Inflammatory Skin DiseasesNCT06794671
A Basket Trial of Vunakizumab in Inflammatory Skin Diseases
An observational study of Inflammatory Skin Diseases and Psoriasis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Skin Diseases, Psoriasis
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 31 Dec 2031
- 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: Patients woh had adiagnosis of inflammatory skin disease are receiving or plans to receive vunakizumab for treatment.
Who may be able to join
- aged ≥ years；
- had adiagnosis of inflammatory skin disease；
- Is receiving or plans to receive vunakizumab for treatment;
- Patients provided written informed consent form.
Who cannot join
- no.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Wei Li, PhD contact
About this study
Official title: 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.
- Conditions
- Inflammatory Skin Diseases, Psoriasis
- Keywords
- inflammatory skin diseases, Psoriasis, vunakizumab
- Medical subject headings
- Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in DLQI scores over 52 weeks
DLQI: Dermatology Life Quality Index, range from 0 to 30, with higher scores indicating greater impact on quality of life
Measured: Weeks 0 to 52
Secondary outcomes (3)
Change from baseline in BSA over 52 weeks
BSA: body surface area
Measured: Weeks 0 to 52
Change from baseline in IGA over 52 weeks
IGA: Investigator Global Assessment
Measured: Weeks 0 to 52
Patterns of administration of vunakizumab for the treatment of different inflammatory skin diseases
The dose, interval, duration, and combined treatment of patients receiving vunakizumab were evaluated
Measured: Weeks 0 to 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Skin DiseasesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794671
- Sponsor's protocol ID
- 2024-0999
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Large-sample Case Registry Study to Evaluate Patient-reported Outcome and Medication Patterns With Vunakizumab for Inflammatory Skin Diseases
- ClinicalTrials.gov ID
- NCT06794671
- Acronym / sponsor ID
- 2024-0999
- Conditions
- Inflammatory Skin Diseases, Psoriasis
- Keywords
- inflammatory skin diseases, Psoriasis, vunakizumab
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 27 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients woh had adiagnosis of inflammatory skin disease are receiving or plans to receive vunakizumab for treatment.
Key inclusion criteria (4 listed)
- aged ≥ years；
- had adiagnosis of inflammatory skin disease；
- Is receiving or plans to receive vunakizumab for treatment;
- Patients provided written informed consent form.
Key exclusion criteria (1 listed)
- no.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
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 27 Jan 2025.
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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.
Wei Li, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Skin Diseases and Psoriasis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 4 inclusion and 1 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 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Xiaoyong Man, PhD (86-0571-87783753, manxy@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in DLQI scores over 52 weeks (time frame: Weeks 0 to 52). 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 27 Jan 2025.