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Study on the Treatment of Adolescent Patients With Seasonal Allergic Rhinitis

1. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

136

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina
        • Har ikke rekruttert ennå
        • Peking University Third Hospital
        • Ta kontakt med:
      • Beijing, Beijing Municipality, Kina
        • Har ikke rekruttert ennå
        • Beijing Friendship Hospital, Capital Medical University
        • Ta kontakt med:
      • Beijing, Beijing Municipality, Kina
        • Har ikke rekruttert ennå
        • China-Japan Friendship Hospital
        • Ta kontakt med:
      • Beijing, Beijing Municipality, Kina
        • Har ikke rekruttert ennå
        • Beijing Children's Hospital, Capital Medical University
        • Ta kontakt med:
      • Beijing, Beijing Municipality, Kina
      • Beijing, Beijing Municipality, Kina
        • Har ikke rekruttert ennå
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
        • Ta kontakt med:
      • Langfang, Beijing Municipality, Kina
        • Har ikke rekruttert ennå
        • Hebei Petroleum Central Hospital
        • Ta kontakt med:
    • Hebei
      • Baoding, Hebei, Kina
        • Har ikke rekruttert ennå
        • Affiliated Hospital of Hebei University
        • Ta kontakt med:
      • Cangzhou, Hebei, Kina
        • Har ikke rekruttert ennå
        • Cangzhou Central Hospital
        • Ta kontakt med:
      • Shijiazhuang, Hebei, Kina
        • Har ikke rekruttert ennå
        • Hebei General Hospital
        • Ta kontakt med:
      • Shijiazhuang, Hebei, Kina
        • Har ikke rekruttert ennå
        • The First Hospital of Hebei Medical University
        • Ta kontakt med:
      • Shijiazhuang, Hebei, Kina
        • Har ikke rekruttert ennå
        • Hebei Provincial Hospital of Traditional Chinese Medicine
        • Ta kontakt med:
      • Zhangjiakou, Hebei, Kina
        • Har ikke rekruttert ennå
        • First Affiliated Hospital of Hebei North University
        • Ta kontakt med:
    • Henan
      • Zhengzhou, Henan, Kina
        • Har ikke rekruttert ennå
        • The First Affiliated Hospital of Zhengzhou University
        • Ta kontakt med:
    • Inner Mongolia
      • Baotou, Inner Mongolia, Kina
        • Har ikke rekruttert ennå
        • Baotou Central Hospital
        • Ta kontakt med:
      • Hohhot, Inner Mongolia, Kina
        • Har ikke rekruttert ennå
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Ta kontakt med:
    • Jilin
      • Changchun, Jilin, Kina
        • Har ikke rekruttert ennå
        • China-Japan Union Hospital of Jilin University
        • Ta kontakt med:
    • Liaoning
      • Shenyang, Liaoning, Kina
        • Har ikke rekruttert ennå
        • Shengjing Hospital of China Medical University
        • Ta kontakt med:
    • Ningxia
      • Yinchuan, Ningxia, Kina
        • Har ikke rekruttert ennå
        • Yinchuan First People's Hospital
        • Ta kontakt med:
    • Shandong
      • Jinan, Shandong, Kina
        • Har ikke rekruttert ennå
        • Shandong Second Provincial General Hospital
        • Ta kontakt med:
      • Yantai, Shandong, Kina
        • Har ikke rekruttert ennå
        • Yantai Yuhuangding Hospital
        • Ta kontakt med:
      • Zibo, Shandong, Kina
        • Har ikke rekruttert ennå
        • Zibo central Hospital
        • Ta kontakt med:
    • Shanxi
      • Taiyuan, Shanxi, Kina
        • Har ikke rekruttert ennå
        • Shanxi Bethune Hospital
        • Ta kontakt med:
      • Taiyuan, Shanxi, Kina
        • Har ikke rekruttert ennå
        • The Second Hospital of Shanxi Medical University
        • Ta kontakt med:
      • Taiyuan, Shanxi, Kina
        • Har ikke rekruttert ennå
        • The First Hospital of Shanxi Medical University
        • Ta kontakt med:
      • Xi’an, Shanxi, Kina
        • Har ikke rekruttert ennå
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Ta kontakt med:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina
        • Har ikke rekruttert ennå
        • Tianjin First Central Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo gruppe
Legemiddel: Placebo
subkutan injeksjon
Eksperimentell: Stapokibart group
Biologisk: Stapokibart
subkutan injeksjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Endring og prosentvis endring fra baseline av human thymus og aktiveringsregulert kjemokin (TARC)
Tidsramme: Inntil uke 12
Samle blodprøvene for farmakodynamisk analyse
Inntil uke 12
endring og prosentvis endring fra baseline av antall og forhold mellom eosinofiler i blod
Tidsramme: Inntil uke 12
Samle blodprøvene for farmakodynamisk analyse
Inntil uke 12
Utviklingen av antistoff-antistoff (ADA) og nøytraliserende antistoff (Nab)
Tidsramme: Inntil uke 12
Samle blodprøvene for antistoff-antistofftesting
Inntil uke 12
Incidence of adverse events (AEs)
Tidsramme: Up to week 12
Evaluate the incidence of treatment-emergency adverse events.
Up to week 12
Serum Stapokibart concentration
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chengdu Kangnuoxing Biopharma,Inc.

Etterforskere

  • Hovedetterforsker: Luo Zhang, Beijing Tongren Hospital Affiliated to Capital Medical University
  • Hovedetterforsker: Chengshuo Wang, Beijing Tongren Hospital Affiliated to Capital Medical University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. august 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

25. juni 2026

Først innsendt som oppfylte QC-kriteriene

25. juni 2026

Først lagt ut (Faktiske)

1. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. september 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CM310-107208

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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