NCT06525597 Study of Stapokibart Injection in Patients With Allergic Rhinitis
| NCT ID | NCT06525597 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Keymed Biosciences Co.Ltd |
| Condition | Allergic Rhinitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2024-09-30 with a primary completion date of 2025-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Luo Zhang
PRINCIPAL INVESTIGATOR
Beijing Tong-Ren hospital
Frequently Asked Questions
Who can join the NCT06525597 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 65 Years, studying Allergic Rhinitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06525597 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06525597 currently recruiting?
Yes, NCT06525597 is actively recruiting participants. Contact the research team at qianjia@keymedbio.com for enrollment information.
Where is the NCT06525597 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06525597 clinical trial?
NCT06525597 is sponsored by Keymed Biosciences Co.Ltd. The principal investigator is Luo Zhang at Beijing Tong-Ren hospital. The trial plans to enroll 120 participants.