Study of Stapokibart Injection in Patients With Allergic Rhinitis

Last updated: November 7, 2024
Sponsor: Keymed Biosciences Co.Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Allergy (Pediatric)

Allergies & Asthma

Allergy

Treatment

Stapokibart Injection

Placebo

Clinical Study ID

NCT06525597
CM310-107101
  • Ages 12-65
  • All Genders

Study 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

Inclusion Criteria:

  • Able to understand the study and voluntarily sign the Informed consent form.

  • Diagnosed Allergic Rhinitis according to the Criteria stated in the ChineseGuidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, RevisedEdition).

  • Subjects with asthma must be evaluated by the researcher as having a stablecondition.

  • Has a positive skin prick test (SPT) or positive antigen-specific serumimmunoglobulin E (IgE).

Exclusion

Exclusion Criteria:

  • Use of anti-interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody,thymic stromal lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonalantibody, other monoclonal antibodies, or other biologics within 10 weeks or 5half-lives (whichever is longer) prior to the screening visit.

  • Use of any investigational product within 4 weeks prior to the screening visit orplanning to participate in other clinical studies during this study.

  • Forced expiratory volume in 1 second (FEV1) ≤ 50% of the predicted value during thescreening/run-in period.

  • Have acute sinusitis, nasal infection, or upper respiratory tract infection atscreening or within 2 weeks prior to screening.

  • Have received a live-attenuated vaccine within 12 weeks prior to randomization orplanning to receive one during the study.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Stapokibart Injection
Phase: 2
Study Start date:
September 30, 2024
Estimated Completion Date:
October 30, 2025

Study Description

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.

Connect with a study center

  • Beijing Tongren Hospital, CMU

    Beijing, Beijing
    China

    Active - Recruiting

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