NCT06696417Recruiting
Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis
A Prospective, Single-arm, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Vunakizumab in Adults With Moderate-to-severe Plaque Psoriasis Who Have Not Previously Received Biologics
Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a multicenter, prospective, observational study of 1516 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of vunakizumab in patients with moderate-to-severe chronic plaque psoriasis. Approximately 50-100 clinical trial centers are planned to participate in the study. The study consisted of a 7-day screening period, a 52-week treatment period and an 8-week safety follow-up period. The recommended dose of vunakizumab is 240 mg (120 mg in two injections), with subcutaneous injection at week 0, 2, and 4, followed by a dose every 4 weeks and a final injection at week 48 (the actual treatment regimen is based on the clinician's recommendation). After the corresponding assessment at 52 weeks, an 8-week safety follow-up period was entered until the end of the study.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1516 (estimated)
- First submitted
- 12 Nov 2024
- Start date
- 17 Feb 2025
- Primary completion date
- Apr 2028
- Lead sponsor
- First Hospital of China Medical University
- Diseases
- Psoriasis
- NCT number
- NCT06696417
What you commit to
- Study type: Observational
- Planned participants: 1516
- From 17 Feb 2025 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with biological agents: including but not limited to anti-tumor necrosis factor-α (TNF-α), anti-IL-17, anti-IL-17 receptor, anti-IL-12 /IL-23 or IL-23p19 antibody drugs;
- Fertile women (defined as all women with physical conditions necessary for pregnancy) and men who are pregnant or unwilling or unable to use highly effective birth control during the study period and within 20 weeks after last receiving the study drug;
Other illness
- Severe hypersensitivity to vunakizumab active ingredient or any excipients;
- Patients with clinically important active diseases, such as active tuberculosis, active hepatitis, and active malignant tumors;
Other
- Any other circumstances that the investigator believes will prevent the subject from following and completing the study protocol.
Who the study is looking for
- Age ≥18 years old at the time of signing the informed consent, regardless of gender;
- Moderate to severe plaque psoriasis was diagnosed;
- Plan to receive vunakizumab therapy as assessed by the investigator;
- The subject voluntarily signs informed consent before the start of any procedures related to the study, can communicate with the researcher smoothly, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study; Patients voluntarily sign informed consent forms.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.