Ongoing Clinical Trials for Chronic Rhinosinusitis with Nasal Polyps

There are currently 19 clinical trials underway worldwide studying new treatments for chronic rhinosinusitis with nasal polyps. These trials are testing various biologic medications that work by targeting specific proteins involved in inflammation, aiming to reduce the size of nasal polyps and improve symptoms such as nasal congestion, loss of smell, and breathing difficulties. The trials are being conducted across Europe, with studies taking place in countries including Austria, Belgium, Bulgaria, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain, and Sweden.

Clinical trial locations

Study of Tezepelumab effects on airway barrier function in patients with severe asthma, with or without chronic rhinosinusitis with nasal polyps

This Austrian trial is examining tezepelumab in patients with severe asthma who may or may not also have nasal polyps. The study focuses on understanding how this medication affects the protective barriers in both the upper and lower airways.

Main inclusion criteria: Adults aged 18-99 years must have a diagnosis of severe asthma and be receiving treatment at step 4 or 5. Participants must show evidence of uncontrolled disease through symptoms or recent need for oral corticosteroids, have lung function below 80% of predicted values, and show elevated markers of inflammation in blood or sputum samples. Those with nasal polyps must have this confirmed by examination or CT scan, and all participants must show evidence of mucus buildup in their airways.

Main exclusion criteria: The study excludes current smokers and those who quit within the past 6 months, people with recent respiratory infections, those who have used systemic steroids in the past month, and individuals with other chronic lung diseases besides asthma. People with uncontrolled high blood pressure, significant organ disease, recent cancer, or active autoimmune conditions cannot participate.

Focus and goals: The trial aims to understand how tezepelumab affects the protective barrier function of airways in patients with severe asthma. Researchers will examine how the airways respond to various irritating substances and study changes in cell composition and inflammatory markers over the treatment period.

Investigational drug: Tezepelumab is administered as a subcutaneous injection at doses up to 210 mg. The treatment period lasts up to 4 months, with a maximum total dose of 840 mg. This medication targets a specific protein called thymic stromal lymphopoietin that plays a role in airway inflammation.

Study on Dupilumab for Patients with Chronic Rhinosinusitis with Nasal Polyps and Eosinophilic Otitis Media

This Netherlands-based trial focuses on patients who have both nasal polyps and a specific type of ear inflammation called eosinophilic otitis media. The study evaluates how dupilumab affects ear symptoms and hearing function over time.

Main inclusion criteria: Patients must have both nasal polyps and eosinophilic otitis media. For the retrospective part, participants should have started dupilumab treatment from 2020 onwards with sufficient data from questionnaires completed at the start and after at least 6 or 12 months of treatment. For the prospective part, participants must be adults aged 18 or older who are starting dupilumab as part of their regular medical care.

Main exclusion criteria: Patients without both conditions cannot participate. The study does not involve vulnerable populations that might need special protection.

Focus and goals: The study monitors changes in ear symptoms and hearing function through regular assessments at 1, 3, 6, and 12 months. The primary focus is comparing symptoms between baseline and the 6 or 12-month timepoint. Participants complete otologic questionnaires and undergo audiometry testing and otoscopic examinations.

Investigational drug: Dupilumab is administered as a 300 mg subcutaneous injection using a pre-filled pen. It works by blocking proteins called interleukin-4 and interleukin-13, which are key drivers of allergic reactions and inflammation.

Study on How Mepolizumab Affects Patients with Chronic Rhinosinusitis with Nasal Polyps

This Netherlands trial investigates mepolizumab’s effects on patients with nasal polyps, aiming to identify biological markers that can predict treatment response and understand immune system reactions.

Main inclusion criteria: Adult patients (18 years or older) must have a diagnosis of nasal polyps with moderate or severe nasal symptoms. Participants need to show evidence of type 2 inflammation through specific blood or tissue tests. The study requires nasal endoscopy showing no significant abnormalities beyond the polyps.

Main exclusion criteria: Patients without the specific diagnosis, those outside the age range, and vulnerable populations are excluded from participation.

Focus and goals: The six-month study aims to identify biomarkers predicting response to mepolizumab and explore how cells react to the medication in laboratory settings. Researchers will collect information on symptom changes and immune system responses throughout the treatment period.

Investigational drug: Mepolizumab (Nucala 100 mg) is given as a subcutaneous injection using a pre-filled pen. The medication works by targeting and blocking interleukin-5, a protein that plays a key role in the inflammation process.

Study on Itepekimab for Adults with Chronic Rhinosinusitis and Nasal Polyps

This international trial across 10 European countries evaluates itepekimab’s effectiveness in reducing nasal polyp size and relieving nasal congestion over a 52-week period.

Main inclusion criteria: Participants must be 18 years or older with at least a one-year history of nasal polyps. They need either previous sinus surgery or worsening symptoms requiring systemic corticosteroids within the past year. A nasal polyp score of at least 5 out of 8 is required, with ongoing moderate to severe symptoms for at least 12 weeks, including nasal congestion and either loss of smell or runny nose. Female participants must use highly effective contraception during the study and for 20 weeks after the last dose.

Main exclusion criteria: Patients must be within the specified age range and willing to follow study procedures. Those with other interfering medical conditions, pregnancy, breastfeeding, current participation in another trial, recent or planned surgery, or history of certain allergic reactions are excluded.

Focus and goals: The study compares itepekimab to placebo over 52 weeks, monitoring changes in nasal polyp size, nasal congestion, sense of smell, and sinus opacification through regular assessments including CT scans.

Investigational drug: Itepekimab is a subcutaneous injection targeting interleukin-33, a protein involved in inflammation. Regular injections are given according to the study protocol to potentially shrink nasal polyps and relieve congestion.

Study on Itepekimab for Adults with Chronic Rhinosinusitis and Nasal Polyps

This study across 11 European countries tests itepekimab against placebo over 52 weeks, evaluating its effectiveness in reducing symptoms and improving quality of life for patients with poorly controlled nasal polyps.

Main inclusion criteria: Adults 18 years and older must have a one-year history of nasal polyps with either previous sinus surgery or recent need for systemic corticosteroids. A nasal polyp score of at least 5 out of 8 is required, with moderate to severe nasal blockage and additional symptoms like loss of smell or runny nose persisting for at least 12 weeks. Female participants must use effective birth control during and for 20 weeks after the study.

Main exclusion criteria: Those without the qualifying diagnosis, outside the age range, or part of vulnerable populations cannot participate.

Focus and goals: The double-blind study randomly assigns participants to receive either itepekimab or placebo as weekly injections for 52 weeks. Regular assessments monitor nasal polyp size, congestion levels, and quality of life through questionnaires and physical examinations.

Investigational drug: Itepekimab is given as a solution for injection using a pre-filled syringe. This monoclonal antibody targets interleukin-33 to reduce inflammation and potentially improve breathing and quality of life.

Study on Lebrikizumab for Adults with Chronic Rhinosinusitis and Nasal Polyps Using Intranasal Corticosteroids

This 10-country European trial tests lebrikizumab alongside continued use of intranasal corticosteroid sprays over 24 weeks, comparing it to placebo treatment.

Main inclusion criteria: Patients must have doctor-diagnosed nasal polyps on both sides with either recent systemic corticosteroid treatment, medical reasons preventing such treatment, or previous polyp surgery. A nasal polyp score of at least 5 out of 8 is required, with ongoing moderate or severe nasal congestion and either loss of smell or runny nose for at least 8 weeks. Those with asthma must have stable disease for 3 months before joining.

Main exclusion criteria: People with severe allergic reactions to study medications, current participation in another trial, recent nasal polyp surgery (within 6 months), uncontrolled infections, pregnancy, breastfeeding, recent cancer (within 5 years except certain skin cancers), or significant medical conditions affecting safety are excluded.

Focus and goals: The study evaluates how well lebrikizumab reduces nasal congestion and polyp size when added to regular nasal steroid sprays. Participants report daily symptoms in an electronic diary and undergo regular nasal endoscopy assessments.

Investigational drug: Lebrikizumab is administered as a subcutaneous injection while participants continue their intranasal corticosteroid sprays. The medication works by targeting and inhibiting interleukin-13, a protein involved in inflammatory responses.

Study on Mepolizumab and Nasal Polypectomy for Patients with Chronic Rhinosinusitis

This Spanish study compares treatment outcomes between mepolizumab alone and mepolizumab combined with a surgical procedure called nasal polypectomy to remove polyps.

Main inclusion criteria: Participants must be 18 years or older with a diagnosis of nasal polyps meeting specific criteria including two or more symptoms lasting at least 12 weeks. Eligibility for biologic treatment requires bilateral polyps and at least three of the following: evidence of type 2 inflammation, need for or contraindication to systemic corticosteroids, significantly impaired quality of life, significant smell loss, or comorbid asthma. A blood eosinophil count of 300 cells/µL or higher is required for certain patient groups.

Main exclusion criteria: Patients without the qualifying diagnosis, outside the specified age range, or part of vulnerable populations are excluded.

Focus and goals: The study evaluates whether combining surgery with mepolizumab leads to faster disease control compared to medication alone. Regular monitoring includes SNOT-22 questionnaire scores, visual analog scales for symptoms, and nasal examinations to assess treatment effectiveness over time.

Investigational drug: Mepolizumab (100 mg) is given as a subcutaneous injection using a pre-filled syringe. The medication targets interleukin-5 to reduce inflammation and decrease polyp size, potentially improving breathing and quality of life.

Study on Reducing Biologic Treatments Mepolizumab and Dupilumab for Patients with Severe Chronic Rhinosinusitis with Nasal Polyps

This Danish trial investigates whether patients with stable, partly controlled symptoms can maintain symptom control with less frequent dosing of mepolizumab or dupilumab.

Main inclusion criteria: Patients must be at least 18 years old and currently receiving dupilumab 300 mg or mepolizumab 100 mg every four weeks, with this treatment stable for at least three months. The condition must have been partly controlled or controlled for at least one year during treatment. Partly controlled means experiencing 1-2 specific symptoms like nasal blockage, runny nose, facial pain, impaired smell, sleep disturbance, diseased tissue on examination, or needing rescue treatment at least once.

Main exclusion criteria: Patients not treated with the specified medications for at least 18 months, without partly controlled disease for at least 12 months, outside the age range of 18-65, or part of vulnerable populations cannot participate.

Focus and goals: Over 52 weeks, the study gradually extends dosing intervals to evaluate how many patients maintain partly controlled disease with less frequent medication. Regular monitoring assesses symptoms and disease control throughout the tapering process.

Investigational drugs: Mepolizumab and dupilumab are both administered as subcutaneous injections. Mepolizumab blocks interleukin-5, while dupilumab blocks interleukin-4 and interleukin-13, all proteins involved in inflammation.

Study on Stopping Mepolizumab or Dupilumab in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps After 12 Months Symptom-Free

This Danish study examines whether patients who have been symptom-free for at least 12 months can safely stop their biologic treatment without symptom recurrence.

Main inclusion criteria: Patients must have had bilateral polyps, previous endoscopic sinus surgery, and meet at least three specific criteria including type 2 inflammation evidence, need for systemic corticosteroids or contraindication, SNOT-22 score of 40 or above, significant smell loss, or asthma requiring regular inhaled corticosteroids. They must be over 18, currently receiving stable treatment with dupilumab 300 mg or mepolizumab 100 mg every four weeks for at least three months, have considered their condition controlled throughout the past year with symptom scores of 5 or below, and show minimal polyps on examination with no need for surgery or rescue treatment during that year.

Main exclusion criteria: No specific exclusion reasons are listed.

Focus and goals: The study monitors patients after discontinuing treatment to determine what percentage can maintain complete remission and whether outcomes differ based on which medication was used.

Investigational drugs: Both mepolizumab and dupilumab are given as subcutaneous injections. These monoclonal antibodies target different inflammatory pathways to reduce polyp size and improve symptoms.

Study on Symptom Changes in Adults with Chronic Rhinosinusitis with Nasal Polyps Using Tezepelumab

This 7-country European trial observes symptom changes over 24 weeks in patients receiving tezepelumab, with participants keeping symptom diaries throughout the study.

Main inclusion criteria: Participants must be 18 years or older with a doctor’s diagnosis of nasal polyposis for at least 12 months. They need severe enough disease to potentially require surgery, with a total nasal polyp score of 4 or more, a mean nasal congestion score of 2 or more in the two weeks before visit 2, and ongoing symptoms for more than 8 weeks including runny nose, reduced or lost smell, and poor sleep quality. A SNOT-22 score of 30 or more is required, along with stable treatment including intranasal corticosteroids for at least 30 days. Body weight must be 40 kg or more, and participants must have either recent systemic corticosteroid treatment or history of nasal polyp surgery.

Main exclusion criteria: Those without qualifying diagnosis, outside the age range, unwilling to follow procedures, with interfering medical conditions, pregnant, breastfeeding, in another trial, with recent or planned surgery, severe allergic reactions, or unable to provide informed consent are excluded.

Focus and goals: Regular assessments over 24 weeks monitor changes in nasal congestion and other sinus-related symptoms through patient diaries and clinical evaluations.

Investigational drug: Tezepelumab is given as a 210 mg subcutaneous injection using a pre-filled syringe. This monoclonal antibody blocks a protein involved in inflammation to reduce polyp-related symptoms and improve quality of life.

Summary

The 19 ongoing clinical trials for chronic rhinosinusitis with nasal polyps reveal a concentrated research effort across Europe, with particularly strong activity in Poland (8 trials), Germany (5 trials), Italy (5 trials), Hungary (5 trials), and Belgium (5 trials). Denmark stands out with 6 trials, including several unique studies examining treatment optimization strategies.

The research landscape shows clear focus on biologic medications targeting different inflammatory pathways. Itepekimab appears in two large international trials spanning multiple countries, while dupilumab and mepolizumab are being studied not only for their primary effects but also for treatment de-escalation strategies in Danish trials. Several newer medications are being investigated, including tezepelumab, lebrikizumab, lunsekimig, benralizumab, secukinumab, and verekitug.

Most trials focus on adults aged 18 and older with moderate to severe disease who have either failed previous treatments or undergone surgery. Common inclusion criteria across studies include nasal polyp scores, symptom severity measurements, and evidence of type 2 inflammation. Treatment durations typically range from 16 to 52 weeks, with medications administered as subcutaneous injections.

The Danish studies are particularly noteworthy for exploring practical questions about long-term treatment management, including whether dosing can be reduced in stable patients and whether treatment can be safely stopped after prolonged symptom control. Other trials examine combination approaches, such as surgery plus medication, or treatment of patients with related conditions like asthma or ear inflammation.

These trials collectively represent efforts to expand treatment options, optimize existing therapies, and identify which patients will benefit most from specific medications, potentially leading to more personalized care approaches for this challenging condition.

#1 Clinical Trials Search in Europe

Chronic rhinosinusitis with nasal polyps – Trials in Disease

Ongoing Clinical Trials for Chronic Rhinosinusitis with Nasal Polyps

Clinical trial locations

Study of Tezepelumab effects on airway barrier function in patients with severe asthma, with or without chronic rhinosinusitis with nasal polyps

Study on Dupilumab for Patients with Chronic Rhinosinusitis with Nasal Polyps and Eosinophilic Otitis Media

Study on How Mepolizumab Affects Patients with Chronic Rhinosinusitis with Nasal Polyps

Study on Itepekimab for Adults with Chronic Rhinosinusitis and Nasal Polyps

Study on Itepekimab for Adults with Chronic Rhinosinusitis and Nasal Polyps

Study on Lebrikizumab for Adults with Chronic Rhinosinusitis and Nasal Polyps Using Intranasal Corticosteroids

Study on Mepolizumab and Nasal Polypectomy for Patients with Chronic Rhinosinusitis

Study on Reducing Biologic Treatments Mepolizumab and Dupilumab for Patients with Severe Chronic Rhinosinusitis with Nasal Polyps

Study on Stopping Mepolizumab or Dupilumab in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps After 12 Months Symptom-Free

Study on Symptom Changes in Adults with Chronic Rhinosinusitis with Nasal Polyps Using Tezepelumab

Summary

Ongoing Clinical Trials on Chronic rhinosinusitis with nasal polyps

Study on How Mepolizumab Affects Patients with Chronic Rhinosinusitis with Nasal Polyps

Study on Reducing Biologic Treatments Mepolizumab and Dupilumab for Patients with Severe Chronic Rhinosinusitis with Nasal Polyps

Study on Symptom Changes in Adults with Chronic Rhinosinusitis with Nasal Polyps Using Tezepelumab

Study of Tezepelumab effects on airway barrier function in patients with severe asthma, with or without chronic rhinosinusitis with nasal polyps

Study on Lebrikizumab for Adults with Chronic Rhinosinusitis and Nasal Polyps Using Intranasal Corticosteroids

Study on Dupilumab for Patients with Chronic Rhinosinusitis with Nasal Polyps and Eosinophilic Otitis Media

Study on Mepolizumab and Surgery for Patients with Chronic Rhinosinusitis with Nasal Polyps

Study on Mepolizumab and Nasal Polypectomy for Patients with Chronic Rhinosinusitis

Long‑term safety and tolerability of itepekimab in adults with inadequately controlled chronic rhinosinusitis with nasal polyps: an extension study

Comparison of dupilumab and tezepelumab for the treatment of chronic rhinosinusitis with nasal polyps.

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Chronic rhinosinusitis with nasal polyps – Trials in Disease

Ongoing Clinical Trials for Chronic Rhinosinusitis with Nasal Polyps

Clinical trial locations

Summary

Ongoing Clinical Trials on Chronic rhinosinusitis with nasal polyps

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