Actively Recruiting
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.
Led by Amgen · Updated on 2026-05-14
20
Participants Needed
32
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female children and adolescents from 6 to < 18 years of age
- Clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) per Chapel-Hill Consensus definitions
- Newly diagnosed or relapsed AAV with positive anti-PR3 or anti-MPO antibodies
- At least 1 major item or 3 nonmajor items on the Pediatric Vasculitis Activities Score (PVAS), or the 2 renal items of proteinuria and hematuria
- Estimated glomerular filtration rate (eGFR) > 15 mL/min/1.73 m2 using modified Schwartz equation
- Bodyweight of at least 15 kg at day 1
You will not qualify if you...
- Any other known multisystem autoimmune disease including eosinophilic granulomatosis with polyangiitis, systemic lupus erythematosus, IgA vasculitis, rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis
- Alveolar hemorrhage requiring invasive pulmonary ventilation support expected beyond screening
- Medical conditions requiring ongoing immunosuppressive treatments, including corticosteroids, that may interfere with study assessments or conclusions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
University of Minnesota Masonic Childrens Hospital Discovery Clinic
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
4
Cohen Children Medical Center
Lake Success, New York, United States, 11042
Actively Recruiting
5
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
6
Wake Forest University Health Sciences
Charlotte, North Carolina, United States, 28203
Actively Recruiting
7
Akron Childrens Hospital
Akron, Ohio, United States, 44308
Actively Recruiting
8
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
9
University of Pittsburgh Medical Center Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
10
Texas Childrens Hospital
Houston, Texas, United States, 77030
Actively Recruiting
11
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
12
Universitair Ziekenhuis Leuven - Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
13
Alberta Childrens Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
14
Stollery Childrens Hospital
Edmonton, Alberta, Canada, T6G 1C9
Actively Recruiting
15
British Columbia Childrens Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Actively Recruiting
16
CHU Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
17
Vseobecna fakultni nemocnice v Praze
Prague, Czechia, 128 08
Actively Recruiting
18
Fakultni nemocnice v Motole
Prague, Czechia, 150 06
Actively Recruiting
19
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux, France, 33076
Actively Recruiting
20
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron, France, 69677
Actively Recruiting
21
Hopital Necker Enfants Malades
Paris, France, 75015
Actively Recruiting
22
Hopital Necker
Paris, France, 75015
Actively Recruiting
23
Semmelweis Egyetem
Budapest, Hungary, 1094
Actively Recruiting
24
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, Hungary, 6720
Terminated
25
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Actively Recruiting
26
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Poland, 30-663
Actively Recruiting
27
Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie
Warsaw, Poland, 02-091
Actively Recruiting
28
Narodny ustav detskych chorob
Bratislava, Slovakia, 833 40
Actively Recruiting
29
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
30
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, Spain, 08950
Actively Recruiting
31
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
32
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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