NCT07240376

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

Efficacy and Safety of Stapokibart (CM310) in Non-Allergic Rhinitis With Eosinophilia Syndrome (ESSNARES): An Investigator-initiated, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of this clinical trial is to evaluate the efficacy of Stapokibart (CM310) in alleviating nasal and ocular symptoms, as well as its safety profile, in adult patients with Non-Allergic Rhinitis with Eosinophilia Syndrome (NARES) who have shown a suboptimal response to intranasal corticosteroids. Adult NARES patients with an inadequate response to mometasone furoate nasal spray will be enrolled. While continuing treatment with intranasal mometasone furoate, patients will be randomized to receive either Stapokibart or a placebo. Over the 12-week treatment period and the subsequent 8-week follow-up period, the alleviation of nasal and ocular symptoms, the incidence of adverse events, and the results of safety assessments (such as physical examinations, electrocardiograms, complete blood counts, and blood biochemistry) will be evaluated. The final aim is to assess the efficacy and safety of Stapokibart in treating patients with NARES.

Conditions

• Non-Allergic Rhinitis With Eosinophilia Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-25
• Primary completion: 2026-12-31
• Completion: 2027-02-28
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

11 sites across 1 country: China