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A Phase 2/3 Randomized Double‑Blind Study of Inebilizumab for Safety and Tolerability in Patients with Autoimmune Hepatitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Autoimmune Hepatitis is a rare condition in which the body’s immune system mistakenly attacks the liver, causing inflammation and damage. In this research, participants receive an intravenous infusion of a medication called inebilizumab, while other participants receive a matching infusion that does not contain the active drug.

The study’s goal is to see how safe and well‑tolerated the medication is for people with this liver disease. Participants are randomly assigned to one of the two groups, and neither the participants nor the study staff know which infusion is being given. Over a period of about six months, participants receive several infusions and have regular check‑ups to monitor liver function, side effects, and overall health. The trial ends after the final follow‑up visit, at which point the collected information is analyzed.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessments

    After joining the study, you will sign an informed consent form and undergo initial medical examinations.

    These examinations include blood tests, liver imaging, and a review of any current medications such as prednisone.

  2. Step 2

    Randomization to study medication

    The study team will assign you, by chance, to receive either inebilizumab or a placebo.

    You will not know which one you receive because the study is double‑blind.

  3. Step 3

    First intravenous infusion

    You will receive a single infusion through a vein (intravenous infusion).

    If assigned to the active group, the infusion contains 100 mg of inebilizumab dissolved in a solution for infusion.

    If assigned to the placebo group, the infusion contains an identical‑appearing solution without any active drug.

  4. Step 4

    Scheduled follow‑up infusions during the 26‑week treatment period

    Additional infusions will be given according to the study schedule throughout the first 26 weeks.

    Each infusion is administered intravenously and follows the same dosage as the first infusion.

  5. Step 5

    Regular laboratory monitoring

    At each study visit you will have blood drawn to check liver enzymes, especially ALT (alanine aminotransferase),

    The number of B cells in your blood, and the concentration of inebilizumab if you are in the active group.

  6. Step 6

    Assessment of prednisone dose

    Your prednisone (or equivalent steroid) dose will be reviewed at every visit to ensure it remains at or below 5 mg per day, as required by the study protocol.

  7. Step 7

    Safety monitoring for adverse events

    Throughout the 26‑week period you will be asked about any new symptoms or health problems.

    The study team will record any adverse events, serious adverse events, or events of special interest.

  8. Step 8

    Primary and secondary outcome evaluation at week 26

    At the end of week 26 a comprehensive assessment will be performed.

    The evaluation includes checking whether ALT has returned to normal, whether the modified histologic activity index (mHAI) is 3 or lower, and whether the prednisone dose is stable at 5 mg per day or less.

    Additional measurements such as B‑cell counts and drug levels (if applicable) will also be taken.

  9. Step 9

    Optional continuation into part 2 of the study

    Participants who meet specific criteria may be invited to continue in a second phase of the trial.

    This phase continues to monitor liver enzyme levels, steroid use, and safety for a longer period.

  10. Step 10

    Final study visit and completion

    After the designated treatment period (up to 78 weeks for some participants) a final visit will be scheduled.

    The visit includes a last set of blood tests, a review of any remaining adverse events, and collection of study data.

Who can join the trial?

7 criteria

  • Signed informed consent: You must sign a document that explains the study and shows you agree to take part.
  • Age between 18 and 75 years (or the legal adult age in your country, whichever is older) at the time you sign the consent form.
  • You must have had an inadequate response to at least nine months of standard treatment for autoimmune hepatitis, meaning your liver enzyme ALT (a blood test that shows liver damage) is still at least twice the normal upper limit (ULN) after taking standard medicines such as prednisone (a steroid), azathioprine (AZA), 6‑mercaptopurine (6‑MP), or mycophenolate mofetil (MMF). Alternatively, you may be unable to tolerate these medicines because side effects forced you to stop them or prevented you from reaching the needed dose.
  • Your liver enzyme ALT level at screening must be between 2 × ULN and 7 × ULN. This shows active disease but not an extreme level.
  • You need a liver biopsy that confirms autoimmune hepatitis with a diagnostic score of 7 or higher, performed within the 90 days before randomization, and the biopsy must show an mHAI score of at least 5 (a measure of inflammation severity).
  • Your medication doses must be stable: no increase in glucocorticoid (GC) dose (such as prednisone) during the 28 days before the baseline biopsy and through the day you are randomized; and you must have been on the highest tolerated dose of either AZA or 6‑MP or MMF/MPA for at least 12 weeks before screening and continue that stable dose unless safety reasons require a change.
  • You must use a reliable form of contraception (birth control) during the study treatment and for six months after the last dose of the study drug.

Who cannot join the trial?

44 criteria

  • Having another liver disease that overlaps with autoimmune hepatitis (for example, primary biliary cholangitis, primary sclerosing cholangitis, or lupus‑related liver disease) that meets specific overlap criteria.
  • Blood test results that are too low or too high, such as hemoglobin less than 7.5 g/dL (low red blood cells), neutrophils less than 1200 per mm³ (low white blood cells), platelets less than 150 × 10⁹/L, INR greater than 1.3 (a clotting test), CD19+ B cells less than 40 per µL, serum albumin less than 35 g/L, bilirubin above the normal range, alkaline phosphatase more than 1.5 times the upper limit, or AST more than 7 times the upper limit.
  • Having an active, serious infection at the time of enrollment.
  • Testing positive for HIV infection.
  • Having acute liver failure (sudden severe liver dysfunction with clotting problems or brain changes).
  • Being allergic to any part of the study drug inebilizumab or having had a severe allergic reaction (anaphylaxis) to similar treatments.
  • Being allergic to or unable to tolerate the medicines used to prevent infusion reactions (such as acetaminophen, diphenhydramine, or steroids).
  • Having an active cancer or a cancer that was treated within the past 10 years (with a few exceptions for certain skin, breast, prostate, or thyroid cancers that were cured long ago).
  • Having taken tumor‑necrosis‑factor (TNF) inhibitors (e.g., infliximab, adalimumab) within the last 6 months.
  • Having taken strong immune‑suppressing drugs like tacrolimus, cyclosporine, methotrexate, or everolimus within the last 6 weeks.
  • Having taken any other experimental drug within 12 weeks (or five half‑lives) before screening.
  • Having a known immune‑deficiency disorder.
  • Being unable to stop long‑term steroid (glucocorticoid) use because of adrenal insufficiency or other steroid‑dependent conditions.
  • Receiving any vaccine within 4 weeks before the first study dose.
  • Regularly using medicines that can damage the liver.
  • Having a current or past hepatitis B or hepatitis C infection, even if previously treated.
  • Currently taking high‑dose steroids (more than 20 mg prednisone per day) or high doses of certain immune‑suppressing pills (azathioprine, 6‑mercaptopurine, mycophenolate mofetil, or mycophenolic acid) above the listed limits.
  • Taking any other immune‑suppressing treatment besides the allowed ones (azathioprine, 6‑mercaptopurine, mycophenolate).
  • Having undetectable drug levels of azathioprine or mycophenolate during screening unless not taking those drugs.
  • Starting any new herbal or dietary supplement within 4 weeks before the first dose.
  • Currently participating in another clinical trial or having finished another trial less than 30 days (or five half‑lives) ago.
  • Being unable to safely have a liver biopsy.
  • Having metabolic‑associated steatohepatitis (MASH) identified on the liver biopsy.
  • Likely unable to complete all study visits and procedures.
  • Having any other serious medical condition that the doctor thinks makes participation unsafe.
  • Being pregnant, breastfeeding, or planning to become pregnant during the study period and for 6 months after the last dose.
  • Having a positive pregnancy test at screening.
  • Having active or untreated latent tuberculosis (TB) infection.
  • Unwilling to avoid donating blood or plasma while in the study.
  • Having uncontrolled alcohol use disorder (more than 2 drinks per day for men or 1 drink per day for women for at least 3 months).
  • Having had serious infections requiring hospitalization or IV antibiotics in the past year.
  • Having major surgery within 8 weeks before screening.
  • Having had two or more episodes of shingles (herpes zoster) or other serious opportunistic infections in the past year.
  • Having severe heart, lung, endocrine, gastrointestinal, blood, nervous system, psychiatric, or other systemic disease that puts you at high risk.
  • Experiencing any life‑threatening infection, sepsis, or fever with very low neutrophils.
  • Experiencing any serious allergic reaction or severe infusion‑related reaction during the study.
  • Having any grade 4 serious adverse event (the most severe type of side effect).
  • Having decompensated cirrhosis (advanced liver scarring with complications such as fluid buildup, confusion, bleeding, or kidney problems) or a history of such.
  • Having an absolute neutrophil count below 800 cells/µL confirmed by repeat testing.
  • Not following the study protocol well enough, as judged by the investigators.
  • Having a history of drug‑induced liver injury (DILI) from any medication.
  • Having received any B‑cell‑depleting biologic therapy (e.g., rituximab, ocrelizumab, inebilizumab) within the last 6 months.
  • Having received other biologic immune‑modulating drugs (e.g., belimumab, abatacept) within the last 6 months.
  • Having an estimated kidney filtration rate (eGFR) below 45 mL/min/1.73 m² (indicating reduced kidney function).
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Investigated drugs

Uplizna is a medication that contains a type of protein called a monoclonal antibody. It works by attaching to certain immune cells (called B‑cells) that can mistakenly attack the liver in autoimmune hepatitis. By reducing the activity of these cells, the drug may help calm the immune system and protect the liver. In the study, Uplizna is given through an IV (intravenous) infusion, and researchers are watching closely to see how safe it is and how well patients can tolerate it.

What is already known about the treatment

Uplizna - Uplizna is given by intravenous infusion, where the solution is slowly injected into a vein. It is an approved prescription drug that is also being studied in clinical research for autoimmune hepatitis. It works by attaching to a protein on certain immune cells called CD19, which reduces the activity of B‑cells that drive inflammation. It belongs to the class of monoclonal antibodies that target immune cells.

Investigated diseases

Autoimmune hepatitis - Autoimmune hepatitis is a chronic inflammatory liver disease in which the immune system mistakenly attacks liver cells. It often starts with mild fatigue, abdominal discomfort, and elevated liver enzymes. Over time, persistent inflammation can cause scarring (fibrosis) and may progress to cirrhosis. The condition frequently shows episodes of increased activity (flares) followed by periods of lower activity (remission). It is more common in women and may occur alongside other autoimmune disorders. Ongoing inflammation can gradually impair liver function if the disease remains active.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-522393-37-00Protocol code20240237Estimated enrolment180 patientsSponsorAmgen Inc.

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