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.
Running, not enrolling · Phase 3
Conditions studied: Vasculitis
In brief
The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.
Key facts
- Study ID
- NCT06321601
- Run by
- Amgen
- People needed
- 19
- Starts
- 2024-10-22
- Expected to finish
- 2027-07-18
- Last updated by the study team
- 2026-07-20
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
- University of Pittsburgh Medical Center 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
- British Columbia Childrens Hospital — Vancouver, British Columbia, Canada
- CHU Sainte Justine — Montreal, Quebec, Canada
- 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
Full record on ClinicalTrials.gov
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