Evaluating Stapokibart Injection for Allergic Rhinitis
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Patients With Allergic Rhinitis
PHASE2 · Keymed Biosciences Co.Ltd · NCT06525597
This study is testing if a new injection called Stapokibart can help people with allergic rhinitis feel better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Sponsor | Keymed Biosciences Co.Ltd (industry) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06525597 on ClinicalTrials.gov |
What this trial studies
This phase II clinical study investigates the efficacy and safety of Stapokibart injection in patients diagnosed with allergic rhinitis. The study employs a randomized, double-blind, placebo-controlled design to ensure reliable results. Participants will be assessed based on their allergic rhinitis diagnosis and response to the treatment. The study aims to provide insights into a new therapeutic option for managing this chronic condition.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with allergic rhinitis who meet specific inclusion criteria, including a positive skin prick test or positive serum IgE.
Not a fit: Patients who have recently used certain monoclonal antibodies or investigational products may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from allergic rhinitis.
How similar studies have performed: Other studies have shown promise with similar biologic approaches for allergic conditions, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * Use of anti-interleukin 4 receptor alpha subunit (IL-4Rα) 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) ≤ 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tongren Hospital, CMU — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Luo Zhang — Beijing Tong-Ren hospital
- Study coordinator: Qian Jia
- Email: qianjia@keymedbio.com
- Phone: 028-88610620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Allergic Rhinitis