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
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ 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.
๐ฐ 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
- Belimumab in Autoimmune Hepatitis โ Calgary, Alberta
- A-LiNK: Improving Outcomes in Autoimmune Liver Disease โ Palo Alto, California
- Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients โ Indianapolis, Indiana
Explore by condition: All Autoimmune Hepatitis clinical trials
๐ก 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.