A Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis

NCT05470647 | Completed Phase 2

• 1 other identifier: CM310_IIS_SAR05
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period.

  Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period. The Total Nasal Symptom Score (TNSS) is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3.

  up to week 2

Study Arms (3)

Interleukin-4 receptor responders 1

EXPERIMENTAL

Interleukin-4 receptor was injected subcutaneously, once every two weeks.

Biological: Interleukin-4 receptor responders 1

Interleukin-4 receptor responders 2

EXPERIMENTAL

Interleukin-4 receptor was injected subcutaneously, once a week.

Biological: Interleukin-4 receptor responders 2

Controls

PLACEBO COMPARATOR

Placebo was injected subcutaneously.

Biological: Placebo

Interventions

Interleukin-4 receptor responders 1 BIOLOGICAL

Interleukin-4 receptor was injected subcutaneously.

Interleukin-4 receptor responders 1

Interleukin-4 receptor responders 2 BIOLOGICAL

Interleukin-4 receptor was injected subcutaneously.

Interleukin-4 receptor responders 2

Placebo BIOLOGICAL

Placebo was injected subcutaneously.

Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form.

You may not qualify if:

• Have any condition that are not suitable for participating in this study.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (1)

• Zhang Y, Yan B, Zhu Z, Wang X, Song X, Zhu D, Ma T, Zhang Y, Meng C, Wang G, Wang C, Zhang L. Efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial. EClinicalMedicine. 2024 Feb 6;69:102467. doi: 10.1016/j.eclinm.2024.102467. eCollection 2024 Mar.

  PMID: 38356731 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Luo zhang

  Beijing Tongren Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 22, 2022
• Study Start: August 17, 2022
• Primary Completion: September 24, 2022
• Study Completion: December 28, 2022
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

CN (1)