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

NCT05428410 | Unknown DMC

• 1 other identifier: TR-CM310 treatment biomarker
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Rhino-sinusitis; IL-4R; Monoclonal Antibody; Biomarker

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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 nonresponders

IL-4R was injected subcutaneously. Base line and treatment end point nasal polyp score were compared and NPS ≤1.

Other: IL-4R

Controls

Placebo was injected subcutaneously.

Other: Placebo

Interventions

IL-4R OTHER

IL-4R was injected subcutaneously.

IL-4R nonresponders; IL-4R responders

Placebo OTHER

Placebo was injected subcutaneously.

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients enrolled in NCT04805398.

You may not qualify if:

• Patients not enrolled in NCT04805398.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Polyps of chronic rhino-sinusitis with polyps

Study Officials

• Luo Zhang

  Beijing Tongren Hospital

  STUDY CHAIR

Central Study Contacts

Luo Zhang

CONTACT

+86-13910830399; dr.luozhang@139.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: June 17, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 23, 2022

Record last verified: 2022-05

Locations

CN (1)