A Phase 2 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Immunoglobulins

Criteria

Inclusion Criteria:

• Must be 18 Years to 65 Years, both male and female.

• BMI ≥18 kg/m^2 and ≤32 kg/m^2 ，and male weight ≥50 kg, female weight ≥45 kg during the screening.

• Chronic plaque psoriasis (PSO) for at least 6 months prior to the randomizationas as determined by the investigator..

• Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Static Physician Global Assessment (sPGA) score >=3.

• According to the judgment of the investigator, the subject needs to receive systemic treatment and / or phototherapy (including subjects who have used local treatment, and / or phototherapy, and / or poor control of previous systemic treatment).

• Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.

Exclusion Criteria:

• History of pustular or erythrodermic psoriasis other than plaque psoriasis at screening or baseline.

• History of drug-induced psoriasis.

• Ongoing use of prohibited treatments.

• Have previously received any drug that directly targets IL-17.

• Have concurrent or recent use of any biologic agent within washout periods or <5 half-lives prior to randomization.

• Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), syphilis and/ or active tuberculosis.

• Pregnant or lactating women.