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NCT05428410
Study on Biomarkers to Predict the Efficacy of IL-4R Monoclonal Antibody for Chronic Rhino-sinusitis With Polyps
trial testing IL-4R in Chronic Rhino-sinusitis in 56 participants. Status unknown.
1 June 2023
Quick facts
| Lead sponsor | Beijing Tongren Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 56 |
| Start date | 17 June 2022 |
| Primary completion | 1 June 2023 |
| Estimated completion | 1 June 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- IL-4R
- Placebo
Conditions studied
- Chronic Rhino-sinusitis — all drugs for Chronic Rhino-sinusitis →
- IL-4R — all drugs for IL-4R →
- Monoclonal Antibody — all drugs for Monoclonal Antibody →
- Biomarker — all drugs for Biomarker →
Sponsor
Beijing Tongren Hospital
Who can join
18 and older, any sex, with Chronic Rhino-sinusitis or IL-4R. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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). 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05428410 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Tongren Hospital
- Last refreshed: 23 June 2022
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