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

NCT ID: NCT06779097

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1564 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2028-02-29

Brief 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).

Conditions

Moderate to Severe Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vunakizumab (IL-17A inhibitor)

Group Type: EXPERIMENTAL

Vunakizumab (IL-17A inhibitor)

Intervention Type: DRUG

Vunakizumab (IL-17A inhibitor)

Interventions

Vunakizumab (IL-17A inhibitor)

Vunakizumab (IL-17A inhibitor)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Haixue Dai

Role: CONTACT

haixue.dai@hengrui.com

+86 18006296526

Other Identifiers

MA-DER-RWS-002

Identifier Type: -

Identifier Source: org_study_id