Study of Stapokibart Injection in Patients With Allergic Rhinitis
NCT ID: NCT06525597
Last Updated: 2024-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2024-09-30
2025-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase II Study of JT002 in the Treatment of Seasonal Allergic Rhinitis in Adults
NCT06861101
A Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
NCT07091357
A Study in Subjects With Perennial Allergic Rhinitis
NCT00210015
Efficacy and Safety of Stapokibart in Non-Allergic Rhinitis With Eosinophilia Syndrome
NCT07240376
A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis
NCT06837233
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stapokibart Group
Stapokibart, subcutaneous, once every two weeks
Stapokibart Injection
IL-4Rα monoclonal antibody
Placebo Group
Placebo, subcutaneous, once every two weeks
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stapokibart Injection
IL-4Rα monoclonal antibody
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
Exclusion Criteria
* 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) ≤ 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.
12 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Keymed Biosciences Co.Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Luo Zhang
Role: PRINCIPAL_INVESTIGATOR
Beijing Tong-Ren hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Luo Zhang
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CM310-107101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.