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Imlifidase in ANCA-associated Vasculitis
EU CTIS ID: 2024-516727-13-00
What this study is testing
Define efficacy of imlifidase plus standard of care (SoC) in severe ANCAassociated vasculitis with pulmonary hemorrhage
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- New or previous clinical diagnosis of ANCA-associated vasculitis, (granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) consistent with revised Chapel Hill definitions
- ANCA titer >= 50 (AU/ml) (i.e. anti-myeloperoxidase / antiproteinase 3) no more than 14 days prior to inclusion measured by certified clinical laboratory
- Pulmonary hemorrhage due to active vasculitis defined by the following: o A compatible chest x-ray or CT scan (diffuse pulmonary infiltrates) o The absence of an alternative explanation for all pulmonary infiltrates (i.e. volume overload or pulmonary infection) o At least one of the following: § Evidence of alveolar hemorrhage on bronchoscopic examination or increasingly bloody returns with bronchoalveolar lavage § Observed hemoptysis § Unexplained anemia (<10 g/dL) or documented drop in hemoglobin (>1 g/dL) from less than 10g/dl § Acute respiratory distress syndrome (ARDS, according to Berlin definition)
- Provision of written informed consent by patients before any study related procedure
- Willingness and ability to comply with the protocol
- For female subjects: Confirmed post-menopausal state (defined as amenorrhea for at least 12 months)
You likely can't join if
- Subjects aged < 18 or > 80 years
- Previous treatment with imlifidase
- Previous or ongoing high dose IVIg treatment (2 g/kg) within 28 days prior to inclusion
- More than two plasma exchanges prior to administration of imlifidase within 28 days prior to inclusion
- Participation in an other interventional clinical trial or intake of other investigational medicinal product within 5 half-lives (or similar) of the product prior to inclusion
- Symptomatic congestive heart failure (NYHA class 2-4) requiring prescription medication or clinically evident peripheral edema of cardiac origin or documented evidence/history of NYHA class 2-4 heart failure
See the full eligibility criteria
Who can join
- New or previous clinical diagnosis of ANCA-associated vasculitis, (granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) consistent with revised Chapel Hill definitions
- ANCA titer >= 50 (AU/ml) (i.e. anti-myeloperoxidase / antiproteinase 3) no more than 14 days prior to inclusion measured by certified clinical laboratory
- Pulmonary hemorrhage due to active vasculitis defined by the following: o A compatible chest x-ray or CT scan (diffuse pulmonary infiltrates) o The absence of an alternative explanation for all pulmonary infiltrates (i.e. volume overload or pulmonary infection) o At least one of the following: § Evidence of alveolar hemorrhage on bronchoscopic examination or increasingly bloody returns with bronchoalveolar lavage § Observed hemoptysis § Unexplained anemia (<10 g/dL) or documented drop in hemoglobin (>1 g/dL) from less than 10g/dl § Acute respiratory distress syndrome (ARDS, according to Berlin definition)
- Provision of written informed consent by patients before any study related procedure
- Willingness and ability to comply with the protocol
- For female subjects: Confirmed post-menopausal state (defined as amenorrhea for at least 12 months)
What rules you out
- Subjects aged < 18 or > 80 years
- Previous treatment with imlifidase
- Previous or ongoing high dose IVIg treatment (2 g/kg) within 28 days prior to inclusion
- More than two plasma exchanges prior to administration of imlifidase within 28 days prior to inclusion
- Participation in an other interventional clinical trial or intake of other investigational medicinal product within 5 half-lives (or similar) of the product prior to inclusion
- Symptomatic congestive heart failure (NYHA class 2-4) requiring prescription medication or clinically evident peripheral edema of cardiac origin or documented evidence/history of NYHA class 2-4 heart failure
- A comorbidity or indication of such based on medical history, physical examination, and clinical laboratory assessments which precludes the use of cyclophosphamide, glucocorticoids, or imlifidase.
- Evidence of moderate or severe hepatic impairment indicated by elevated aminotransferases (ALT or AST) or bilirubin greater than double (2.0 x) the upper limit of normal (ULN)
- Ongoing bacterial or fungal infection requiring antibiotic /-fungal therapy (or completed within 7 days prior to inclusion). Viral infection with Hepatitis B, C and HIV (up to 14 days old negative test results are accepted); or active tuberculosis as indicated by chest X-ray. Every patient will be screened for SARS-CoV2, positive cases will be excluded.
- Active malignant disease or a history of malignancy within two years prior to diagnosis/infusion other than non-melanoma resected or cured skin cancer
- Any condition that in the opinion of the investigator could increase the subject's risk by participating in the study other than those specified.
- Subjects physically or mentally unable to give written informed consent
- Present or history of thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP
- Subject who might be dependent on the sponsor, the investigator or the trial site.
- Subjects deprived of freedom i.e., detainment or commitment to psychiatric ward, prison or state institution by law court or legal authority
- Female subjects: pregnant or breastfeeding or of childbearing potential
- Male subjects: unwilling to use double-barrier contraception for the duration of this study.
- Concomitant autoimmunological disease (e.g. Goodpasture, vasculitis other than AAV)
- Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) consistent with revised Chapel Hill definitions
- Concomitant pulmonary disease (e.g. chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD))
- Known allergy/sensitivity to imlifidase, IVIg and/or the respective excipients
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.