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Clinical Trials in the USA / NCT06321601
Active, not recruiting Phase 3

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.

NCT06321601 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 3
Started
2024-10-22
Last updated
2026-07-20

Condition(s) studied

Vasculitis

Investigational drug(s) / intervention(s)

Avacopan

Avacopan: Oral administration

Study summary

The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Male and female children and adolescents from 6 to \< 18 years old of age. * Clinical diagnosis of Granulomatosis with Polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013). * Positive anti-PR3(Anti-Proteinase 3) or anti-MPO(Anti-Myeloperoxidase) antibody documented at Screening or historically. Historical positivity is acceptable (even if Screening is negative) if supported by verifiable lab source documentation obtained during AAV diagnosis or disease course; use the most recent positive result. * At least 1 PVAS major item, at least 3 PVAS nonmajor items, or atleast the 2 renal items of proteinuria and hematuria. * Estimated glomerular filtration rate (eGFR) of ≥ 15 mL/minute/1.73 m\^2 at screening and day 1. * Participants must have a bodyweight of ≥ 15 kg at day 1. Exclusion Criteria: * Any other known multisystem autoimmune disease including and not limited to eosinophilic granulomatosis with polyangiitis (EGPA, previously, Churg-Strauss disease), systemic lupus erythematosus, IgA vasculitis / Henoch-Schönlein, Purpura, rheumatoid vasculitis, Sjögren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis. * Renal replacement therapy / plasmapheresis: subjects will be excluded who received, require, or initiate CRRT (continuous renal replacement therapy), hemodialysis, any renal dialysis, or plasmapheresis within 14 days prior to Screening or between Screening and Day 1. * History of kidney transplantation or is anticipated to require renal transplantation during the study. * 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, ongoing treatment with immunosuppressive, therapy (including systemic glucocorticoids) for a non-AAV indication that in the judgment of the investigator, could confound study assessments or interpretation of study results. * Female subjects of childbearing potential must have a negative highly sensitive serum pregnancy test at Screening and a negative sensitive urine pregnancy test, on day 1, with results confirmed prior to the first administration of investigational product. * Known hypersensitivity or contraindication to avacopan, its excipients, or to any investigational product or required concomitant medication used in this study. * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge. * History or evidence of any other clinically significant disorder, condition, or disease (other than those specified above) that, in the investigator's judgment, would pose an unacceptable risk to subject safety, or interfere with study assessments or completion. The investigator may consult the Amgen medical monitor as needed. The rationale for exclusion and any consultation must be documented in the subject's source record.

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
Emory University Atlanta Georgia
Riley Hospital for Children Indianapolis Indiana
University of Minnesota Masonic Childrens Hospital Discovery Clinic Minneapolis Minnesota
Cohen Children Medical Center Lake Success New York
University of North Carolina Chapel Hill North Carolina
Wake Forest University Health Sciences Charlotte North Carolina
Akron Childrens Hospital Akron Ohio
Cleveland Clinic Foundation Cleveland Ohio
University of Pittsburgh Medical Center Childrens Hospital of Pittsburgh Pittsburgh Pennsylvania
Texas Childrens Hospital Houston Texas
Universitair Ziekenhuis Gent Ghent Belgium
Universitair Ziekenhuis Leuven - Gasthuisberg Leuven Belgium
Alberta Childrens Hospital Calgary Alberta
Stollery Childrens Hospital Edmonton Alberta
British Columbia Childrens Hospital Vancouver British Columbia
CHU Sainte Justine Montreal Quebec
Vseobecna fakultni nemocnice v Praze Prague Czechia
Fakultni nemocnice Motol a Homolka 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
Hopital Necker 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
Hospital Sant Joan de Deu Esplugues de Llobregat Catalonia
Hospital Universitario 12 de Octubre Madrid Spain
Hacettepe Universitesi Tip Fakultesi Hastanesi Ankara Turkey (Türkiye)
Umraniye Egitim ve Arastirma Hastanesi Istanbul Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Hastanesi Kayseri Turkey (Türkiye)

More Amgen trials in the USA

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 NCT06321601 on ClinicalTrials.gov ↗ ← All trials in the USA