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 Q2W; Drug: 608 Q4W

• Registration Number: NCT06299982
• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08
• Study Start: 2024-05-15
• Primary Completion: 2025-01-30
• Study Completion: 2025-03-20

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