AzTrials
AzTrials

Autoimmune HepatitisPhase 3MERCURYNCT07598825

A Trial of Inebilizumab in Participants With Autoimmune Hepatitis

A Phase 3 study testing Inebilizumab in people with Autoimmune Hepatitis and AIH, run by Amgen at 36 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Autoimmune Hepatitis, AIH
What is being tested?
Inebilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
36 sitesin 8 countries
Study dates
18 Dec 2026to 11 Feb 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent.
  • Age ≥ 18 years or legal adult age within the country, whichever is older and < 75 years at the time of signing the informed consent.
  • 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.
  • Participants with disease activity at screening as follows: ALT ≥ 2 x ULN to ≤ 7 x ULN. ALT ULN values will be gender specific.
  • 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.
Show all 11Show fewer
  • Participant should be on:
  • 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
  • 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
  • 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.
  • Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention.

Who cannot join

  • Diagnosis of definitive overlap autoimmune liver or rheumatologic syndrome with autoimmune hepatitis (eg, AIH + primary biliary cholangitis [PBC], AIH + primary sclerosing cholangitis [PSC], AIH related to Systemic Lupus Erythematosus, etc) where established overlap criteria are met.
  • Acute liver failure (ALF) at screening (e.g., acute hepatic dysfunction with coagulopathy and any degree of encephalopathy) in the investigator's judgment.
  • Participant has known history of:
  • Allergy or reaction to any component of inebilizumab formulation or history of anaphylaxis to any human gamma globulin therapy.
  • Allergy to or intolerance of protocol-required treatment, including medications for prophylaxis of infusion reactions (antipyretic such as paracetamol/acetaminophen or equivalent, diphenhydramine or equivalent, and methylprednisolone or equivalent).
  • Active malignancy or history of malignancy that was active within the last 10 years, except as follows:
Show all 84Show fewer
  • In situ carcinoma of the cervix treated with apparent success with curative therapy for > 12 months prior to screening
  • Curatively treated breast ductal carcinoma in situ
  • Cutaneous basal cell or squamous cell carcinoma treated with apparent success with curative therapy for > 12 months prior to screening
  • Prostate cancer treated with radical prostatectomy or radiation therapy with curative intent > 3 years prior to screening and without known recurrence or current treatment
  • Thyroid cancer for which complete surgical resection has been performed within 5 years with well-differentiated histology (papillary thyroid carcinoma or follicular thyroid carcinoma) and there is no evidence of active disease.
  • Known positive test for human immunodeficiency virus (HIV) infection. Evidence of HIV infection or positive for HIV antibodies at initial screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.
  • Presence or history of viral hepatitis infection:
  • Positive test for, or prior treatment for, hepatitis B. A positive test for hepatitis B is detection of either:
  • Positive for hepatitis B surface antigen (HBsAg) OR
  • anti-HBc
  • Participants with a history of or current hepatitis C virus (HCV) infection, even those considered to be cured.
  • Active tuberculosis (TB) or latent TB with no documented history of adequate treatment per local SOC.
  • Positive test for TB during screening is defined as positive QuantiFERON® test. At screening, all participants must be tested with an interferon-γ release assay (IGRA) (QuantiFERON®).
  • History of > 1 episode of herpes zoster (any grade) and/or any other definite or probable opportunistic infection in the 12 months prior to screening.
  • Estimated glomerular filtration rate < 45 mL/min/1.73 m^2 using chronic kidney disease epidemiology (CKD-EPI) 2021 formula.
  • Blood tests at screening that meet any of the following criteria:
  • Hemoglobin < 7.5 g/dL
  • Neutrophils < 1200/mm^3
  • Platelets < 150 x 10^9/L
  • international normalized ratio (INR) > 1.3
  • cluster of differentiation 19 (CD19)+ B cells at screen < 40 cells/µL; an exclusionary value may be repeated.
  • Serum albumin level < 35 g/L
  • Direct bilirubin (BIL) in serum >ULN
  • Total BIL ≥ 2.0 mg/dL
  • ALP > 1.5 x ULN
  • AST > 7 x ULN Note: Participants with baseline cytopenia (where permitted) may be enrolled if, in the Investigator's judgment, the cytopenia derives from an alternative to AIH condition (eg, medication effect, nutritional deficiency, anemia of chronic disease etc).
  • Active, clinically significant infection at the time of randomization (investigational product administration may be delayed until recovery, if within screening window, otherwise participant may be rescreened).
  • History or evidence of uncontrolled alcohol use disorder (AUD), defined as participants who have a history of significant alcohol consumption, ie, consumption of >2 units/day for males and >1 unit/day for females, sustained for ≥ 3 consecutive months.
  • History of recurrent significant infections (eg, requiring hospitalization or IV antibiotics) within the past 12 months.
  • Major surgery within 8 weeks before screening.
  • Severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder, or any other condition that, in the opinion of the Investigator, would place the participant at unacceptable risk of complications, interfere with evaluation of the Investigational product or confound the interpretation of participant safety or trial results.
  • Known immunodeficiency disorder.
  • Participants with moderate-to-severe metabolic dysfunction-associated steatohepatitis (MASH) on screening/baseline liver biopsy, defined by central pathology review as steatosis grade ≥ 2 with lobular inflammation ≥ 1, and hepatocellular ballooning ≥ 1.
  • Participants with decompensated cirrhosis, either historical or present at screening defined by:
  • Histologic cirrhosis on screening or prior liver biopsy (fibrosis stage F4 / Ishak 5-6), and
  • Prior hepatic decompensation or Child-Pugh B-C.
  • Child-Pugh category A at screening, without a history of prior hepatic decompensation (ascites, encephalopathy, variceal bleeding, spontaneous bacterial peritonitis [SBP], hepatorenal syndrome [HRS], acute-on-chronic liver failure, or progression to decompensated cirrhosis), is eligible.
  • Participant with a history of drug-induced liver injury (DILI), regardless of offending agent.
  • Receipt of any biologic B cell-depleting therapy (eg, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab, ianalumab) in the 6 months prior to screening.
  • Receipt of non-depleting B cell-directed therapy (eg, belimumab), abatacept, or other biologic immunomodulatory agent within 6 months prior screening.
  • Receipt of tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab) within 6 months prior screening.
  • Receipt of immunosuppressive agents such as calcineurin inhibitors (tacrolimus, cyclosporin except eye drops), methotrexate, mammalian target of rapamycin inhibitors (eg, everolimus) within 6 weeks prior screening.
  • Receipt of any investigational agent < 12 weeks or < 5 half-lives of the drug (whichever is longer) prior to screening.
  • History of inability to be tapered off of GC therapy due to adrenal insufficiency or due to recurrent or prolonged systemic glucocorticoid therapy for any medical condition other than AIH (eg, severe steroid-dependent asthma) according to PI.
  • All vaccines are prohibited within 4 weeks before the first dose of trial treatment.
  • Participants are recommended to be administered vaccines at least 4 weeks prior to dosing in accordance with local recommendations prior to enrollment to allow for adequate immune response.
  • Required regular use of medications with known hepatotoxicity.
  • Current use of:
  • GCs (prednisone > 20 mg/day, or equivalent dose of other GCs)
  • AZA > 2 mg/kg/day
  • 6-MP > 1 mg/kg/day
  • MMF > 2 g/day or MPA > 1440 mg/day.
  • Any concomitant immunosuppressive treatment, alone or in combination with GCs, except for AZA, 6-MP, MMF, and MPA.
  • Undetectable levels of 6-thioguanine nucleotides (6-TGN) or MPA during screening unless participants are not on AZA or MMF/MPA due to intolerance per protocol.
  • No new Herbal and Dietary Supplements (HDS) products for 4 weeks prior to first dose of inebilizumab.
  • Currently receiving a trial intervention, or less than 30 days or 5 half-lives if known (whichever is later) since ending a trial intervention in another investigational device or drug trial.
  • Unable to safely undergo a liver biopsy.
  • Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.
  • History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.
  • Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or planning to become pregnant, donate eggs, or breastfeed while on trial until an additional 6 months after the last dose of inebilizumab (if applicable) with highest teratogenic risk.
  • Participants of childbearing potential with a positive pregnancy test assessed by serum pregnancy test at screening and a urine pregnancy test at Day 1 visit.
  • Participant unwilling to abstain from donating blood or plasma during the trial.
  • In order for participants to continue to OLP, they must:
  • Have completed the randomized controlled treatment period Week 78 visit and received all doses or not discontinued investigational product for any of the following reasons:
  • Anaphylaxis or a serious hypersensitivity reaction that occurred within 7 days after IV dosing and cannot be attributed to another known allergen exposure.
  • Any adverse events or significant laboratory abnormality that, in the opinion of the investigator, Amgen, or Data Monitoring Committee (DMC), warrants discontinuation of dosing.
  • Any life-threatening (grade 4) infection.
  • Any event of sepsis or febrile neutropenia.
  • Any infection listed as either a definite or probable opportunistic infection.
  • Any grade 3 infusion related reactions (IRR).
  • Any grade 4 serious adverse events.
  • Pregnancy or a decision to become pregnant.
  • Malignancy.
  • Absolute neutrophil count < 800 cells/µL confirmed by repeat testing.
  • Determination that the participant was ineligible for trial participation and continuation of investigational product could pose a safety risk to the participant in the judgment of the investigator or the sponsor.
  • Significant noncompliance with the trial protocol, as judged by the investigator or Amgen.
  • Receive dose 1 in the OLP within the window of 7 days after the randomized controlled treatment period Week 78 visit and only after the Week 78 biopsy has been completed.
  • Participants who meet protocol-defined early escape criteria and discontinue the RCP may enter the OLP, provided they have not discontinued investigational product for safety-related reasons that preclude further dosing.

Trial locations and contacts

36 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Amgen Call Center contact

866-572-6436

medinfo@amgen.com

36 sites in 8 countries

China17 sites, 17 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Recruiting

  • Beijing Youan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100069

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Recruiting

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

    Recruiting

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610044

    Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

    Recruiting

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350025

    Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

    Recruiting

  • The Second Hospital of Nanjing

    Nanjing, Jiangsu, 210003

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

    Recruiting

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200001

    Recruiting

  • The Fifth Peoples Hospital of Suzhou

    Suzhou, Jiangsu, 215131

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

    Recruiting

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300384

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Recruiting

Other trials in China

United States12 sites, 11 recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Recruiting

  • Methodist Cardiovascular Consultants - Dallas

    Dallas, Texas, 75203

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

    Recruiting

  • Florida Research Institute

    Largo, Florida, 33771

    Recruiting

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72205

    Recruiting

  • Floridian Clinical Research LLC

    Miami Lakes, Florida, 33016

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Inland Empire Liver Foundation

    Rialto, California, 92377

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Recruiting

  • American Research Corporation

    San Antonio, Texas, 78215

    Recruiting

  • Amicis Research Center

    Valencia, California, 91355

    Terminated

Other trials in United States

Canada2 sites, 2 recruiting

  • Centre de Recherche du Centre Hospitalier de l Universite de Montreal

    Montreal, Quebec, H2X 0A9

    Recruiting

  • McGIll University Health Centre Glen Site

    Montreal, Quebec, H4A 3J1

    Recruiting

Other trials in Canada

Belgium1 site, 1 recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

Other trials in Belgium

France1 site, 1 recruiting

  • Hôpital Saint Antoine

    Paris, 75012

    Recruiting

Other trials in France

Germany1 site, 1 recruiting

  • Universitaetsklinikum Jena

    Jena, 07747

    Recruiting

Other trials in Germany

Hungary1 site, 1 recruiting

  • Obudai Egeszsegugyi Centrum Kft

    Zalaegerszeg, 8900

    Recruiting

Other trials in Hungary

Italy1 site, 1 recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

Other trials in Italy

About this study

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

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).

Read the detailed description

This study will consist of a screening period (up to 56 days), a randomized controlled treatment period (78 weeks), an optional open label period (OLP) up to 78 weeks (or until potential availability of the marketed drug) for eligible participants who complete the treatment period, and a safety follow-up (SFU) period up to 78 weeks.

The randomized controlled treatment period will be divided in 2 parts, a phase 2 dose confirmation and safety part (Part 1) and an efficacy evaluating phase 3 (Part 2). Part 1 will conclude when the last Part 1 participant has had the opportunity to complete the Week 26 visit. Part 2 will begin without pausing enrollment; the same randomization ratio and study procedures are maintained.

Being tested
Inebilizumab, Placebo, Standard of Care
Keywords
Autoimmune hepatitis, AIH, Inebilizumab, AMG 335
Medical subject headings
Hepatitis, Autoimmune

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InebilizumabDrug

    Also called AMG 335

    Inebilizumab will be administered as an IV infusion.

  • PlaceboDrug

    Placebo will be administered as IV infusion.

  • Standard of CareOther

    Standard of Care

Study groups in NCT07598825
Study groupRoleWhat they receive
Part 1: InebilizumabExperimentalParticipants will receive inebilizumab as an intravenous (IV) infusion in addition to standard of care (SOC).
Receives: Drug: Inebilizumab; Other: Standard of Care
Part 1: PlaceboExperimentalParticipants will receive placebo as an IV infusion in addition to SOC.
Receives: Drug: Placebo; Other: Standard of Care
Part 2: InebilizumabExperimentalParticipants will receive Inebilizumab as an IV infusion in addition to SOC.
Receives: Drug: Inebilizumab; Other: Standard of Care
Part 2: PlaceboExperimentalParticipants will receive placebo as an IV infusion in addition to SOC.
Receives: Drug: Placebo; Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Interest at Week 26

    Measured: Up to Week 26

  2. Part 2: Number of Participants who Achieved Modified Histologic Activity Index (mHAI) ≤ 3 and Stable Prednisone Dose (or equivalent) ≤ 5 mg/day at Week 78

    Participants who met the two outcomes combined will be reported for this endpoint.

    Measured: Week 78

Secondary outcomes (23)

  1. Part 1: Number of Participants who Achieved Normal Alanine Aminotransferase (ALT) Levels at Week 26

    Measured: Week 26

  2. Part 1: Change from Baseline in ALT Levels at Week 26

    Measured: Baseline and Week 26

  3. Part 1: Maximum Serum Concentration (Cmax) of Inebilizumab

    Measured: Up to Week 26

  4. Part 1: Area Under the Serum Concentration-time Curve (AUC) of Inebilizumab

    Measured: Up to Week 26

  5. Part 1: Change from Baseline in Peripheral B Cell Counts at Week 26

    Measured: Baseline and Week 26

  6. Part 2: Number of Participants who Achieved Sustained Normal ALT Levels and Stable Prednisone Dose (or equivalent) ≤ 5 mg/day by Week 78

    Sustained normal ALT levels is defined as achieving normal ALT levels in the 3 consecutive visits.

    Participants who met the two outcomes combined will be reported for this endpoint.

    Measured: Week 78

  7. Part 2: Number of Participants who Achieved Normal ALT Levels, mHAI ≤ 3 and Stable Prednisone Dose (or equivalent) ≤ 5 mg/day at Week 78

    Participants who met the three outcomes combined will be reported for this endpoint.

    Measured: Week 78

  8. Part 2: Number of Participants who Achieved Stable Prednisone Dose (or equivalent) ≤ 5 mg/day by Week 78

    Measured: Week 78

  9. Part 2: Number of Participants who Achieved Normal ALT Levels and Stable Glucocorticoid (GC) Free (0 mg) by Week 78

    Participants who met the two outcomes combined will be reported for this endpoint.

    Measured: Week 78

  10. Part 2: Time to Persistently Achieve Normal ALT Levels and Stable Prednisone (or equivalent) ≤ 5 mg/day Through Week 78

    Time to achieve normal ALT levels is defined as as the first occurrence of normal ALT levels in at least 2 consecutive visits through Week 78.

    Participants who met the two outcomes combined will be reported for this endpoint.

    Measured: Up to Week 78

  11. Part 2: Change from Baseline in ALT Levels at Week 78

    Measured: Baseline and Week 78

  12. Part 2: Change from Baseline in Immunoglobulin G (IgG) Levels at Week 78

    Measured: Baseline and Week 78

  13. Part 2: Change from Baseline in Aspartate Aminotransferase (AST) Levels at Week 78

    Measured: Baseline and Week 78

  14. Part 2: Change from Baseline in mHAI at Week 78

    Measured: Baseline and Week 78

  15. Part 2: Number of Participants who Achieved Normal ALT and IgG Levels at Week 78

    Participants who met the two outcomes combined will be reported for this endpoint.

    Measured: Week 78

  16. Part 2: Number of Participants who Achieved mHAI ≤ 3 at Week 78

    Measured: Week 78

  17. Part 2: Number of Participants who Achieved Flare-free, Stable GC-free (0 mg) Normalization of ALT by Week 78

    Measured: Week 78

  18. Part 2: Cumulative GC Dose per Participant for AIH

    Measured: Up to Week 78

  19. Part 2: Number of Participants with Anti-drug Antibodies (ADA)

    Measured: Up to Week 78

  20. Part 2: Cmax of Inebilizumab

    Measured: Up to Week 78

  21. Part 2: AUC of Inebilizumab

    Measured: Up to Week 78

  22. Part 2: Number of Participants who Experienced TEAEs, Serious TEAEs, and TEAEs of Interest

    Measured: Up to Week 78

  23. Part 2: Change from Baseline of GC Toxicity Index Score at Week 78

    Measured: Baseline and Week 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2026
  2. Study start18 Dec 2026 (estimated)
  3. Primary completion30 Jul 2031 (estimated)
  4. Study completion11 Feb 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07598825
Sponsor's protocol ID
20240237
Other IDs
2025-522393-37-00, 2025
Acronym
MERCURY
Status last verified
Nov 2026
First submitted
14 May 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inebilizumab in people with Autoimmune Hepatitis and AIH, run by Amgen at 36 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 84 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in China, United States, Canada, Belgium, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Interest at Week 26 (time frame: Up to Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07598825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in