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.
NCT ID: NCT06321601
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
20 participants
INTERVENTIONAL
2024-10-22
2028-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Avacopan
Participants will receive avacopan twice-daily (BID) administered as oral tablets or liquid formula for 52 weeks.
Avacopan
Oral administration
Interventions
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Avacopan
Oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013)
* Newly diagnosed or relapsed AAV with positive test for anti-PR3 or anti-MPO antibodies
* At least 1 PVAS major item, at least 3 PVAS nonmajor items, or at least the 2 renal items of proteinuria and hematuria.
* eGFR \> 15 mL/min/1.73 m2 (using modified Schwartz equation per central lab guidelines)
* Participants must have a bodyweight of ≥ 15 kg at day 1.
Exclusion Criteria
* Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study
* Any medical condition requiring or expected to require continued use of immunosuppressive treatments, including corticosteroids that may cause confoundment with study assessments and study conclusions.
6 Years
17 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Emory University
Atlanta, Georgia, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Minnesota Masonic Childrens Hospital Discovery Clinic
Minneapolis, Minnesota, United States
Cohen Children Medical Center
Lake Success, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
Charlotte, North Carolina, United States
Akron Childrens Hospital
Akron, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Upmc Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Texas Childrens Hospital
Houston, Texas, United States
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitair Ziekenhuis Leuven - Gasthuisberg
Leuven, , Belgium
Alberta Childrens Hospital
Calgary, Alberta, Canada
Stollery Childrens Hospital
Edmonton, Alberta, Canada
CHU Sainte Justine
Montreal, Quebec, Canada
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux, , France
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron, , France
Hopital Necker Enfants Malades
Paris, , France
Semmelweis Egyetem
Budapest, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, , Hungary
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, , Poland
Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie
Warsaw, , Poland
Narodny ustav detskych chorob
Bratislava, , Slovakia
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20230070
Identifier Type: -
Identifier Source: org_study_id
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