Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis

Recruiting now · Phase 4

Conditions studied: ANCA Associated Vasculitis (AAV)

In brief

The goal of this clinical trial is to learn if avacopan in combination with short-term (4 weeks) reduced-dose glucocorticoid and rituximab works to treat patients with newly-onset ANCA-associated vasculitis. It will also learn about the long-term safety of avacopan. The main questions it aims to answer are: Is avacopan in combination with short-term reduced-dose glucocorticoid and rituximab as effective as the combination of 20 week reduced-dose glucocorticoid and rituximab in the proportion of the patients achieving remission? Does avacopan lower the relapse rate compared to the 6 monthly rituximab maintenance therapy? What medical problems do participants have when taking long-term avacopan? Participants will: Be treated with avacopan in combination with short-term (until 4 weeks) reduced-dose glucocorticoid and rituximab (at 0 week) or reduced-dose glucocorticoid (until 20 weeks) and rituximab (at 0, 26, 52 and 78 weeks). Be assessed at 0, 4, 8, 16, 26, 52, 78 and 104 weeks regarding disease status (remission/relapse), disease activity by Birmingham Vasculitis Activity Score ver3, disease damage by Vasculitis Damage Index and adverse events. The primary endpoint is remission rates at 26 weeks.

Key facts

Study ID

NCT06611696

Run by

Chiba University

People needed

160

Starts

2024-11-15

Expected to finish

2028-09-30

Last updated by the study team

2025-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of written informed consent by a patient or a surrogate decision maker
• Age=\>18 years
• 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
• Positive test by ELISA, CLEIA or FEIA for proteinase 3-ANCA or myeloperoxidase-ANCA

You may not qualify if…

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

Where it is running

• Yamanashi University — Chuo-shi, Yamanashi, Japan (enrolling)
• Asahi General Hospital — Asahi, Chiba, Japan (enrolling)
• Chiba Aoba Municipal Hospital — Chiba, Chiba, Japan (enrolling)
• Chiba University — Chiba, Chiba, Japan (enrolling)
• Chiba Rosai Hospital — Ichihara, Chiba, Japan (enrolling)
• Kameda Medical Centre — Kamogawa, Chiba, Japan (enrolling)
• International University of Health and Welfare — Narita, Chiba, Japan (enrolling)
• Japanese Red Cross Narita Hospital — Narita, Chiba, Japan (enrolling)
• Gunma University — Maebashi, Gunma, Japan (enrolling)
• Kagawa University — Hiragi, Kagawa-ken, Japan (enrolling)
• St.Marianna University School of Medicine — Kawasaki, Kanagawa, Japan (enrolling)
• Tohoku Univerisity — Sendai, Miyagi, Japan (enrolling)
• Nagasaki University — Nagasaki, Nagasaki, Japan (enrolling)
• Okayama University — Okayama, Okayama-ken, Japan (enrolling)
• Kitano Hospital — Osaka, Osaka, Japan (enrolling)
• Saitama Medical University — Kawagoe, Saitama, Japan (enrolling)
• Dokkyo Medical University — Mibu, Tochigi, Japan (enrolling)
• Juntendo Univeristy — Bunkyoku, Tokyo, Japan (enrolling)
• Kyorin University — Mitaka, Tokyo, Japan (enrolling)
• Toho University — Ōta-ku, Tokyo, Japan (enrolling)
• Teikyo University — tabashi City, Tokyo, Japan (enrolling)
• Fujita Health University Hospital — Toyoake, Aichi-ken, Japan

Full record on ClinicalTrials.gov

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