Study on Biomarkers to Predict the Efficacy of IL-4R Monoclonal Antibody for Chronic Rhino-sinusitis With Polyps

June 17, 2022 updated by: Beijing Tongren Hospital

Study on Biomarkers to Predict the Efficacy of IL-4R Monoclonal Antibody（CM310） for Chronic Rhino-sinusitis With Polyps

The prevalence of chronic rhinosinusitis in China is about 8%, and some patients still suffer from recurrences after surgery and drug treatment. Monoclonal antibody is considered to be a new drug strategy that can significantly improve the control rate of such patients, but there is a lack of markers to guide the selection of monoclonal antibodies. The price of monoclonal antibody is expensive, which calls for screening markers for predicting the efficacy of monoclonal antibody and precisely implementing this treatment strategy. In addition, it can also improve the quality of life of patients and reduce the social and economic burden.

Beijing Tongren Hospital, Capital Medical University recently completed a randomized, double-blind, placebo-controlled, phase II clinical study which included multiple subcutaneous administration of CM310 recombinant humanized monoclonal antibody injection in patients with chronic sinusitis and nasal polyps to evaluate the efficacy and safety as well as the pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy(NCT04805398). The therapeutic target of CM310 recombinant humanized monoclonal antibody injection is IL-4R. The unblinded data showed significant differences in the efficacy of the subjects and we started the investigator-initiate trial (IIT) study aiming at investigating the remaining samples of the project and carrying out a biomarker study to screen and predict the efficacy of IL-4R monoclonal antibody.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The prevalence of chronic rhinosinusitis in China is about 8%, and some patients still suffer from recurrences after surgery and drug treatment. Monoclonal antibody is considered to be a new drug strategy that can significantly improve the control rate of such patients, but there is a lack of markers to guide the selection of monoclonal antibodies. The price of monoclonal antibody is expensive, which calls for screening markers for predicting the efficacy of monoclonal antibody and precisely implementing this treatment strategy. In addition, it can also improve the quality of life of patients and reduce the social and economic burden.

Beijing Tongren Hospital, Capital Medical University recently completed a randomized, double-blind, placebo-controlled, phase II clinical study which included multiple subcutaneous administration of CM310 recombinant humanized monoclonal antibody injection in patients with chronic sinusitis and nasal polyps to evaluate the efficacy and safety as well as the pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy(NCT04805398, detailed in https://clinicaltrials.gov/ct2/show/NCT04805398). The therapeutic target of CM310 recombinant humanized monoclonal antibody injection is IL-4R. The unblinded data showed significant differences in the efficacy of the subjects and we started the IIT study aiming at investigating the remaining samples of the project and carrying out a biomarker study to screen and predict the efficacy of IL-4R monoclonal antibody.

The biomarker levels between IL-4R responders(Defined as Nasal Polyps Score (NPS)>1 at 16 months after subcutaneously CM310) and IL-4R nonresponders (Defined as Nasal NPS≤1 at 16 months after subcutaneously CM310)were compared. The biomarker levels between IL-4R and control groups were also compared.

Study Type

Observational

Enrollment (Anticipated)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Beijing Tongren Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients wih Bilateral CRSwNP. Prior treatment with systemic corticosteroids (SCS), and/or contraindicate to or intolerance to SCS, and/or with prior surgery to nasal polyps.

Stable dose of intranasal corticosteroids for at least 4 weeks before screening. Ongoing symptoms for at least 4 weeks before screening as ptients enrolled in NCT04805398.

Description

Inclusion Criteria:

Patients enrolled in NCT04805398.

Exclusion Criteria:

Patients not enrolled in NCT04805398.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IL-4R responders
IL-4R was injected subcutaneously. Base line and treatment end point nasal polyp score were compared and NPS >1.
Other: IL-4R
IL-4R was injected subcutaneously.
IL-4R nonresponders
IL-4R was injected subcutaneously. Base line and treatment end point nasal polyp score were compared and NPS ≤1.
Other: IL-4R
IL-4R was injected subcutaneously.
Controls
Placebo was injected subcutaneously.
Other: Placebo
Placebo was injected subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Base line sirius red staining and immunopathological staining
Time Frame: Base line
Base line sirius red staining and immunopathological staining
Base line
End point sirius red staining and immunopathological staining
Time Frame: at Week 16
End point sirius red staining and immunopathological staining
at Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 17, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

June 17, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR-CM310 treatment biomarker

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

We haven't decided sharing the IPD yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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