Study of Stapokibart Injection in Patients With Allergic Rhinitis (MIZAR)

November 7, 2024 updated by: Keymed Biosciences Co.Ltd

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Patients With Allergic Rhinitis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Tongren Hospital, CMU
        • Contact:
          • Luo Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stapokibart Group
Stapokibart, subcutaneous, once every two weeks
Biological: Stapokibart Injection
IL-4Rα monoclonal antibody
Placebo Comparator: Placebo Group
Placebo, subcutaneous, once every two weeks
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 4 weeks of treatment.
Time Frame: 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.
Up to week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keymed Biosciences Co.Ltd

Investigators

  • Principal Investigator: Luo Zhang, Beijing Tong-Ren hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2024

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM310-107101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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