque Psoriasis; Psoriatic Arthritis; Scalp Psoriasis; Nail Psoriasis; Palmoplantar Psoriasis; Genital Psoriasis
• Intervention / Treatment: Drug: Xeligekimab injection

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Juan Su; Phone Number: +86 15116408921; Email: 3694944834@qq.com

Study Locations

• China
  • Changsha
    • Hunan, Changsha, China, 410008
      • Xiangya Hospital of Central South University
      • Contact: Juan Su; Phone Number: +86 15116408921; Email: 3694944834@qq.com
      • Contact: Xiang Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients with moderate to severe plaque psoriasis who are anticipated to receive treatment with xeligekimab

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Xeligekimab; Patients who are anticipated to receive xeligekimab for the first time

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PASI90 response rates at 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.	Weeks 4, 24, 36, and 52
PASI75 and PASI100 response rates at 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.	Weeks 4, 12, 24, 36, and 52
Physician's Global Assessment (PGA) 0/1 response rates at 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.	Weeks 4, 12, 24, 36, and 52
Dermatology Life Quality Index (DLQI) 0/1 response rates at 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.	Weeks 4, 12, 24, 36, and 52
Treatment patterns: treatment statuses	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.	Weeks 12, 24, 36, and 52
Treatment patterns: reasons for non-persistence, discontinuation, switching, and re-initiation of therapy	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.	Weeks 12, 24, 36, and 52
Treatment patterns: treatment regimens after switching	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.	Weeks 12, 24, 36, and 52
Adverse Events (AEs)	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.	Week 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change and percentage change from baseline in PASI scores at Weeks 4, 12, 24, 36, and 52	The absolute change (PASI score at each observation time point - baseline PASI score) and the percentage change ([PASI score at each observation time point - baseline PASI score] / baseline PASI score * 100%) in PASI scores at Weeks 4, 12, 24, 36, and 52 compared to the baseline.	Weeks 4, 12, 24, 36, and 52
Absolute change and percentage change from baseline in PGA scores at Weeks 4, 12, 24, 36, and 52	The absolute change (PGA score at each observation time point - baseline PGA score) and the percentage change ([PGA score at each observation time point - baseline PGA score] / baseline PGA score * 100%) in PGA score at Weeks 4, 12, 24, 36, and 52 compared to the baseline.	Weeks 4, 12, 24, 36, and 52
Absolute change and percentage change from baseline in DLQI scores at Weeks 4, 12, 24, 36, and 52	The absolute change (DLQI score at each observation time point - baseline DLQI score) and the percentage change ([DLQI score at each observation time point - baseline DLQI score] / baseline DLQI score * 100%) in DLQI score at Weeks 4, 12, 24, 36, and 52 compared to the baseline.	Weeks 4, 12, 24, 36, and 52
Absolute change from baseline in peak pruritus numerical rating scale (NRS) scores at Weeks 4, 12, 24, 36, and 52	The absolute change (peak pruritus NRS score at each observation time point - baseline peak pruritus NRS score) in peak pruritus NRS score at Weeks 4, 12, 24, 36, and 52 compared to the baseline.	Weeks 4, 12, 24, 36, and 52
Absolute change from baseline in Patient Health Questionnaire (PHQ-9) scores at Weeks 4, 12, 24, 36, and 52	The absolute change (PHQ-9 score at each observation time point - baseline PHQ-9 score) in PHQ-9 score at Weeks 4, 12, 24, 36, and 52 compared to the baseline.	Weeks 4, 12, 24, 36, and 52
Absolute change from baseline in Generalized Anxiety Disorder 7-item (GAD-7) scores at Weeks 4, 12, 24, 36, and 52	The absolute change (GAD-7 score at each observation time point - baseline GAD-7 score) in GAD-7 score at Weeks 4, 12, 24, 36, and 52 compared to the baseline.	Weeks 4, 12, 24, 36, and 52
[Only for patients with nail involvement] Physician's Global Assessment Fingernails Psoriasis (PGA-F) 0/1 response rates at Weeks 4, 12, 24, 36, and 52	The proportions of patients achieving a PGA-F score of 0 or 1 at Weeks 4, 12, 24, 36, and 52.	Weeks 4, 12, 24, 36, and 52
[Only for patients with nail involvement] Modified Nail Psoriasis Severity Index 75 (mNAPSI75) response rates at Weeks 4, 12, 24, 36, and 52	The proportions of patients achieving a ≥75% improvement in mNAPSI score at Weeks 4, 12, 24, 36, and 52 compared to the baseline.	Weeks 4, 12, 24, 36, and 52
[Only for patients with scalp involvement] Scalp-specific Physician's Global Assessment (ss-PGA) 0/1 response rates at Weeks 4, 12, 24, 36, and 52	The proportions of patients achieving an ss-PGA score of 0 or 1 at Weeks 4, 12, 24, 36, and 52.	Weeks 4, 12, 24, 36, and 52
[Only for patients with scalp involvement] Psoriasis Scalp Severity Index 75 (PSSI75) response rates at Weeks 4, 12, 24, 36, and 52	The proportions of patients achieving a ≥75% improvement in PSSI score at Weeks 4, 12, 24, 36, and 52 compared to the baseline.	Weeks 4, 12, 24, 36, and 52
[Only for patients with genital involvement] Static Physician's Global Assessment of Genitalia (sPGA-G) 0/1 response rates at Weeks 4, 12, 24, 36, and 52	The proportions of patients achieving an sPGA-G score of 0 or 1 at Weeks 4, 12, 24, 36, and 52.	Weeks 4, 12, 24, 36, and 52
[Only for patients with palmoplantar involvement] Palmoplantar Psoriasis Global Assessment (pp-PGA) 0/1 response rates at Weeks 4, 12, 24, 36, and 52	The proportions of patients achieving a pp-PGA score of 0 or 1 at Weeks 4, 12, 24, 36, and 52.	Weeks 4, 12, 24, 36, and 52
[Only for patients with palmoplantar involvement] Palmoplantar Pustular Psoriasis Area and Severity Index 75 (pp-PASI75) response rates at Weeks 4, 12, 24, 36, and 52	The proportions of patients achieving a ≥75% improvement in pp-PASI score at Weeks 4, 12, 24, 36, and 52 compared to the baseline.	Weeks 4, 12, 24, 36, and 52
[Only for patients with psoriatic arthritis] Proportions of patients achieving Minimal Disease Activity (MDA) at Weeks 4, 12, 24, 36, and 52	The proportions of patients achieving MDA at Weeks 4, 12, 24, 36, and 52. A patient is classified as achieving MDA when meeting 5 out of the following 7 criteria: Tender Joint Count (TJC) ≤1;; Swollen Joint Count (SJC) ≤1;; PASI ≤1 or Body Surface Area (BSA) ≤3;; Patient Pain Visual Analogue Score (VAS) ≤ 15mm;; Patient Global Disease Activity VAS ≤20mm;; Health Assessment Questionnaire (HAQ) score ≤0.5;; Tender Entheseal Points ≤1.	Weeks 4, 12, 24, 36, and 52
[Only for patients with psoriatic arthritis] American College of Rheumatology (ACR) criteria 20 (ACR20), 50 (ACR50), and 75 (ACR75) response rates at Weeks 4, 12, 24, 36, and 52	The proportions of patients achieving a ≥20%, ≥50%, and ≥70% improvement in ACR composite measures of disease state at Weeks 4, 12, 24, 36, and 52 compared to the baseline.	Weeks 4, 12, 24, 36, and 52

Collaborators and Investigators

• Sponsor: Chongqing Genrix Biopharmaceutical Co., Ltd
• Collaborators: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 26, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 26, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Psoriatic Arthritis; Plaque Psoriasis; Scalp Psoriasis; Antibodies, Monoclonal; Nail Psoriasis; IL-17A; Genital Psoriasis; Palmoplantar Psoriasis; Comorbidities of Psoriasis; Xeligekimab; GR1501
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Arthritis; Psoriasis; Arthritis, Psoriatic
• Other Study ID Numbers: GRRWS202401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The sponsor has no individual patient data (IPD) sharing plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No