NCT06171074

Brief Summary

This study is a multicenter, single arm phase II clinical study mainly evaluating the efficacy of CM310 in patients with seasonal allergic rhinitis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

December 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

December 4, 2023

Last Update Submit

December 6, 2023

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline mean of daily retrospective total nasal of symptom score (rTNSS)

    The total score of nasal symptoms (TNSS) is the sum of four symptom scores: runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3 points.

    Up to week 12

Study Arms (1)

CM310

EXPERIMENTAL

CM310, Subcutaneous injection

Biological: CM310

Interventions

CM310BIOLOGICAL

CM310 injection

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, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Luo Zhang

    Beijing Tong-Ren hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Jia

CONTACT

028-88610620qianjia@keymedbio.com

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

December 4, 2023

First Posted

December 14, 2023

Study Start

March 30, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations

CN(1)