A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Patients With Allergic Rhinitis
Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study is a Randomized, Double-blind, Placebo-controlled phase II clinical study evaluating the efficacy and safety of Stapokibart injection in patients with allergic rhinitis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:
• Able to understand the study and voluntarily sign the Informed consent form.
• Diagnosed Allergic Rhinitis according to the Criteria stated in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition).
• Subjects with asthma must be evaluated by the researcher as having a stable condition.
• Has a positive skin prick test (SPT) or positive antigen-specific serum immunoglobulin E (IgE).
Locations
Other Locations
China
Beijing Tongren Hospital, CMU
RECRUITING
Beijing
Contact Information
Primary
Qian Jia
qianjia@keymedbio.com
028-88610620
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 120
Treatments
Experimental: Stapokibart Group
Stapokibart, subcutaneous, once every two weeks
Placebo_comparator: Placebo Group
Placebo, subcutaneous, once every two weeks
Related Therapeutic Areas
Sponsors
Leads: Keymed Biosciences Co.Ltd