๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-12

A Trial of Inebilizumab in Participants With Autoimmune Hepatitis (NCT07598825)

A Phase 2/3, Randomized, Double-blind, Multicenter, Placebo-controlled Study of Inebilizumab in Participants With Autoimmune Hepatitis

๐ŸŸก Not Yet Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Amgen

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

The main objectives of this trial are to evaluate the safety and tolerability of inebilizumab in participants with autoimmune hepatitis (AIH) (Part 1) and to evaluate the efficacy of inebilizumab on AIH disease activity and glucocorticoid (GC) use in the management of AIH (Part 2).

Who can join: Review the eligibility criteria below.

Location: Applied Research Center of Arkansas โ€” Little Rock, Arkansas

Age range: 18 Years to 74 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 (12 Sites)

  • Applied Research Center of Arkansas โ€” Little Rock, Arkansas
  • Amicis Research Center โ€” Northridge, California
  • Inland Empire Liver Foundation โ€” Rialto, California
  • Indiana University โ€” Indianapolis, Indiana
  • Methodist Cardiovascular Consultants - Dallas โ€” Dallas, Texas
  • American Research Corporation โ€” San Antonio, Texas
  • The Second Hospital of Anhui Medical University โ€” Hefei, Anhui
  • Peking University First Hospital โ€” Beijing, Beijing Municipality
  • Beijing Friendship Hospital, Capital Medical University โ€” Beijing, Beijing Municipality
  • Peking Union Medical College Hospital โ€” Beijing, Beijing Municipality
  • The First Affiliated Hospital of Zhengzhou University โ€” Zhengzhou, Henan
  • Renji Hospital Shanghai Jiaotong University School of Medicine โ€” Shanghai, Shanghai Municipality

๐Ÿ“ž 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.

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.

More studies in Autoimmune Hepatitis

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  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†—