NCT06611696 Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis
| NCT ID | NCT06611696 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chiba University |
| Condition | ANCA Associated Vasculitis (AAV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 160 participants in total. It began in 2024-11-15 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Masayoshi Harigai, MD, PhD
PRINCIPAL INVESTIGATOR
International University of Health and Welfare
Frequently Asked Questions
Who can join the NCT06611696 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ANCA Associated Vasculitis (AAV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06611696 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06611696 currently recruiting?
Yes, NCT06611696 is actively recruiting participants. Contact the research team at shfuruta@chiba-u.jp for enrollment information.
Where is the NCT06611696 trial being conducted?
This trial is being conducted at Toyoake, Japan, Asahi, Japan, Chiba, Japan, Chiba, Japan and 11 additional locations.
Who is sponsoring the NCT06611696 clinical trial?
NCT06611696 is sponsored by Chiba University. The principal investigator is Masayoshi Harigai, MD, PhD at International University of Health and Welfare. The trial plans to enroll 160 participants.