Clinical trial NCT06802848: Real-World Study of Xeligekimab for Moderate to Severe Plaque Psoriasis(XP-Real)
Official title: Effectiveness and Safety of Xeligekimab in Adult Patients With Moderate to Severe Plaque Psoriasis: A Multicenter, Prospective, Real-World Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Chongqing Genrix Biopharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Xiangya Hospital of Central South University
First posted: 2025-01-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with moderate to severe plaque psoriasis who are anticipated to receive treatment with xeligekimab

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.

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:

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.

Primary outcomes:
measure: Psoriasis Area and Severity Index 90 (PASI90) response rate at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: PASI90 response rates at Weeks 4, 24, 36, and 52
timeFrame: Weeks 4, 24, 36, and 52
measure: PASI75 and PASI100 response rates at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Physician's Global Assessment (PGA) 0/1 response rates at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Dermatology Life Quality Index (DLQI) 0/1 response rates at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Treatment patterns: treatment statuses
timeFrame: Weeks 12, 24, 36, and 52
measure: Treatment patterns: reasons for non-persistence, discontinuation, switching, and re-initiation of therapy
timeFrame: Weeks 12, 24, 36, and 52
measure: Treatment patterns: treatment regimens after switching
timeFrame: Weeks 12, 24, 36, and 52
measure: Adverse Events (AEs)
timeFrame: Week 52
Other outcomes:
measure: Absolute change and percentage change from baseline in PASI scores at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Absolute change and percentage change from baseline in PGA scores at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Absolute change and percentage change from baseline in DLQI scores at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Absolute change from baseline in peak pruritus numerical rating scale (NRS) scores at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Absolute change from baseline in Patient Health Questionnaire (PHQ-9) scores at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Absolute change from baseline in Generalized Anxiety Disorder 7-item (GAD-7) scores at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: [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
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: [Only for patients with nail involvement] Modified Nail Psoriasis Severity Index 75 (mNAPSI75) response rates at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: [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
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: [Only for patients with scalp involvement] Psoriasis Scalp Severity Index 75 (PSSI75) response rates at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: [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
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: [Only for patients with palmoplantar involvement] Palmoplantar Psoriasis Global Assessment (pp-PGA) 0/1 response rates at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: [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
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: [Only for patients with psoriatic arthritis] Proportions of patients achieving Minimal Disease Activity (MDA) at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: [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
timeFrame: Weeks 4, 12, 24, 36, and 52
Locations:
city: Hunan
country: China
facility: Xiangya Hospital of Central South University
state: Changsha
Study officials:
References: