Trials / Recruiting
RecruitingNCT06321601
Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV.
A Phase 3, Open-label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children From 6 Years to < 18 Years of Age With Active ANCA-associated Vasculitis (AAV)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avacopan | Oral administration |
Timeline
- Start date
- 2024-10-22
- Primary completion
- 2028-09-26
- Completion
- 2028-09-26
- First posted
- 2024-03-20
- Last updated
- 2026-03-06
Locations
30 sites across 9 countries: United States, Belgium, Canada, Czechia, France, Hungary, Poland, Slovakia, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06321601. Inclusion in this directory is not an endorsement.