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Clinical Trials in China / NCT06779097
Starting soon Phase 4

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

NCT06779097 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Phase
Phase 4
Started
2025-02
Last updated
2025-01-16

Condition(s) studied

Moderate to Severe Plaque Psoriasis

Investigational drug(s) / intervention(s)

Vunakizumab (IL-17A inhibitor)

Vunakizumab (IL-17A inhibitor): Vunakizumab (IL-17A inhibitor)

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing Beijing Municipality

More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06779097 on ClinicalTrials.gov ↗ ← All trials in China