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

Last updated: January 14, 2025
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

4

Condition

Warts

Rash

Skin Wounds

Treatment

Vunakizumab (IL-17A inhibitor)

Clinical Study ID

NCT06779097
MA-DER-RWS-002
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 proceduresrelated to the study, can communicate with the researcher smoothly, understands andis willing to strictly comply with the requirements of this clinical study protocolto complete the study;

  4. Patients who have been treated with biologics for ≥12 weeks prior to screening andare in line with the biologics conversion recommendations of the Chinese Guidelinesfor the Treatment of Psoriasis Biologics and Small Molecule Drugs (2024 edition),and who have been screened and evaluated by researchers as eligible for biologicstherapy.

Exclusion

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 experienceddrug-related adverse events leading to drug withdrawal;

  3. Patients with severe hypersensitivity to the active ingredient or any excipients ofVunakizumab;

  4. Fertile women (defined as all women with physical conditions necessary forpregnancy) and men who are pregnant or unwilling or unable to use highly effectivebirth control during the study period and within 20 weeks after the last receipt ofthe 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 fromfollowing and completing the study protocol.

Study Design

Total Participants: 1564
Treatment Group(s): 1
Primary Treatment: Vunakizumab (IL-17A inhibitor)
Phase: 4
Study Start date:
February 01, 2025
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • China-Japan Friendship Hospital

    Beijing, Beijing 100029
    China

    Site Not Available

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