Ongoing Clinical Trials for Eosinophilic Granulomatosis with Polyangiitis
Six clinical trials are currently investigating new treatments for eosinophilic granulomatosis with polyangiitis, a rare disease causing blood vessel inflammation. These studies are testing various medications including NS-229, mepolizumab, tezepelumab, benralizumab, and depemokimab across multiple European countries, offering patients opportunities to access innovative therapies while helping advance medical knowledge about this challenging condition.
Clinical trial locations
- Austria
- Belgium
- France
- Study on the Effectiveness and Safety of NS-229 for Patients with Eosinophilic Granulomatosis with Polyangiitis
- Study on Benralizumab and Mepolizumab for Patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA) Receiving Standard Care
- Study on Mepolizumab and Drug Combination for Patients with Eosinophilic Granulomatosis with Polyangiitis
- Study on the Effectiveness and Safety of Depemokimab vs. Mepolizumab for Adults with Relapsing or Refractory Eosinophilic Granulomatosis with Polyangiitis
- Germany
- Study on the Effectiveness and Safety of NS-229 for Patients with Eosinophilic Granulomatosis with Polyangiitis
- Study on Benralizumab and Mepolizumab for Patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA) Receiving Standard Care
- Study on the Effectiveness and Safety of Depemokimab vs. Mepolizumab for Adults with Relapsing or Refractory Eosinophilic Granulomatosis with Polyangiitis
- Hungary
- Italy
- Study on the Effectiveness and Safety of NS-229 for Patients with Eosinophilic Granulomatosis with Polyangiitis
- Study on the Effectiveness of Tezepelumab for Adults with Eosinophilic Granulomatosis with Polyangiitis (EGPA)
- Study on Benralizumab and Mepolizumab for Patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA) Receiving Standard Care
- Study on the Effectiveness and Safety of Depemokimab vs. Mepolizumab for Adults with Relapsing or Refractory Eosinophilic Granulomatosis with Polyangiitis
- Netherlands
- Poland
- Portugal
- Spain
- Sweden
Study on the Effectiveness and Safety of NS-229 for Patients with Eosinophilic Granulomatosis with Polyangiitis
This trial is testing NS-229, a Janus kinase 1 inhibitor taken as an oral tablet, for treating patients with this condition. The study runs for 28 weeks and compares NS-229 to a placebo.
Who can participate: Adults aged 18 or older with a confirmed diagnosis must have a disease activity score of 3 or more and be taking at least 7.5 mg of prednisone or prednisolone daily. The diagnosis should include a history of eosinophilia and at least two specific features such as certain types of inflammation shown on biopsy, nerve problems, lung issues, sinus problems, heart muscle disease, kidney inflammation, lung bleeding, skin rash, a positive ANCA test, or asthma. Women who can become pregnant and men with partners who can become pregnant must use reliable birth control.
Who cannot participate: Patients with conditions other than this disease, those outside the specified age range, those not meeting the clinical trial criteria, and individuals from vulnerable populations are excluded.
Study focus: The main goal is to evaluate how many participants achieve remission, meaning their symptoms reduce or disappear, by the end of the 28-week treatment period. Researchers will also monitor any side effects and track the time until disease symptoms worsen again.
Study on the Effects of Mepolizumab on Nasal Health and Immune Response in Patients with Eosinophilic Granulomatosis with Polyangiitis (eGPA)
This study, conducted in the Netherlands, examines how mepolizumab, given as an injection under the skin, affects the community of bacteria in the nose and the immune response in patients with this condition. The treatment lasts for three months with regular monitoring.
Who can participate: Individuals over 18 years old who can provide informed consent are eligible. Depending on their specific condition, they may need nasal polyps on both sides confirmed by examination, asthma with specific breathing test results, or meet expert criteria for related conditions established in 2022. Healthy controls without asthma symptoms may also participate.
Who cannot participate: Those with serious health conditions that could interfere with the study, pregnant or breastfeeding women, those with recent infections requiring antibiotics, those who received investigational drugs within 30 days, those with severe allergic reactions to medications, those with other autoimmune diseases, those with a cancer history (except certain treated skin cancers), those with recent drug or alcohol abuse, and those unable to follow study procedures are excluded.
Study focus: The research aims to understand how mepolizumab helps restore a healthy balance of microorganisms in the nose and improves the immune response. Mepolizumab works by targeting and reducing eosinophils, a type of white blood cell involved in inflammation, by blocking a protein called interleukin-5.
Study on the Effectiveness of Tezepelumab for Adults with Eosinophilic Granulomatosis with Polyangiitis (EGPA)
This Italian study evaluates tezepelumab, administered as a 210 mg injection under the skin once every four weeks, compared to a placebo over 24 weeks. The trial is double-blinded, meaning neither participants nor researchers know who receives the actual medication.
Who can participate: Adults between 18 and 75 years old with a confirmed diagnosis, a history of asthma, and elevated eosinophil levels are eligible. Participants must have at least two specific features such as eosinophilic vasculitis, certain inflammation types, nerve damage, lung issues, sinus abnormalities, heart muscle disease, kidney inflammation, lung bleeding, skin spots, or a positive ANCA test. Candidates must have experienced one or more disease flares in the last 24 months and be on stable doses of prednisolone and any immunomodulatory medications for at least four weeks.
Who cannot participate: Those without a confirmed diagnosis, those outside the age range, vulnerable populations unable to give consent, those in other clinical trials, those with conditions or medications that could interfere, those with severe allergic reactions to study medications, pregnant or breastfeeding women, and those with substance abuse histories are excluded.
Study focus: The primary goal is to determine how many patients achieve remission by week 24, defined as having no disease activity and taking 4 mg or less of prednisolone daily. The study also monitors the time until any flare-ups occur and the total time participants remain in remission.
Study on Benralizumab and Mepolizumab for Patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA) Receiving Standard Care
This trial, running across Germany, France, Italy, and Belgium, compares benralizumab and mepolizumab, both given as injections under the skin, against a placebo. Benralizumab is administered as a 30 mg dose, while mepolizumab follows its own dosing schedule. The study lasts 52 weeks with an additional open-label extension period.
Who can participate: Male and female participants aged 18 or older with a confirmed diagnosis including asthma history and high eosinophil levels are eligible. They must have at least two specific features such as certain inflammation types, nerve problems, lung issues, sinus problems, heart muscle disease, kidney inflammation, lung bleeding, skin rash, or positive ANCA test. Participants must have relapsing disease (at least one confirmed relapse in the last two years) or refractory disease (not achieving remission with standard treatment). They must be on stable doses of prednisolone or prednisone (7.5-50 mg daily) for four weeks and have acceptable heart test results. Women who can have children must use effective birth control.
Who cannot participate: Those with different conditions, those not receiving standard care, those without relapsing or refractory disease, those outside the age range, those not meeting gender criteria, and vulnerable populations are excluded.
Study focus: The trial evaluates how well benralizumab and mepolizumab help patients achieve and maintain remission, comparing their effectiveness and safety. Both medications work by reducing eosinophils, with benralizumab targeting the interleukin-5 receptor and mepolizumab inhibiting interleukin-5 directly.
Study on Mepolizumab and Drug Combination for Patients with Eosinophilic Granulomatosis with Polyangiitis
This French study compares a mepolizumab-based regimen with conventional treatment strategies that may include cyclophosphamide and azathioprine. Mepolizumab is given as an injection under the skin, while cyclophosphamide is administered by injection and azathioprine as oral tablets.
Who can participate: Patients aged 18 or older with a confirmed diagnosis, regardless of ANCA status, are eligible. They must have newly-diagnosed or relapsing disease with active disease defined by a Birmingham Vasculitis Activity Score of 3 or higher. Participants must be within the first 21 days after starting or increasing corticosteroids at a dose of 1 mg per kg per day or less. They must provide written informed consent and have health coverage through social security.
Who cannot participate: Those with different medical conditions, those outside the specified age range, vulnerable populations, those unable to follow study procedures, and those with health issues that might interfere with the study are excluded.
Study focus: The main goal is to determine if the mepolizumab-based regimen can reduce the need for glucocorticoids like prednisone, aiming for a dose of 4.0 mg or less per day by day 168 without relapse. The study monitors disease relapses, asthma and sinus exacerbations, and adverse events throughout the treatment period.
Study on the Effectiveness and Safety of Depemokimab vs. Mepolizumab for Adults with Relapsing or Refractory Eosinophilic Granulomatosis with Polyangiitis
This large multicenter trial across 11 European countries compares depemokimab, administered every 26 weeks, with mepolizumab, given every 4 weeks. Both are injected under the skin. The study also includes a placebo group and runs for 52 weeks.
Who can participate: Male and female participants aged 18 or older who weigh at least 40 kg are eligible. They must have a documented diagnosis for at least 6 months, including asthma and high eosinophil levels, along with at least two specific features such as certain inflammation types, nerve problems, lung issues, sinus problems, heart problems, kidney problems, lung bleeding, visible skin spots, or positive antibody tests. Participants must have relapsing disease (at least one confirmed relapse in the past 2 years) or refractory disease (not achieving remission while reducing medication). They must be on stable oral corticosteroid doses (7.5-50 mg daily) for four weeks and, if receiving immunosuppressive therapy, on stable doses for four weeks. Women who can have children must use highly effective birth control, and all participants must provide signed informed consent.
Who cannot participate: Those with different conditions, those not receiving standard care, those outside the age range, those not in the target population, and vulnerable populations are excluded.
Study focus: The trial aims to compare how well depemokimab works compared to mepolizumab in managing symptoms and maintaining remission. The primary goal is to achieve remission, defined as no disease activity and taking 4 mg or less of corticosteroids daily at both weeks 36 and 52. The study also measures the duration of remission, tracks relapses, and monitors corticosteroid usage throughout the treatment period.
Summary
Six clinical trials are currently investigating various treatment options for eosinophilic granulomatosis with polyangiitis across Europe. The studies are distributed across multiple countries, with the largest trial spanning 11 nations. Germany, France, Italy, and Belgium host the most trials, with four studies each conducted in these countries.
A notable pattern emerges in the medications being tested. Mepolizumab appears in four of the six trials, either as a primary investigational drug or as a comparator, highlighting its significant role in current research. The trials explore different aspects of treatment, from achieving remission and reducing corticosteroid dependence to understanding effects on nasal health and immune response.
The studies employ various approaches, including comparisons between different biologic medications, evaluations against placebo, and assessments of medication combinations with conventional therapies. Most trials focus on patients with relapsing or refractory disease who continue to experience symptoms despite standard treatment. Treatment durations range from three months to over a year, with some studies including extension periods for long-term evaluation.
All trials share common goals of achieving disease remission, reducing the need for corticosteroids, and monitoring safety. The research represents a comprehensive effort to identify more effective treatments while minimizing side effects for people living with this rare and challenging condition.
