Study on Biomarkers to Predict the Efficacy of IL-4R Monoclonal Antibody for Chronic Rhino-sinusitis With Polyps
NCT ID: NCT05428410
Last Updated: 2022-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
56 participants
OBSERVATIONAL
2022-06-17
2023-06-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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IL-4R responders
IL-4R was injected subcutaneously. Base line and treatment end point nasal polyp score were compared and NPS \>1.
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.
IL-4R
IL-4R was injected subcutaneously.
Controls
Placebo was injected subcutaneously.
Placebo
Placebo was injected subcutaneously.
Interventions
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IL-4R
IL-4R was injected subcutaneously.
Placebo
Placebo was injected subcutaneously.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Responsible Party
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Principal Investigators
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Luo Zhang
Role: STUDY_CHAIR
Beijing Tongren Hospital
Locations
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Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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TR-CM310 treatment biomarker
Identifier Type: -
Identifier Source: org_study_id
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