A Cohort Study on Biomarkers to Predict the Efficacy of Biologics for Chronic Rhinosinusitis with Nasal Polyps

February 5, 2025 updated by: Beijing Tongren Hospital
Recently, several biologic therapies have become available for treating chronic rhinosinusitis with nasal polyps (CRSwNP). However, not every patient responds to these treatments. This clinical trial aims to develop a non-invasive predictive model to help determine how effective IL-4Rα targeted monoclonal antibody therapy will be for individuals with CRSwNP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Beijing Tongren Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-75 years old.
  2. With bilateral chronic rhinosinusitis with nasal polyposis.
  3. Nasal Polyp Score ≥4 (minimum score of 2 per nasal cavity) at baseline.
  4. Nasal congestion score ≥2 at baseline.
  5. Patients who have received systemic corticosteroids (SCS) treatment within 2 years before screening, and/or have contraindications or intolerance to SCS treatment, and/or received surgical for nasal polyps more than 6 months before screening.
  6. Have been using intranasal corticosteroids (INCS) at a stable dose for at least 4 weeks before screening.
  7. Symptoms of nasal obstruction and additional symptoms such as loss of smell or rhinorrhea should be present for at least 4 weeks before screening.
  8. Good adherence.

Exclusion Criteria:

  1. Not enough washing out period for prior biological therapy (within 10 weeks or 5 half-lives [whichever is longer] before baseline).
  2. Use of systemic immunosuppressants for inflammatory diseases or autoimmune diseases within 8 weeks or 5 half-lives before baseline (whichever is longer).
  3. Initiation of leukotriene receptor antagonist treatment, oral glucocorticoid treatment, or traditional Chinese medicine treatment for chronic rhinosinusitis within 4 weeks before baseline.
  4. Subjects who have undergone surgery that changed the nasal structure and cannot be evaluated for Nasal Polyp Score.
  5. Participants with a forced expiratory volume in 1 second (FEV1) ≤50% of predicted normal during screening/run-in period.
  6. Hypersensitivity to MFNS or anti-IL-4R monoclonal antibodies or stapokibart components.
  7. Concomitant with other poorly controlled serious diseases or recurrent chronic diseases.
  8. Women who are pregnant, breastfeeding, or planning either during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: therapy group
Stapokibart subcutaneously every two weeks plus mometasone furoate nasal spray 200 μg once daily
Biological: Stapokibart
Stapokibart subcutaneously every two weeks
Drug: Mometasone Furoate Nasal Spray (MFNS)
mometasone furoate nasal spray 200 μg once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nasal Polyps Score (NPS)
Time Frame: week 16
NPS score ranges from 0-8 (sum of 0-4 for each nasal), higher score means a worse outcome.
week 16
Nasal Congestion Score (NCS)
Time Frame: week 16
Change from baseline in the Nasal Congestion Score (NCS) at week 16. NCS score range from 0 to 3, with higher score means worse nasal symptom.
week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nasal Polyp Score (NPS)
Time Frame: Week 2，4，8，12，20，24，28，32，36，40
Changes from baseline in nasal polyp score (NPS) at each evaluation time point. NPS score ranges from 0-8 (sum of 0-4 for each nasal), higher score means a worse outcome.
Week 2，4，8，12，20，24，28，32，36，40
Nasal Congestion Score (NCS)
Time Frame: Week 2，4，8，12，20，24，28，32，36，40
Changes from baseline in nasal congestion score (NCS) at each evaluation time point. NCS score range from 0 to 3, with higher score means worse nasal symptom.
Week 2，4，8，12，20，24，28，32，36，40
sino-nasal outcome test-22 (SNOT-22)
Time Frame: Week 2，4，8，12，20，24，28，32，36，40
Changes from baseline in sino-nasal outcome test-22 (SNOT-22) score at each evaluation time point. The SNOT-22 score is the sum of the scores of 22 items, ranging from 0 to 110 (higher scores indicate worse outcomes).
Week 2，4，8，12，20，24，28，32，36，40
nasal total symptom score (TSS)
Time Frame: Week 2，4，8，12，20，24，28，32，36，40
Changes from baseline in nasal total symptom score (TSS) at each evaluation timepoint. The evaluation content of TSS includes three aspects: nasal congestion, loss of smell and running nose. Each aspect has a score of 0-3 with a total score of 0-9. The higher score indicates the more severe overall symptom.
Week 2，4，8，12，20，24，28，32，36，40
Asthma Control Questionnaire (ACQ-6)
Time Frame: Week 2，4，8，12，20，24，28，32，36，40
Changes from baseline in Asthma Control Questionnaire (ACQ-6) at each evaluation timepoint for participants with asthma. The ACQ-6 is a questionnaire used to evaluate the degree of asthma control. Each question is scored from 0 to 6 according to its severity. The higher the score, the less satisfactory symptom control is.
Week 2，4，8，12，20，24，28，32，36，40
Lund-Mackay CT score
Time Frame: week 16
Change from baseline in Lund-Mackay CT score evaluated by sinus computed tomography (CT) at each evaluation timepoint. The total Lund-Mackay score ranges from 0 to 24 points. The six parts of the nasal sinuses on both sides are evaluated separately. The higher the score, the more severe the CRS condition.
week 16
Pulmonary function test
Time Frame: week 16
Change from baseline in forced expiratory volume in 1 second (FEV1) at each evaluation timepoint for participants with asthma.
week 16
Change of NPS
Time Frame: Week 2，4，8，12，16
Proportion of participants with ≥1 point improvement from baseline in NPS at each evaluation timepoint. Proportion of participants with ≥2 point improvement from baseline in NPS at each evaluation timepoint.
Week 2，4，8，12，16
Change of NCS
Time Frame: Week 2，4，8，12，16
Proportion of participants with ≥1 point improvement from baseline in NCS at each evaluation timepoint. Proportion of participants with ≥2 point improvement from baseline in NCS at each evaluation timepoint.
Week 2，4，8，12，16
Pharmacodynamics
Time Frame: Week 4，8，12，16，20，24，28，32，36，40
Change from baseline in serum biomarker level (eosinophil level).
Week 4，8，12，16，20，24，28，32，36，40
Pharmacodynamics
Time Frame: week 16
Change from baseline of eosinophil level in nasal polyps biospy tissue.
week 16
The change of biomarkers
Time Frame: Week 8，16，24，32，40
Changes from baseline of expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes.
Week 8，16，24，32，40
Pulmonary function test
Time Frame: week 16
Change from baseline in forced vital capacity (FVC) at each evaluation timepoint for participants with asthma.
week 16
Pulmonary function test
Time Frame: week 16
Change from baseline in mean flow with forced expiratory volume of 25% ~ 75% vital capacity (FEF25 ~ 75%) at each evaluation timepoint for participants with asthma.
week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TR-Biological treatment of NP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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