Plaque Psoriasis Patients
Conditions
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.
Interventions
Sponsors
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement | At Week 12 |
| Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) | At Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Contacts
Primary ContactQinghong Zhou
Outcome results
None listed