Avacopan treatment for ANCA-associated vasculitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of avacopan in combination with a short-term reduced-dose glucocorticoid and rituximab for treating newly diagnosed ANCA-associated vasculitis. Participants will be randomly assigned to receive either avacopan with reduced-dose glucocorticoids for 4 weeks or a longer course of reduced-dose glucocorticoids for 20 weeks, both alongside rituximab. The study will assess remission rates, relapse rates, and long-term safety of avacopan over a period of up to 104 weeks. The trial is designed to provide insights into the potential benefits of avacopan compared to traditional therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provision of written informed consent by a patient or a surrogate decision maker
2. Age=\>18 years
3. New clinical diagnosis of ANCA-associated vasculitis (granulomatosis with polyangiitis, microscopic polyangiitis) consistent with the 2012 Chapel Hill consensus definitions and 2022 EULAR/ACR classification criteria
4. Positive test by ELISA, CLEIA or FEIA for proteinase 3-ANCA or myeloperoxidase-ANCA

Exclusion Criteria:

1. Prior treatment for ANCA-associated vasculitis before trial entry
2. ANCA-associated vasculitis related glomerulonephritis (eGFR less than 15ml/min) or alveolar hemorrhage (oxygen inhalation more than 2L/min)
3. Presence of another multisystem autoimmune disease
4. Known infection with HIV; a past or current history of hepatitis B virus or hepatitis C virus infection
5. Desire to bear children, pregnancy or lactating
6. History of malignancy within the past 5 years or any evidence of persistent malignancy
7. Ongoing or recent (last 1 year) evidence of active tuberculosis
8. History of severe allergy or anaphylaxis to monoclonal antibody therapy
9. Any concomitant condition anticipated to likely require oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange or IVIg
10. Any biological B cell depleting agent (such as rituximab or belimumab)-use within the past 6 months
11. Past history of medication of avacopan
12. Patients can not take avacopan and prednisolone orally
13. Other conditions, in the investigator\'s opinion, inappropriate for the trial entry

Where it's running

• Asahi General Hospital
  Asahi, Chiba, Japan Recruiting
• Chiba Aoba Municipal Hospital
  Chiba, Chiba, Japan Recruiting
• Chiba University
  Chiba, Chiba, Japan Recruiting
• Chiba Rosai Hospital
  Ichihara, Chiba, Japan Recruiting
• Kameda Medical Centre
  Kamogawa, Chiba, Japan Recruiting
• International University of Health and Welfare
  Narita, Chiba, Japan Recruiting

Study contacts

• Principal investigator: Masayoshi Harigai, MD, PhD — International University of Health and Welfare
• Study coordinator: Shunsuke Furuta, MD, PhD
• Email: shfuruta@chiba-u.jp
• Phone: 81+43-222-7171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.