Study on the Treatment of Adolescent Patients With Seasonal Allergic Rhinitis (NCT07678931) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Study on the Treatment of Adolescent Patients With Seasonal Allergic Rhinitis
China136 participantsStarted 2026-08
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study aimed at evaluating the efficacy and safety of stapokibart in adolescent patients with seasonal allergic rhinitis, and observing the quality of life, Pharmakokinetics(PK), Pharmacodynamics (PD) characteristics, and immunogenicity of subjects.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age range: ≥12 years to \<18 years
* Voluntarily sign the informed consent form.
* Seasonal allergic rhinitis has been prevalent for at least 2 years.Positive for allergens associated with seasonal allergic rhinitis.
* Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
* Weight≥40kg.
* Symptom severity scores for the season met the enrollment criteria.
Exclusion Criteria:
* Subjects who received anti-interleukin-4 receptor alpha(anti-IL-4Rα), anti-thymic stromal lymphopoietin(anti-TSLP), anti-immunoglobulin E(anti-IgE) monoclonal antibodies or other biologics within 10 weeks or 5 half-lives prior to screening (whichever is longer), or have a history of inadequate therapeutic response or intolerance to prior anti-IL-4Rα monoclonal antibody treatment for seasonal allergic rhinitis.
* Subjects with known hypersensitivity to stapokibart, any anti-IL-4Rα monoclonal antibody, or any ingredients of background concomitant medications.
* Subjects who newly initiate allergen-specific immunotherapy within 3 months before screening or intend to receive such therapy during the trial, or whose allergen exposure at home or workplace is expected to change significantly throughout the study period.
* Subjects with poorly controlled recent asthma or concomitant severe asthma with percent predicted Forced Expiratory Volume in one second(FEV1) ≤50% at screening.
* Subjects presentin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment