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

🧪 Interventions in This Study

• Inebilizumab (DRUG)
• Placebo (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Signed informed consent.
2. Age ≥ 18 years or legal adult age within the country, whichever is older and \< 75 years at the time of signing the informed consent.
3. Participants must have either inadequate response to at least 9 months of SOC or are intolerant to SOC within 6 months of screening. Inadequate response to SOC treatment is defined as ALT ≥ 2 upper limit of normal (ULN) at screening after at least 9 months of SOC, including prednisone (or equivalent) \> 5 mg/day and at least one conventional steroid sparing agent at guideline-concordant target or highest appropriate dose, that is azathioprine (AZA) or 6-mercaptopurine (6-MP) at appropriate weight-based dosing (typically up to 2 mg/kg/day AZA or 1 mg/kg/day 6-MP) or mycophenolate (MMF) up to 2 g/day, as judged appropriate by the investigator and documented in the medical record. Intolerance to SOC treatment is defined as any clinically significant adverse event related to treatment that results in discontinuation of the medication or prevents dose optimization necessary to achieve or maintain biochemical response, as determined by the Principal Investigator (PI). Intolerance applies to GCs, AZA, 6-MP, or MMF. Presence of one or more clinically significant adverse effects attributed to SOC include but not limited to side effects that, in the opinion of the investigator, compromise participant's safety or quality of life, exacerbate comorbid conditions, or render continued use medically inappropriate.
4. Participants with disease activity at screening as follows: ALT ≥ 2 x ULN to ≤ 7 x ULN. ALT ULN values will be gender specific.
5. Participant must have a biopsy proven definitive diagnosis of AIH according to simplified diagnostic criteria (score ≥ 7). Liver biopsy should be obtained within 90 days prior to randomization. Participants must have a mHAI score ≥ 5 in the biopsy.
6. Participant should be on:
7. No increase in GC dose during the 28 days immediately preceding whichever biopsy is designated as the baseline sample-historical or screening-and the dose post biopsy must remain unchanged through the day of randomization AND
8. Stable maximum tolerated doses of AZA or 6-MP for at least 12 weeks prior to screening (baseline) liver biopsy until randomization and during the entire treatment period unless dose reduction is deemed necessary for safety or tolerance reasons OR
9. Stable maximum tolerated doses of MMF/mycophenolic acid (MPA) for at least 12 weeks prior to screening (baseline) liver biopsy until randomization and during the entire treatment period unless dose reduction is deemed necessary for safety or tolerance reasons.
10. Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (12 Sites)

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

📞 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.

More studies in Autoimmune Hepatitis

• Belimumab in Autoimmune Hepatitis — Calgary, Alberta
• A-LiNK: Improving Outcomes in Autoimmune Liver Disease — Palo Alto, California
• Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients — Indianapolis, Indiana

Explore by condition: All Autoimmune Hepatitis clinical trials

💡 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.