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Efficacy and Safety of Stapokibart in Non-Allergic Rhinitis With Eosinophilia Syndrome

NCT07240376 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-11-20

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if Stapokibart (CM310) works to treat Non-Allergic Rhinitis with Eosinophilia Syndrome (NARES) in adults. It will also learn about the safety of CM310.

The main questions it aims to answer are:

Does drug CM310 relieve the symptoms of participants? What medical problems do participants have when injecting CM310? Researchers will compare CM310 to a placebo (a look-alike substance that contains no drug) to see if CM310 works to treat NARES.

Participants will:

Inject CM310 or a placebo every 2 weeks for 12 weeks, and follow up for another 8 weeks.

Visit the clinic once every 2 weeks for checkups and tests. Keep a diary of their symptoms every day.

Conditions

  • Non-Allergic Rhinitis With Eosinophilia Syndrome

Interventions

BIOLOGICAL

Stapokibart (CM310)

Paticipants were given CM310 (with an initial dose of 600 mg followed by 300mg subcutaneous injection, once every two weeks) for 12 weeks. Follow up for another 8 weeks.During the treatment period, mometasone furoate was sprayed nasal every day

OTHER

Placebo

After enrollment, paticipants were given a placebo (subcutaneous injection, with the same dose as the experimental group, once every two weeks) for 12 weeks. Follow up for another 8 weeks. During the treatment period, mometasone furoate was sprayed nasal every day

Sponsors & Collaborators

  • Renmin Hospital of Wuhan University

    collaborator OTHER

  • Wuhan TongJi Hospital

    collaborator OTHER

  • Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Zheng Liu · Zhongnan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-25
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07240376 on ClinicalTrials.gov