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

NCT06802848 | Not Yet Recruiting

• 1 other identifier: GRRWS202401
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Plaque Psoriasis; Psoriatic Arthritis; Scalp Psoriasis; Nail Psoriasis; Palmoplantar Psoriasis; Genital Psoriasis; Comorbidities of Psoriasis; Xeligekimab; IL-17A; GR1501; Antibodies, Monoclonal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• PASI90 response rates at Weeks 4, 24, 36, and 52

  Weeks 4, 24, 36, and 52

• PASI75 and PASI100 response rates at Weeks 4, 12, 24, 36, and 52

  Weeks 4, 12, 24, 36, and 52

• Physician's Global Assessment (PGA) 0/1 response rates 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

  Weeks 4, 12, 24, 36, and 52

• Treatment patterns: treatment statuses

  Weeks 12, 24, 36, and 52

Other Outcomes (15)

• Absolute change and percentage change from baseline in PASI scores at Weeks 4, 12, 24, 36, and 52

  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

  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

  Weeks 4, 12, 24, 36, and 52

Study Arms (1)

Xeligekimab

Patients who are anticipated to receive xeligekimab for the first time

Drug: Xeligekimab injection

Interventions

Xeligekimab injection 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.

Xeligekimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients who meet all the following criteria will be included in this study:
• Patients 18 years of age or older;
• Patients with a confirmed clinical diagnosis of moderate to severe plaque psoriasis at the time of screening;
• Patients who are deemed suitable for xeligekimab therapy by a clinician and are anticipated to receive xeligekimab treatment for the first time;
• Patients who are willing to sign the informed consent form.

You may not qualify if:

• Patients with drug-induced psoriasis (such as new-onset or exacerbated psoriasis caused by β-blockers, calcium channel blockers, or lithium);
• Patients with hypersensitivity to the active ingredient or any excipient in xeligekimab injection solution;
• Patients with other contraindications specified in the prescribing information;
• Patients concurrently participating in other clinical studies;
• Patients under other conditions or circumstances that investigators do not consider appropriate to include.

Sponsors & Collaborators

• Chongqing Genrix Biopharmaceutical Co., Ltd: lead
• Xiangya Hospital of Central South University: collaborator

Study Sites (1)

Xiangya Hospital of Central South University

Hunan, Changsha, 410008, China

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Juan Su

CONTACT

+86 15116408921; 3694944834@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 31, 2025
• Study Start: January 30, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)