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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

  1. Participant is willing and able to give informed consent for participation in the trial.
  2. Male or Female, aged 18 years or above.
  3. A diagnosis of new or flaring AAV (but not eosinophilic granulomatosis with polyangiitis-EGPA) within the previous 6 weeks.
  4. Evidence of active disease at the time of recruitment into the study, defined as follows:
    1. At screening, BVAS ≥6 for new or flaring cases, which responds to standard care treatment resulting in a BVAS score of <6 after 6 weeks.
  5. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.

 

Exclusion criteria

  1. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
  2. Females of childbearing potential who are unwilling or unable to comply with contraceptive advice and regular pregnancy testing throughout the trial
  3. Male participants whose partner is of child bearing potential who are unwilling or unable to comply with contraceptive advice throughout the trial
  4. Contraindication to starting standard induction therapy for active vasculitis (such as the presence of significant active infection which would require delay in initiating induction therapy for vasculitis)
  5. Dialysis-dependent renal impairment
  6. Pre-existing autoimmune disease (excluding AAV)
  7. Use of a high dose of glucocorticoid therapy for management of current disease for more than 1 month immediately prior to screening for the study (>20mg prednisolone/day).
  8. Long term (>1 month) high dose (>20mg prednisolone/day at any time) glucocorticoid, within three months prior to screening.
  9. Hypersensitivity to aldesleukin or any of the excipients
  10. Concurrent treatment with hepatotoxic, nephrotoxic, myelotoxic, or cardiotoxic products
  11. History of severe cardiac disease (NYHA Class III or IV)
  12. History of malignancy within the past 5 years (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
  13. Active clinical infections – patients can be recruited after a minimum period of 48 hours  after last day of feeling unwell or last day of antibiotic/anti-viral treatment
  14. Immunisations – patients can be recruited after a minimum of 14 days following immunisation. Routine vaccinations should be avoided for the duration of treatment and for 30 days afterwards
  15. Any medical history or clinically relevant abnormality that is deemed by the Principal Investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern.

Participants who have participated in another research trial involving an investigational product in the past 12 weeks.