An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO
Phase 3
Not yet recruiting
- Conditions
- Plaque Psoriasis Patients
- Interventions
- Drug: 608 Q2WDrug: 608 Q4W
- Registration Number
- NCT06299982
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 750
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 608 160 mg W0+80 mg Q2W 608 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. 608 160 mg Q4W 608 Q4W Participants will receive 160 milligrams 608 once every four weeks (Q4W) by subcutaneous injection for 12 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) 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 At Week 12
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does the recombinant anti-IL-17A humanized monoclonal antibody modulate in moderate-to-severe plaque psoriasis patients?
How does recombinant anti-IL-17A antibody compare to TNF inhibitors and IL-23 inhibitors in Chinese moderate-to-severe plaque psoriasis patients?
Which biomarkers, such as Th17 cell activity or IL-17A receptor expression, predict response to recombinant anti-IL-17A monoclonal antibody in NCT06299982?
What are the potential adverse events of recombinant anti-IL-17A antibody in psoriasis patients, and what management strategies are recommended?
What are the key differences between Sunshine Guojian's recombinant anti-IL-17A antibody and other IL-17A inhibitors like secukinumab in Asia's plaque psoriasis treatment?