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
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:
• Male and female children and adolescents from 6 to \< 18 years of age
• 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.
Locations
United States
Georgia
Emory University
RECRUITING
Atlanta
Indiana
Riley Hospital for Children
RECRUITING
Indianapolis
Minnesota
University of Minnesota Masonic Childrens Hospital Discovery Clinic
RECRUITING
Minneapolis
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Wake Forest University Health Sciences
RECRUITING
Charlotte
New York
Cohen Children Medical Center
RECRUITING
Lake Success
Ohio
Akron Childrens Hospital
RECRUITING
Akron
Cleveland Clinic Foundation
RECRUITING
Cleveland
Pennsylvania
University of Pittsburgh Medical Center Childrens Hospital of Pittsburgh
RECRUITING
Pittsburgh
Texas
Texas Childrens Hospital
RECRUITING
Houston
Other Locations
Belgium
Universitair Ziekenhuis Gent
RECRUITING
Ghent
Universitair Ziekenhuis Leuven - Gasthuisberg
RECRUITING
Leuven
Canada
Alberta Childrens Hospital
RECRUITING
Calgary
Stollery Childrens Hospital
RECRUITING
Edmonton
CHU Sainte Justine
RECRUITING
Montreal
France
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
RECRUITING
Bordeaux
Hospices Civils de Lyon Hopital Femme Mere Enfant
RECRUITING
Bron
Hopital Necker
RECRUITING
Paris
Hopital Necker Enfants Malades
RECRUITING
Paris
Hungary
Semmelweis Egyetem
RECRUITING
Budapest
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
RECRUITING
Szeged
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Uniwersytecki Szpital Dzieciecy w Krakowie
RECRUITING
Krakow
Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie
RECRUITING
Warsaw
Slovakia
Narodny ustav detskych chorob
RECRUITING
Bratislava
Spain
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
Hospital Sant Joan de Deu
RECRUITING
Esplugues De Llobregat
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2028-09-26
Participants
Target number of participants: 20
Treatments
Experimental: Avacopan
Participants will receive avacopan twice-daily (BID) administered as oral tablets or liquid formula for 52 weeks.
Related Therapeutic Areas
Sponsors
Leads: Amgen