NCT05908721

Brief Summary

This study is a multicenter, single arm, open-label phase II clinical study mainly evaluating the safety of CM310 in patients with allergic rhinitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 23, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

November 8, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 8, 2023

Last Update Submit

November 7, 2024

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    Incidence (including number of patients, events and percentage) of adverse events.

    Week 12

Study Arms (1)

CM310

EXPERIMENTAL

Subcutaneous injection

Biological: CM310

Interventions

CM310BIOLOGICAL

IL-4Rα monoclonal antibody

CM310

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 18-65.
  • Understand the study and sign the Informed Consent Form voluntarily.
  • Take effective contraception measures throughout the study period.

You may not qualify if:

  • Used other investigational drugs.
  • Allergies to drugs with IL-4Rα monoclonal antibody or drug components of CM310.
  • Plan to participate in other studies during this clinical trial.
  • With malignant or benign tumors of the nasal cavity.
  • Other reasons the researcher believes that the subject is not suitable to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tong-Ren hospital

Beijing, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Luo Zhang

    Beijing Tong-Ren hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2023

First Posted

June 18, 2023

Study Start

August 23, 2023

Primary Completion

December 10, 2023

Study Completion

December 10, 2023

Last Updated

November 8, 2024

Record last verified: 2024-06

Locations

CN(1)