๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-17

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)

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)

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Amgen

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: Emory University โ€” Atlanta, Georgia

Age range: 6 Years to 17 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (34 Sites)

Showing the first 25 of 34 sites.

  • Emory University โ€” Atlanta, Georgia
  • Riley Hospital for Children โ€” Indianapolis, Indiana
  • University of Minnesota Masonic Childrens Hospital Discovery Clinic โ€” Minneapolis, Minnesota
  • Cohen Children Medical Center โ€” Lake Success, New York
  • University of North Carolina โ€” Chapel Hill, North Carolina
  • Wake Forest University Health Sciences โ€” Charlotte, North Carolina
  • Akron Childrens Hospital โ€” Akron, Ohio
  • Cleveland Clinic Foundation โ€” Cleveland, Ohio
  • University of Pittsburgh Medical Center Childrens Hospital of Pittsburgh โ€” Pittsburgh, Pennsylvania
  • Texas Childrens Hospital โ€” Houston, Texas
  • Universitair Ziekenhuis Gent โ€” Ghent,
  • Universitair Ziekenhuis Leuven - Gasthuisberg โ€” Leuven,
  • Alberta Childrens Hospital โ€” Calgary, Alberta
  • Stollery Childrens Hospital โ€” Edmonton, Alberta
  • British Columbia Childrens Hospital โ€” Vancouver, British Columbia
  • CHU Sainte Justine โ€” Montreal, Quebec
  • Vseobecna fakultni nemocnice v Praze โ€” Prague,
  • Fakultni nemocnice Motol a Homolka โ€” Prague,
  • Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin โ€” Bordeaux,
  • Hospices Civils de Lyon Hopital Femme Mere Enfant โ€” Bron,
  • Hopital Necker Enfants Malades โ€” Paris,
  • Hopital Necker โ€” Paris,
  • Semmelweis Egyetem โ€” Budapest,
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar โ€” Szeged,
  • Uniwersyteckie Centrum Kliniczne โ€” Gdansk,

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—