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Clinical Trials in Japan / NCT06611696
Recruiting Phase 4

Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis

NCT06611696 · tracked via the Priya Life Science Japan tracker
Sponsor
Chiba University
Phase
Phase 4
Started
2024-11-15
Last updated
2025-05-04

Condition(s) studied

ANCA Associated Vasculitis (AAV)

Investigational drug(s) / intervention(s)

Avacopan, prednisolone and rituximabPrednisolone and rituximab

Avacopan, prednisolone and rituximab: Patients in the avacoapn group will be treated with avacoapn, short-term reduced-dose prednisolone and rituximab.

Prednisolone and rituximab: Patients in the glucocorticoid arm will be treated with reduced-dose prednisolone and rituximab.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Proportions of patients achieving remission — 26 weeks
    Remission is defined as BVAS (Birmingham vasculitis activity score)=0 and less than 5mg/day of prednisolone.

Trial sites (22)

FacilityCityRegionStatus
Fujita Health University Hospital Toyoake Aichi-ken Not Yet Recruiting
Asahi General Hospital Asahi Chiba Recruiting
Chiba Aoba Municipal Hospital Chiba Chiba Recruiting
Chiba University Chiba Chiba Recruiting
Chiba Rosai Hospital Ichihara Chiba Recruiting
Kameda Medical Centre Kamogawa Chiba Recruiting
International University of Health and Welfare Narita Chiba Recruiting
Japanese Red Cross Narita Hospital Narita Chiba Recruiting
Gunma University Maebashi Gunma Recruiting
Kagawa University Hiragi Kagawa-ken Recruiting
St.Marianna University School of Medicine Kawasaki Kanagawa Recruiting
Tohoku Univerisity Sendai Miyagi Recruiting
Nagasaki University Nagasaki Nagasaki Recruiting
Okayama University Okayama Okayama-ken Recruiting
Kitano Hospital Osaka Osaka Recruiting
Saitama Medical University Kawagoe Saitama Recruiting
Dokkyo Medical University Mibu Tochigi Recruiting
Juntendo Univeristy Bunkyoku Tokyo Recruiting
Kyorin University Mitaka Tokyo Recruiting
Toho University Ōta-ku Tokyo Recruiting
Teikyo University tabashi City Tokyo Recruiting
Yamanashi University Chuo-shi Yamanashi Recruiting

More Chiba University trials in Japan

Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN Recruiting
Effect of Surgical Masks in Preventing Acute Respiratory Infections Enrolling by invitation

Other trials for the same condition

Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06611696 on ClinicalTrials.gov ↗ ← All trials in Japan