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NCT Number: NCT06794671

A Basket Trial of Vunakizumab in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from baseline in BSA over 52 weeks

    Time frame: Weeks 0 to 52

    BSA: body surface area

  2. Change from baseline in IGA over 52 weeks

    Time frame: Weeks 0 to 52

    IGA: Investigator Global Assessment

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Li, PhD

CONTACT

[email protected]

Xiaoyong Man, PhD

CONTACT

[email protected]

86-0571-87783753

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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