An observational study in Chronic Rhino-sinusitis, IL-4R and Monoclonal Antibody, sponsored by Beijing Tongren Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-23.
Sponsored by Beijing Tongren Hospital · Observational
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.
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.
415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.
This study's planned enrollment of 56 is below the median of 110 across 76 observational studies indexed under Sinusitis.
Browse Sinusitis studies →Beijing Tongren Hospital is the lead sponsor of 154 studies on the registry; 49 are open to participants now.
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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.
Patients enrolled in NCT04805398.
Exclusion Criteria:
Patients not enrolled in NCT04805398.
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. Base line and treatment end point nasal polyp score were compared and NPS ≤1.
Other: IL-4R
Placebo was injected subcutaneously.
Other: Placebo
IL-4R was injected subcutaneously.
Placebo was injected subcutaneously.
Base line sirius red staining and immunopathological staining
Base line sirius red staining and immunopathological staining
Time frame: Base line
End point sirius red staining and immunopathological staining
End point sirius red staining and immunopathological staining
Time frame: at Week 16
Plan to share: Undecided — We haven't decided sharing the IPD yet.
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Beijing Tongren Hospital