Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD (NCT07222553)
Open-label, Uncontrolled, Multicenter Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Immunoglobulin G4-related Disease (IgG4-RD)
🩺 Plain-English Summary (8th-Grade Level)
The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD), as well as to assess the safety and tolerability, of inebilizumab in pediatric participants with IgG4-RD.
Who can join: Review the eligibility criteria below.
Location: University of South Florida - Carol and Frank Morsani Center for Advanced Health Care — Tampa, Florida
Age range: 2 Years to 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- University of South Florida - Carol and Frank Morsani Center for Advanced Health Care — Tampa, Florida
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
- University of Pittsburgh Medical Center Childrens Hospital of Pittsburgh — Pittsburgh, Pennsylvania
- Centro Oncologia Leonardo Da Vinci — Fortaleza, Ceará
- Peking Union Medical College Hospital — Beijing, Beijing Municipality
- The Second Xiangya Hospital of Central South University — Changsha, Hunan
- Euroclinic Children Hospital — Athens,
- General Children Hospital Panagioti and Aglaias Kyriakou — Athens,
- Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher — Warsaw,
- Instytut Pomnik-Centrum Zdrowia Dziecka — Warsaw,
- Hospital Universitari i Politecnic La Fe — Valencia, Valencia
- Hacettepe Universitesi Tip Fakultesi Hastanesi — Ankara,
- Istanbul Universitesi Cerrahpasa Tip Fakultesi — Istanbul,
- Umraniye Egitim ve Arastirma Hastanesi — Istanbul,
📞 Contact the Study Coordinator
Phone: (866) 572-6436
Email: medinfo@amgen.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 § 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.
Explore by condition: All Immunoglobulin G4-related Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.