NCT05428410|UnknownDMC
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Sponsor study identifier
observational
56
1 country
1
Study Start
June 17, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 17, 2022
Actual (reported)June 17, 2022
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June 23, 2022
Actual (reported)June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Base line sirius red staining and immunopathological staining
Base line sirius red staining and immunopathological staining
Base line
End point sirius red staining and immunopathological staining
End point sirius red staining and immunopathological staining
at Week 16
IL-4R was injected subcutaneously. Base line and treatment end point nasal polyp score were compared and NPS \>1.
IL-4R was injected subcutaneously. Base line and treatment end point nasal polyp score were compared and NPS ≤1.
Placebo was injected subcutaneously.
IL-4R was injected subcutaneously.
Placebo was injected subcutaneously.
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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.
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000, China
Polyps of chronic rhino-sinusitis with polyps
Luo Zhang
Beijing Tongren Hospital
First Submitted
June 17, 2022
First Posted
June 23, 2022
Study Start
June 17, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 1, 2023
Estimated (date passed)Molecular Markers in Predicting Response to Treatment in FH-deficient RCC Patients
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 23, 2022
Record last verified: 2022-05
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