A Multicenter,Randomized,Phase 3 Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
Overview
- Phase
- Phase 3
- Intervention
- 608 Q2W
- Conditions
- Plaque Psoriasis Patients
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Enrollment
- 750
- Primary Endpoint
- Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years old, both male and female.
- •Diagnosis of plaque psoriasis according to the Chinese Guideline for the Diagnosis and Treatment of Psoriasis (2018).
Exclusion Criteria
- •Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) .
- •Other inflammatory diseases.
- •Active autoimmune diseases.
- •Pregnant or lactating women.
Arms & Interventions
608 160 mg W0+80 mg Q2W
Participants will receive starting dose of 160 milligrams (mg) 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection for 12 weeks.
Intervention: 608 Q2W
608 160 mg Q4W
Participants will receive 160 milligrams 608 once every four weeks (Q4W) by subcutaneous injection for 12 weeks.
Intervention: 608 Q4W
Outcomes
Primary Outcomes
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Time Frame: At Week 12
Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
Time Frame: At Week 12
Secondary Outcomes
- Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)(At Week 12)
- Percentage of Participants Achieving a ≥100% Improvement in Psoriasis Area and Severity Index (PASI 100)(At Week 12)
- Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0)(At Week 12)
- Adverse events (AE)(20 weeks)