Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis

Launched by SUZHOU SUNCADIA BIOPHARMACEUTICALS CO., LTD. · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Vunakizumab for people with moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. The trial will involve about 1,564 patients who have already been on other biologic treatments (a type of medication made from living cells) for at least 12 weeks. Researchers want to see how well Vunakizumab works for these patients and if it is safe to use, especially in hard-to-treat areas of the skin.

To participate in this trial, you must be at least 18 years old and diagnosed with moderate to severe plaque psoriasis. You'll need to sign a consent form and be able to communicate with the research team throughout the study. However, there are some criteria that might prevent you from joining, like if you've had serious reactions to similar treatments in the past or have certain active health conditions. If you take part, you can expect to receive Vunakizumab and contribute to understanding how well it works for people like you. The trial is not yet recruiting participants, so there will be more information available soon.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years old at the time of signing the informed consent, regardless of gender;
• • 2. Diagnosed with moderate to severe plaque psoriasis;
• • 3. 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;
• • 4. 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.
• Exclusion Criteria:
• • 1. Patients previously treated with IL-17A inhibitors (IL-17Ai) had primary failure;
• • 2. Patients who had previously used IL-17A inhibitors (IL-17Ai) and experienced drug-related adverse events leading to drug withdrawal;
• • 3. Patients with severe hypersensitivity to the active ingredient or any excipients of Vunakizumab;
• • 4. 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;
• • 5. Patients with clinically important active diseases, such as active tuberculosis, active hepatitis, and active malignant tumors;
• • 6. Any other circumstances that the investigator believes will prevent the subject from following and completing the study protocol.