A Basket Trial of Vunakizumab in Inflammatory Skin Diseases

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06794671

Enrollment

10000

Registered

2025-01-27

Start date

2025-03-01

Completion date

2031-12-31

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Skin Diseases, Psoriasis

Keywords

inflammatory skin diseases, Psoriasis, vunakizumab

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactXiaoyong Man, PhD

manxy@zju.edu.cn86-0571-87783753

Backup ContactWei Li, PhD

Wei.Li@zju.edu.cn

Outcome results