Avacopan treatment for ANCA-associated vasculitis
Avacopan With Short-term Reduced-dose Glucocorticoids vs Reduced-dose Glucocorticoids Added to Rituximab on Remission Induction in ANCA-associated Vasculitis
PHASE4 · Chiba University · NCT06611696
This study is testing if avacopan, used with a lower dose of steroids and rituximab, can help people with newly diagnosed ANCA-associated vasculitis feel better compared to a longer course of steroids.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chiba University (other) |
| Drugs / interventions | rituximab, belimumab, cyclophosphamide |
| Locations | 22 sites (Toyoake, Aichi-ken and 21 other locations) |
| Trial ID | NCT06611696 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with a new diagnosis of ANCA-associated vasculitis and positive ANCA tests.
Not a fit: Patients with prior treatment for ANCA-associated vasculitis or severe complications like glomerulonephritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved remission rates and reduced side effects for patients with ANCA-associated vasculitis.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toyoake, Aichi-ken and 21 other locations
- Fujita Health University Hospital — Toyoake, Aichi-ken, Japan (NOT_YET_RECRUITING)
- 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)
- Japanese Red Cross Narita Hospital — Narita, Chiba, Japan (RECRUITING)
- Gunma University — Maebashi, Gunma, Japan (RECRUITING)
- Kagawa University — Hiragi, Kagawa-ken, Japan (RECRUITING)
- St.Marianna University School of Medicine — Kawasaki, Kanagawa, Japan (RECRUITING)
- Tohoku Univerisity — Sendai, Miyagi, Japan (RECRUITING)
- Nagasaki University — Nagasaki, Nagasaki, Japan (RECRUITING)
- Okayama University — Okayama, Okayama-ken, Japan (RECRUITING)
- Kitano Hospital — Osaka, Osaka, Japan (RECRUITING)
- Saitama Medical University — Kawagoe, Saitama, Japan (RECRUITING)
- Dokkyo Medical University — Mibu, Tochigi, Japan (RECRUITING)
- Juntendo Univeristy — Bunkyoku, Tokyo, Japan (RECRUITING)
- Kyorin University — Mitaka, Tokyo, Japan (RECRUITING)
- Toho University — Ōta-ku, Tokyo, Japan (RECRUITING)
- Teikyo University — tabashi City, Tokyo, Japan (RECRUITING)
- Yamanashi University — Chuo-shi, Yamanashi, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ANCA Associated Vasculitis, microscopic polyangiitis, granulomatosis with polyangiitis, avacopan, ANCA-associated vasculitis