Clinical Trials in Spain / 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 Spain tracker
Condition(s) studied
Vasculitis
Study summary
The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.
Eligibility
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)
- Proportion of Participants Achieving Disease Remission at Week 26 According to the Pediatric Vasculitis Activities Score (PVAS) — Week 26
- Proportion of Participants With Sustained Disease Remission at Week 52 According to the PVAS — Week 52
Trial sites (34)
| Facility | City | Region | Status |
|---|---|---|---|
| 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) |
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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 Spain