Ongoing Clinical Trials for Microscopic Polyangiitis
There are currently 2 clinical trials recruiting patients with microscopic polyangiitis, a rare autoimmune condition affecting blood vessels. These studies are testing new medications aimed at achieving better disease control and remission. Trials are taking place across multiple European countries, including Germany, Spain, Denmark, Hungary, Austria, France, Netherlands, Belgium, and Czechia.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- France
- Germany
- Hungary
- Netherlands
- Spain
Study of iptacopan effectiveness in achieving remission in patients with active ANCA-associated vasculitis
This trial is evaluating iptacopan (also known as LNP023), a new oral medication for treating ANCA-associated vasculitis, which includes microscopic polyangiitis. The medication works by blocking a specific part of the immune system called the complement pathway, aiming to reduce inflammation and help patients achieve and maintain remission.
Main inclusion criteria:
- Must be 18 years or older
- Must have newly diagnosed or relapsed microscopic polyangiitis or granulomatosis with polyangiitis requiring treatment with rituximab and glucocorticoids
- Must have a Birmingham Vasculitis Activity Score (BVAS) showing at least 1 major symptom, or at least 3 minor symptoms, or at least 2 kidney-related symptoms
- Must have positive blood test for anti-PR3 or anti-MPO antibodies during screening, or previous documented evidence of a positive test
Main exclusion criteria:
- History of severe allergic reactions to medications
- Pregnancy or breastfeeding
- Active or chronic infections including hepatitis B, hepatitis C, or HIV
- Severe liver or kidney disease requiring dialysis
- History of cancer within the past 5 years (except successfully treated skin cancer)
- Uncontrolled high blood pressure
- Participation in other clinical trials within the past 30 days
What to expect during the trial:
The study will last for 48 weeks. Participants will receive either iptacopan or placebo capsules taken by mouth, along with standard treatments including rituximab and glucocorticoids. Throughout the study, there will be regular monitoring of disease activity, kidney function, and urine tests. At 24 weeks, doctors will assess whether patients have achieved complete remission. The monitoring continues through week 48 to evaluate sustained remission and check for any signs of disease relapse.
Investigational drug: Iptacopan (LNP023) is given as hard gelatin capsules taken by mouth. It represents a new approach to treating vasculitis by targeting the alternative complement pathway of the immune system.
Study on Imlifidase for Patients with Severe ANCA-Associated Vasculitis and Lung Bleeding
This trial focuses on patients with severe ANCA-associated vasculitis who are experiencing serious bleeding in the lungs, known as pulmonary hemorrhage. The study is testing imlifidase, a medication given through intravenous infusion, alongside standard care treatments.
Main inclusion criteria:
- Must have a new or previous clinical diagnosis of ANCA-associated vasculitis, including microscopic polyangiitis or granulomatosis with polyangiitis
- Must have an ANCA titer of 50 or higher, measured no more than 14 days before joining the study
- Must have pulmonary hemorrhage due to active vasculitis, confirmed by chest x-ray or CT scan and at least one additional sign such as coughing up blood, evidence of bleeding from bronchoscopy, unexplained anemia, or acute respiratory distress syndrome
- Female participants must be post-menopausal (no periods for at least 12 months)
Main exclusion criteria:
- Any other serious medical condition that might interfere with the study
- Pregnancy or breastfeeding
- Participation in another clinical trial within the last 30 days
- Known allergy to the study medication or its ingredients
- History of drug or alcohol abuse within the past year
- Severe liver or kidney disease
- Active infections requiring treatment
- History of cancer within the last 5 years, except for certain skin cancers
What to expect during the trial:
After providing written consent and undergoing a detailed medical evaluation including blood tests and imaging studies, participants will receive imlifidase as an intravenous infusion. The primary goal is to observe how quickly the medication can reduce ANCA levels within 24 hours. Throughout the study, participants will have regular check-ups to track their response to treatment, including monitoring of ANCA levels, lung and kidney function, and any potential side effects. At the end of the study period, a final assessment will evaluate overall health and treatment effects.
Investigational drug: Imlifidase is an enzyme-based therapy administered directly into the bloodstream through a vein. It works by breaking down specific proteins in the immune system involved in the disease, helping to reduce inflammation and damage, particularly in cases with severe lung bleeding.
Summary
Both ongoing clinical trials for microscopic polyangiitis focus on ANCA-associated vasculitis, reflecting the shared disease mechanism. The first trial testing iptacopan is more widely available across nine European countries, offering access to a broader patient population with active disease. This study takes an oral medication approach and aims to achieve sustained remission over 48 weeks alongside standard treatments.
The second trial testing imlifidase is currently only available in Germany and targets a more specific and severe presentation of the disease – patients experiencing life-threatening lung bleeding. This study uses an intravenous medication approach and focuses on rapid reduction of disease-causing antibodies.
Both trials represent important advances in treatment options, with iptacopan targeting the complement pathway through oral medication and imlifidase using enzyme-based therapy to directly break down harmful immune proteins. The availability of these trials provides patients with different disease severity levels access to potentially beneficial new treatments.
