Study of Stapokibart Injection in Patients With Allergic Rhinitis

Phase 2

Recruiting

• Conditions: Allergic Rhinitis
• Interventions: Biological: Stapokibart Injection; Drug: Placebo

• Registration Number: NCT06525597
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-29
• Status Verified: 2024-08
• Study Start: 2024-09-30
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Able to understand the study and voluntarily sign the Informed consent form.
• Diagnosed Allergic Rhinitis according to the Criteria stated in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition).
• Subjects with asthma must be evaluated by the researcher as having a stable condition.
• Has a positive skin prick test (SPT) or positive antigen-specific serum immunoglobulin E (IgE).

Exclusion Criteria

• Use of anti-interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody, thymic stromal lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonal antibody, other monoclonal antibodies, or other biologics within 10 weeks or 5 half-lives (whichever is longer) prior to the screening visit.
• Use of any investigational product within 4 weeks prior to the screening visit or planning to participate in other clinical studies during this study.
• Forced expiratory volume in 1 second (FEV1) ≤ 50% of the predicted value during the screening/run-in period.
• Have acute sinusitis, nasal infection, or upper respiratory tract infection at screening or within 2 weeks prior to screening.
• Have received a live-attenuated vaccine within 12 weeks prior to randomization or planning to receive one during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stapokibart Group	Stapokibart Injection	Stapokibart, subcutaneous, once every two weeks
Placebo Group	Placebo	Placebo, subcutaneous, once every two weeks

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 4 weeks of treatment.	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.

Trial Locations

Locations (1)

Beijing Tongren Hospital, CMU; 🇨🇳 Beijing, Beijing, China