A Basket Trial of Vunakizumab in Inflammatory Skin Diseases

January 21, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Multicenter, Large-sample Case Registry Study to Evaluate Patient-reported Outcome and Medication Patterns With Vunakizumab for Inflammatory Skin Diseases

This is a national multi-center, large sample size case registration clinical study. The registry population was patients with inflammatory skin diseases who were receiving treatment with vunakizumab. All outpatient and inpatient patients with inflammatory skin diseases who were receiving vunakizumab were eligible for enrollment. Patients' usual care was not affected by participation in the study. We only collected data in routine clinical practice.

The study had an enrollment period of 5 years or 10,000 patients were recruited early, whichever occurred first. All patients must provide written informed consent form before data collection, and each patient will be followed for 1 year to observe clinical progression.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaoyong Man, PhD
  • Phone Number: 86-0571-87783753
  • Email: manxy@zju.edu.cn

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients woh had adiagnosis of inflammatory skin disease are receiving or plans to receive vunakizumab for treatment.

Description

Inclusion Criteria:

  • aged ≥ years；
  • had adiagnosis of inflammatory skin disease；
  • Is receiving or plans to receive vunakizumab for treatment;
  • Patients provided written informed consent form.

Exclusion Criteria:

  • no.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in DLQI scores over 52 weeks
Time Frame: Weeks 0 to 52
DLQI: Dermatology Life Quality Index, range from 0 to 30, with higher scores indicating greater impact on quality of life
Weeks 0 to 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in BSA over 52 weeks
Time Frame: Weeks 0 to 52
BSA: body surface area
Weeks 0 to 52
Change from baseline in IGA over 52 weeks
Time Frame: Weeks 0 to 52
IGA: Investigator Global Assessment
Weeks 0 to 52
Patterns of administration of vunakizumab for the treatment of different inflammatory skin diseases
Time Frame: Weeks 0 to 52
The dose, interval, duration, and combined treatment of patients receiving vunakizumab were evaluated
Weeks 0 to 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

January 5, 2025

First Submitted That Met QC Criteria

January 21, 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 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0999

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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