---
title: Real-World Study of Xeligekimab for Moderate to Severe Plaque Psoriasis(XP-Real)
nct_id: NCT06802848
overall_status: NOT_YET_RECRUITING
sponsor: Chongqing Genrix Biopharmaceutical Co., Ltd
study_type: OBSERVATIONAL
primary_condition: Plaque Psoriasis
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06802848.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06802848"
ct_last_update_post_date: 2025-01-31
last_seen_at: "2026-05-12T06:44:22.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT06802848](https://clinicaltrials.gov/study/NCT06802848)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 1000
- **Lead Sponsor:** Chongqing Genrix Biopharmaceutical Co., Ltd
- **Collaborators:** Xiangya Hospital of Central South University
- **Conditions:** Plaque Psoriasis, Psoriatic Arthritis, Scalp Psoriasis, Nail Psoriasis, Palmoplantar Psoriasis, Genital Psoriasis
- **Start Date:** 2025-01-30
- **Completion Date:** 2026-12-31
- **CT.gov Last Update:** 2025-01-31

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Xeligekimab** — Patients who are anticipated to receive xeligekimab for the first time

## 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.

## Primary Outcomes

- **Psoriasis Area and Severity Index 90 (PASI90) response rate at Week 12** _(time frame: Week 12)_ — The proportion of patients achieving a ≥90% improvement in PASI score at Week 12 compared to the baseline.

## Secondary Outcomes

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

## Locations (1)

- Xiangya Hospital of Central South University, Hunan, Changsha, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.xiangya hospital of central south university|hunan|changsha|china` — added _(2026-05-12)_

---

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