Menu
Not yet recruiting NCT06794671

A Basket Trial of Vunakizumab in Inflammatory Skin Diseases

Observational Inflammatory Skin Diseases Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Inflammatory Skin Diseases, Psoriasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Change from baseline in DLQI scores over 52 weeks [Time frame: Weeks 0 to 52]
Secondary outcome measures (3)
  • Change from baseline in BSA over 52 weeks [Time frame: Weeks 0 to 52]
  • Change from baseline in IGA over 52 weeks [Time frame: Weeks 0 to 52]
  • Patterns of administration of vunakizumab for the treatment of different inflammatory skin diseases [Time frame: Weeks 0 to 52]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06794671 · 2024-0999

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗