Adolescent seasonal allergic rhinitis: add-on therapy with stapokibart vs placebo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a multicenter, randomized, double-blind study, adolescents with seasonal allergic rhinitis receive either stapokibart or placebo as an add-on to their usual care during the pollen season. The trial measures efficacy and safety, plus quality of life, pharmacokinetics, pharmacodynamics, and immunogenicity. All participants continue standard treatments for allergies as background therapy. The study aims to determine if stapokibart provides additional relief beyond current care. Enrollment targets patients with at least two years of AR and inadequate symptom control on nasal steroids or similar therapies.

Why it matters

Who can join: the full rules

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 presenting other active nasal comorbidities at screening (chronic rhinitis, drug-induced rhinitis, chronic rhinosinusitis with or without nasal polyps, severe nasal septal deviation, etc.) that may interfere with efficacy determination.
* Subjects with current or past history of infections of special concern (active tuberculosis, helminthic infections, severe herpes virus infections, etc.), or diagnosed with malignant tumors within 5 years before screening, excluding fully cured cervical carcinoma in situ and non-metastatic cutaneous squamous or basal cell carcinoma.
* Subjects with severe underlying medical conditions including severe hepatic and renal impairment, autoimmune diseases, cardiovascular and cerebrovascular disorders, HIV infection, active hepatitis B/C, immunosuppression, or history of solid organ/hematopoietic stem cell transplantation which, in the investigator's opinion, may pose safety risks via trial participation.
* Have a serious underlying medical condition that, in the opinion of the investigator, may pose a risk to subject safety by participation in a clinical trial.

Where it's running

• Beijing Tongren Hospital, CMU
  Beijing, Beijing Municipality, China Recruiting
• Beijing Children's Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting
• Beijing Friendship Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting
• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
  Beijing, Beijing Municipality, China Not yet recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Principal investigator: Luo Zhang — Beijing Tongren Hospital Affiliated to Capital Medical University
• Study coordinator: Qian Jia
• Email: clinicaltrial@keymedbio.com
• Phone: 028-88610620

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.