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Clinical Studies


  • A 52-week, Randomized, Double-blind, Double-dummy, Parallel-group, Multi-centre, Non-inferiority Study to Investigate the Efficacy and Safety of Depemokimab Compared with Mepolizumab in Adults with Relapsing or Refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) Receiving Standard of Care (SoC) Therapy (OCEAN) Rochester, Minn.

    The primary objective of the study is to evaluate the effectiveness of depemokimab 200 mg SC every 26 weeks compared with mepolizumab 300 mg SC every 4 weeks in participants with relapsing or refractory EGPA receiving Standard of Care (SoC) therapy with the endpoint of remission (i.e., a Birmingham Vasculitis Activity Score (BVAS)=0 and a dose of oral corticosteroids (OCS) ≤ 4mg/day) at both Week 36 and Week 52.

    The aim of this study is to investigate the effectiveness and safety of depemokimab 200 mg (administered as 100 mg x 2) SC injections every 26 weeks compared with mepolizumab 300 mg (administered as 100 mg x 3) SC injections every 4 weeks in participants with relapsing or refractory EGPA receiving SoC therapy, over a 52-week intervention period.

    Depemokimab is a humanised, affinity matured monoclonal antibody that blocks human interleukin-5 (IL-5) binding to its receptor. Depemokimab is being developed as a long‑acting subcutaneous injectable anti-IL-5 (anti-IL-5) therapy and is expected to deliver an efficacy and safety profile similar to the current anti-IL-5 therapies with a reduced dosing frequency (once every 26 weeks).



  • A Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effect of Obinutuzumab versus Rituximab in PR3-Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (PRRR) Rochester, Minn.

    The purpose of this study is to determine the proportion of patients achieving both complete remission and seronegativity for Anti-Neutrophil Cytoplasmic Antibody (ANCA) at 6 months. 

    The study is a double-blind, randomized, active controlled phase 2 study.  It will take place at multiple sites and enroll 30 patients who have clinical diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis (PR3-AAV).  It will look at the study drug, Obinutuzumab, for the treatment of these diagnosis and evaulate the safety of the drug.  Subjects will be followed for 18 months after first treatment.  The study will complete when all enrolled subjects are have been followed for 18 months or have withdrawn.  

  • Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis (LoDoNaVasc) Rochester, Minn.

    The purpose of this clinical trial is to determine if low dose naltrexone is effective in improving health-related quality of life (HRQoL) among patients with vasculitis. Although it is a pilot study, a placebo-controlled component is used because of the prominent placebo group effect seen in studies with self-reported subjective outcomes.

    Naltrexone is an FDA approved drug (for alcoholism) that has found widespread use "off-label" to treat pain and improve quality of life at much lower doses than are used for the approved indication. There are a few scientific studies in three conditions (fibromyalgia, Crohn's disease, and multiple sclerosis) that suggest that this drug has benefit and is safe. However, considering the extent of use in other conditions, and uncertainty about the mechanism of action study is needed in a diverse set of diseases, including vasculitis.

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