ANVIL
Trial Status: In Set-Up
Anti-neutrophil cytoplasm antibody associated vasculitis treated with Interleukin-2 (ANVIL) therapy: proof of concept study.
Short Title |
The role of Interleukin-2 therapy in patients with ANCA associated vasculitis (AAV) |
Trial Acronym |
ANVIL |
Chief Investigator |
Professor Raashid Luqmani |
Sponsor |
University of Oxford |
Funder |
Wellcome |
Clinical Phase |
II |
Trial Design |
Prospective Phase 2, single centre, open-label, proof of concept trial |
Planned sample size |
10 |
Planned trial period |
23 months: 14 months recruitment, 3 months treatment, 6 months follow-up |
Target population |
Patients with new onset or flaring AAV (including Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) and undifferentiated AAV). All patients should have active disease defined using the Birmingham Vasculitis Activity Score (BVAS). Patients will have new or flaring disease with severe features requiring rituximab (RTX) or cyclophosphamide (BVAS ≥6) and will be initiated on aldesleukin therapy when their BVAS level falls to <6. |
Investigational Medicinal Product(s) |
Aldesleukin |
Primary objective:
To assess whether low dose aldesleukin therapy can control moderate active disease in AAV.
SECONDARY OBJECTIVES:
To determine the effect of aldesleukin therapy on controlling damage occurring as a result of disease or its treatment after 6 months of follow up.
To determine the safety of ultra-low dose aldesleukin therapy in patients with AAV.
Steroid related toxicity
Inclusion criteria |
|
Exclusion criteria |
Participants who have participated in another research trial involving an investigational product in the past 12 weeks. |