Health TrialsbyHealthPanel

A Trial of Inebilizumab in Participants With Autoimmune Hepatitis

ConditionsAutoimmune HepatitisAIH
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-74
SponsorAmgen

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Participants with disease activity at screening as follows: ALT ≥ 2 x ULN to ≤ 7 x ULN. ALT ULN values will be gender specific.

Disqualifiers

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.

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inebilizumab

    Drug

    Inebilizumab will be administered as an IV infusion.

  • Placebo

    Drug

    Placebo will be administered as IV infusion.

  • Standard of Care

    Other intervention

    Standard of Care

Treatment groups

180 Participants
are divided into 4 treatment groups
Group A: Part 1: InebilizumabExperimental treatment 2 interventions
Group B: Part 1: PlaceboExperimental treatment 2 interventions
Group C: Part 2: InebilizumabExperimental treatment 2 interventions
Group D: Part 2: PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
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.

Time frame
Week 78

Secondary outcomes

1

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

Time frame
Week 26
2

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

Time frame
Baseline and Week 26
3

Part 1: Maximum Serum Concentration (Cmax) of Inebilizumab

Time frame
Up to Week 26
4

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

Time frame
Up to Week 26

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: