NCT05186909

Brief Summary

This study is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM310 in subjects with moderate to severe asthma. The study consists of three periods, including an up to 4-week screening period, a 24-week randomized treatment period, and a 8-week safety follow-up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2 asthma

Timeline
Completed

Started Jan 2022

Typical duration for phase_2 asthma

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

December 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

January 12, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2023

Completed
Last Updated

February 28, 2024

Status Verified

December 1, 2021

Enrollment Period

1.7 years

First QC Date

December 9, 2021

Last Update Submit

February 27, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks.

    Absolute change from baseline in pre-bronchodilator FEV1 in each dose group at 12 weeks of CM310 treatment compared with placebo.

    12 weeks

Secondary Outcomes (19)

  • Change from baseline in pre-bronchodilator FEV1 at each evaluation time point.

    24 weeks

  • Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point.

    24 weeks

  • Annualized rate of subjects experiencing severe asthma exacerbations.

    24 weeks

  • Time to the first onset of the severe asthma exacerbation event.

    24 weeks

  • Annualized rate of subjects experiencing the event of loss of asthma control (LOAC).

    24 weeks

  • +14 more secondary outcomes

Study Arms (3)

CM310 300mg Q2W

EXPERIMENTAL

CM310 is injected subcutaneously (SC) with a loading dose of 600 mg at the first dose, and then 300 mg each time, once every 2 weeks (Q2W) for a total of 12 doses.

Drug: CM310

CM310 150mg Q2W

EXPERIMENTAL

CM310 is injected subcutaneously (SC) with a loading dose of 300 mg at the first dose, and then 150 mg each time, once every 2 weeks (Q2W) for a total of 12 doses.

Drug: CM310

Placebo

PLACEBO COMPARATOR

Subcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 12 doses.

Other: Placebo

Interventions

CM310DRUG

CM310 Recombinant Humanized Monoclonal Antibody Injection

CM310 150mg Q2WCM310 300mg Q2W
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects are able to understand the nature of the study and voluntarily sign the ICF.
  • Diagnosed with asthma according to the 2021 version of the GINA guidelines for at least 1 year.
  • Pre-bronchodilator FEV1 measurement ≤ 80% of predicted normal value.
  • Subjects must have experienced a severe asthma exacerbation within 12 months prior to screening, and have not experienced a severe asthma exacerbation within 1 month prior to screening.

You may not qualify if:

  • Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.
  • Received biologics with the same therapeutic purpose within 6 months prior to screening, such as similar IL-4Rα antagonist, IL-5/5R, anti-IgE monoclonal antibody (mAb).
  • Diagnosed with chronic obstructive pulmonary disease (COPD) or other lung disorders that may compromise lung function (including but not limited to idiopathic pulmonary fibrosis, allergic granulomatous angiitis, bronchopulmonary aspergillosis allergic, pulmonary tuberculosis, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

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
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

January 11, 2022

Study Start

January 12, 2022

Primary Completion

September 13, 2023

Study Completion

September 13, 2023

Last Updated

February 28, 2024

Record last verified: 2021-12

Locations

CN(1)