A Single-arm/Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female subjects age 18 years or older;
• Diagnosed with EGPA for at least 6 months;
• History of relapsing or refractory EGPA；
• Stable dose of oral prednisone of ≥7.5 mg/day (but not \>50 mg/day) for at least 4 weeks prior to randomization;
• If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.
Locations
Other Locations
China
Beijing Hospital
RECRUITING
Beijing
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Siai Sun
siai.sun@hengrui.com
0518-82342973
Time Frame
Start Date: 2023-11-16
Estimated Completion Date: 2027-05-16
Participants
Target number of participants: 112
Treatments
Experimental: Treatment group A
SHR-1703
Placebo_comparator: Treatment group B
SHR-1703 Placebo
Related Therapeutic Areas
Sponsors
Leads: Guangdong Hengrui Pharmaceutical Co., Ltd