Actively Recruiting
Study of Stapokibart Injection in Patients With Allergic Rhinitis
Led by Keymed Biosciences Co.Ltd · Updated on 2024-11-08
120
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Stapokibart Injection in Patients With Allergic Rhinitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
You will not qualify if you...
- Use of anti-interleukin 4 receptor alpha subunit (IL-4Rb1) monoclonal antibody, thymic stromal lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonal antibody, other monoclonal antibodies, or other biologics within 10 weeks or 5 half-lives (whichever is longer) prior to the screening visit.
- Use of any investigational product within 4 weeks prior to the screening visit or planning to participate in other clinical studies during this study.
- Forced expiratory volume in 1 second (FEV1) 64 50% of the predicted value during the screening/run-in period.
- Have acute sinusitis, nasal infection, or upper respiratory tract infection at screening or within 2 weeks prior to screening.
- Have received a live-attenuated vaccine within 12 weeks prior to randomization or planning to receive one during the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Q
Qian Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here