A Phase 2 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
Psoriasis
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility 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.
Sites / Locations
- Huashan Hospital Fudan University
- Shanghai Dermatology Hospital
- The First Affiliated Hospital of Kunming Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Part 1:608 40 mg
Part 1:608 80 mg
Part 1:608 160 mg
Part 2:608 160 mg W0+80 mg Q2W+80 mg Q4W
Part 2:608 160 mg Q2W+160 mg Q4W
Part 2:608 160 mg Q4W+160 mg Q8W
Part 2:Placebo
Randomized in a 6:2 ratio to 608 40mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 40mg or placebo 4-weekly.
Randomized in a 10:2 ratio to 608 80mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 80mg or placebo 4-weekly.
Randomized in a 10:2 ratio to 608 160mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 160mg or placebo 4-weekly.
Participants will receive starting dose of 160 mg 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection during induction period. During the maintenance period, participants will receive 80mg 608 once every four weeks (Q4W).
Participants will receive 160mg 608 once every two weeks (Q2W) by subcutaneous injection during induction period followed by 160mg 608 once every four weeks (Q4W) during maintenance period.
Participants will receive 160mg 608 once every four weeks (Q4W) by subcutaneous injection during induction period followed by 160mg 608 once every eight weeks (Q8W) during maintenance period.
Participants will receive Placebo by subcutaneous injection.