Plaque PsoriasisNCT06802848
Real-World Study of Xeligekimab for Moderate to Severe Plaque Psoriasis(XP-Real)
An observational study of Plaque Psoriasis and Psoriatic Arthritis, run by Chongqing Genrix Biopharmaceutical Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis, Psoriatic Arthritis, Scalp Psoriasis
- What is being tested?
- Xeligekimab injection
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with moderate to severe plaque psoriasis who are anticipated to receive treatment with xeligekimab
Who may be able to join
- 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.
Who cannot join
- Patients who meet any of the following exclusion criteria will be excluded from this study:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xiangya Hospital of Central South University
Hunan, Changsha, 410008
Juan Su, +86 15116408921, 3694944834@qq.com
Xiang Chen, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Plaque Psoriasis, Psoriatic Arthritis, Scalp Psoriasis, Nail Psoriasis, Palmoplantar Psoriasis, Genital Psoriasis
- Being tested
- Xeligekimab injection
- Keywords
- Plaque Psoriasis, Psoriatic Arthritis, Scalp Psoriasis, Nail Psoriasis, Palmoplantar Psoriasis, Genital Psoriasis, Comorbidities of Psoriasis, Xeligekimab, IL-17A, GR1501, Antibodies, Monoclonal
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeligekimab injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Xeligekimab | Patients who are anticipated to receive xeligekimab for the first time Receives: Drug: Xeligekimab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start30 Jan 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Genrix Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xiangya Hospital of Central South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802848
- Sponsor's protocol ID
- GRRWS202401
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor has no individual patient data (IPD) sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Xeligekimab in Adult Patients With Moderate to Severe Plaque Psoriasis: A Multicenter, Prospective, Real-World Study
- ClinicalTrials.gov ID
- NCT06802848
- Acronym / sponsor ID
- GRRWS202401
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chongqing Genrix Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Xiangya Hospital of Central South University
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xeligekimab | – | Drug: Xeligekimab injectionPatients who are anticipated to receive xeligekimab for the first time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with moderate to severe plaque psoriasis who are anticipated to receive treatment with xeligekimab
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients who meet any of the following exclusion criteria will be excluded from this study:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xeligekimab injectionThis 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. | Drug | Xeligekimab |
Primary outcome
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.
8 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No. The sponsor has no individual patient data (IPD) sharing plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis and Psoriatic Arthritis, run by Chongqing Genrix Biopharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Su (+86 15116408921, 3694944834@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index 90 (PASI90) response rate at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.