NCT06779097Not yet recruitingPhase 4
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 Converted From Other Biologics
Source: ClinicalTrials.gov · Last updated 16 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a prospective, single-arm, multicenter, Phase IV study of 1564 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of Vunakizumab in patients with moderate-to-severe plaque psoriasis who have converted from other biologics. To explore the efficacy of difficult-to-treat area, patient satisfaction and patient-reported outcomes (PRO).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1564 (estimated)
- First submitted
- 7 Jan 2025
- Start date
- Feb 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Psoriasis
- NCT number
- NCT06779097
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1564
- From Feb 2025 to the primary completion date, Mar 2027
- 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
- Patients previously treated with IL-17A inhibitors (IL-17Ai) had primary failure;
- Patients who had previously used IL-17A inhibitors (IL-17Ai) and experienced drug-related adverse events leading to drug withdrawal;
Other illness
- Patients with severe hypersensitivity to the active ingredient or any excipients of Vunakizumab;
- 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 the last receipt of the study drug;
- 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;
- Diagnosed with moderate to severe plaque psoriasis;
- 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 who have been treated with biologics for ≥12 weeks prior to screening and are in line with the biologics conversion recommendations of the Chinese Guidelines for the Treatment of Psoriasis Biologics and Small Molecule Drugs (2024 edition), and who have been screened and evaluated by researchers as eligible for biologics therapy.
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 |
|---|---|---|---|
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.