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Study on the Treatment of Adolescent Patients With Seasonal Allergic Rhinitis

1 septembre 2026 mis à jour par: Chengdu Kangnuoxing Biopharma,Inc.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Stapokibart Injection in Adolescent Patients With Seasonal Allergic Rhinitis Receiving Background Therapy

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.

All participants will receive standard of care treatment as concomitant medications. Stapokibart or placebo will be administered as add-on therapy.

Type d'étude

Interventionnel

Inscription (Estimé)

136

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine
        • Pas encore de recrutement
        • Peking University Third Hospital
        • Contact:
      • Beijing, Beijing Municipality, Chine
        • Pas encore de recrutement
        • Beijing Friendship hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing Municipality, Chine
        • Pas encore de recrutement
        • China-Japan Friendship Hospital
        • Contact:
      • Beijing, Beijing Municipality, Chine
        • Pas encore de recrutement
        • Beijing Children's Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing Municipality, Chine
      • Beijing, Beijing Municipality, Chine
        • Pas encore de recrutement
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
        • Contact:
      • Langfang, Beijing Municipality, Chine
        • Pas encore de recrutement
        • Hebei Petroleum Central Hospital
        • Contact:
    • Hebei
      • Baoding, Hebei, Chine
        • Pas encore de recrutement
        • Affiliated Hospital of Hebei University
        • Contact:
      • Cangzhou, Hebei, Chine
        • Pas encore de recrutement
        • Cangzhou Central Hospital
        • Contact:
      • Shijiazhuang, Hebei, Chine
        • Pas encore de recrutement
        • Hebei General Hospital
        • Contact:
      • Shijiazhuang, Hebei, Chine
        • Pas encore de recrutement
        • The First Hospital of Hebei Medical University
        • Contact:
      • Shijiazhuang, Hebei, Chine
        • Pas encore de recrutement
        • Hebei Provincial Hospital of Traditional Chinese Medicine
        • Contact:
      • Zhangjiakou, Hebei, Chine
        • Pas encore de recrutement
        • First Affiliated Hospital of Hebei North University
        • Contact:
    • Henan
      • Zhengzhou, Henan, Chine
        • Pas encore de recrutement
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, Chine
        • Pas encore de recrutement
        • Baotou Central Hospital
        • Contact:
      • Hohhot, Inner Mongolia, Chine
        • Pas encore de recrutement
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
    • Jilin
      • Changchun, Jilin, Chine
        • Pas encore de recrutement
        • China-Japan Union Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, Chine
        • Pas encore de recrutement
        • Shengjing Hospital of China Medical University
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, Chine
        • Pas encore de recrutement
        • Yinchuan First People's Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, Chine
        • Pas encore de recrutement
        • Shandong Second Provincial General Hospital
        • Contact:
      • Yantai, Shandong, Chine
        • Pas encore de recrutement
        • Yantai YuHuangDing Hospital
        • Contact:
      • Zibo, Shandong, Chine
        • Pas encore de recrutement
        • Zibo Central Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, Chine
        • Pas encore de recrutement
        • Shanxi Bethune Hospital
        • Contact:
      • Taiyuan, Shanxi, Chine
        • Pas encore de recrutement
        • The Second Hospital of Shanxi Medical University
        • Contact:
      • Taiyuan, Shanxi, Chine
        • Pas encore de recrutement
        • The First Hospital of Shanxi Medical University
        • Contact:
      • Xi’an, Shanxi, Chine
        • Pas encore de recrutement
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Chine
        • Pas encore de recrutement
        • Tianjin First Central Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Groupe placebo
Médicament: Placebo
injection sous-cutanée
Expérimental: Stapokibart group
Biologique: Stapokibart
injection sous-cutanée

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment
Délai: Up to week 4
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Up to week 4

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changement et pourcentage de changement par rapport à la valeur initiale du thymus humain et de la chimiokine régulée par activation (TARC)
Délai: Jusqu'à la semaine 12
Recueillir les échantillons de sang pour l'analyse pharmacodynamique
Jusqu'à la semaine 12
changement et pourcentage de changement par rapport à la valeur initiale du nombre et des ratios d'éosinophiles dans le sang
Délai: Jusqu'à la semaine 12
Recueillir les échantillons de sang pour l'analyse pharmacodynamique
Jusqu'à la semaine 12
Le développement d’anticorps anti-médicament (ADA) et d’anticorps neutralisants (Nab)
Délai: Jusqu'à la semaine 12
Recueillir les échantillons de sang pour les tests d'anticorps anti-médicament
Jusqu'à la semaine 12
Incidence of adverse events (AEs)
Délai: Up to week 12
Evaluate the incidence of treatment-emergency adverse events.
Up to week 12
Serum Stapokibart concentration
Délai: Up to week 12
Collect the blood samples for Pharmacokinetics analysis
Up to week 12
change and percent change from baseline of total immunoglobulin E (IgE)
Délai: Up to week 12
Collect the blood samples for Pharmacodynamics analysis
Up to week 12
Mean change from baseline in daily rTNSS over 4 weeks of treatment
Délai: Up to week 4
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Up to week 4
Mean change from baseline in the daily AM and PM reflective total nasal symptom score (AM and PM rTNSS) over 2 and 4 weeks of treatment
Délai: Up to week 4
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Up to week 4
Mean change and mean percent change from baseline in daily AM pre-dose instantaneous total nasal symptom score (iTNSS) over 2 weeks and 4 weeks of treatment
Délai: Up to week 4
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Up to week 4
Mean percent change from baseline in daily rTNSS over 2 and 4 weeks of treatment
Délai: Up to week 4
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Up to week 4
Mean change from baseline in daily rTNSS (including AM rTNSS and PM rTNSS) for individual nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) over 2 and 4 weeks of treatment
Délai: Up to week 4
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Up to week 4
Mean change and mean percent change from baseline in daily reflective total ocular symptom score (rTOSS) over 2 weeks or 4 weeks of treatment
Délai: Up to week 4
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Up to week 4
Mean change from baseline in daily AM and PM reflective total ocular symptom score (AM and PM rTOSS) over 2 weeks and 4 weeks of treatment
Délai: Up to week 4
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Up to week 4
Mean change from baseline in daily AM pre-dose instantaneous total ocular symptom score (iTOSS) over 2 weeks and 4 weeks of treatment
Délai: Up to week 4
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Up to week 4
Mean percent change from baseline in daily rTOSS over 2 weeks and 4 weeks of treatment
Délai: Up to week 4
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Up to week 4
Mean percent change from baseline in daily AM pre-dose iTOSS over 2 weeks and 4 weeks of treatment
Délai: Up to week 4
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Up to week 4
Mean change from baseline in daily rTOSS (including AM and PM rTOSS) for individual symptoms (itching/burning eyes, tearing/watering eyes, and eye redness) over 2 weeks and 4 weeks of treatment
Délai: Up to week 4
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.With higher scores indicating a greater impact on quality of life.
Up to week 4
The change from baseline in rhinoconjunctivitis quality of life questionnaire (RQLQ(S)≥12) score in allergic rhinitis participants over 2 weeks and 4 weeks of treatment
Délai: Up to week 4
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)≥12) is a 28-item, self-administered, disease-specific (AR) quality of life scale used by participants to assess quality of life over a week.Each question is scored from 0 to 6, with higher scores indicating a greater impact on quality of life.
Up to week 4

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Chengdu Kangnuoxing Biopharma,Inc.

Les enquêteurs

  • Chercheur principal: Luo Zhang, Beijing Tongren Hospital affiliated to Capital Medical University
  • Chercheur principal: Chengshuo Wang, Beijing Tongren Hospital affiliated to Capital Medical University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 août 2026

Achèvement primaire (Estimé)

1 décembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

25 juin 2026

Première soumission répondant aux critères de contrôle qualité

25 juin 2026

Première publication (Réel)

1 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 septembre 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CM310-107208

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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