MERCURY Clinical Study for AIH| PatientWing

The MERCURY Study

The purpose of the MERCURY study is to evaluate a study drug for autoimmune hepatitis (AIH). The study aims to assess the safety and efficacy of a study drug in adults who are unable to tolerate or have not responded to the standard of care for AIH.

Participants must meet the following criteria:

Between the ages of 18 and 75 years old

Either inadequate response to at least 9 months of standard-of-care (SOC) or are intolerant to SOC within 6 months of screening  

“Inadequate response” is defined as an ALT≥ 2 x ULN at screening after at least 9 months of standard of care, including prednisone or equivalent and at least one steroid-sparing agent 

“Intolerance” is defined as any adverse event related to SOC that results in discontinuation of medication or prevents determination of dose optimization 

Biopsy proven diagnosis of autoimmune hepatitis

Biopsy should be obtained within 90 days prior to randomization 

Currently taking:

No increase in glucocorticoids in 28 days prior to biopsy or screening through randomization and stable maximum tolerated doses of AZA or 6-MP for at least 12 weeks prior to screening liver biopsy through the entire treatment period OR 

Stable maximum dose of MMF/MPA for at least 12 weeks prior to screening liver biopsy through the entire treatment period  

Participants are not eligible if they have:

A diagnosis of overlapping autoimmune liver or rheumatologic syndrome with AIH 

History of anaphylaxis to any human gamma globulin or other protocol-required treatment 

A historical diagnosis of metabolic dysfunction-associated steatohepatitis (MASH) or MASH diagnosed on liver biopsy 

Cirrhosis and ongoing significant impairment of liver function 

A history of drug related liver injury 

Any concomitant immunosuppressive treatments that are not the eligible medications 

Other eligibility criteria apply and will be evaluated by a principal investigator.  

Participants are randomized into study drug or placebo groups. There is a 50% chance of receiving the placebo, but there is an optional  open-label period at the completion of the treatment period. 

What the MERCURY Study Offers

Current treatment options for AIH are limited. They may not result in lasting remissions and may cause adverse events that prevent continued treatment. The MERCURY Study looks to evaluate the safety and efficacy of a study drug, including whether it may help control liver inflammation and control the long-term reliance on corticosteroids in adult AIH patients.

By enrolling in this study, patients may receive: 

The study drug at no cost to them

Both groups continue to receive background therapies for their AIH in addition to the study drug.  

Reasonable reimbursement for travel expenses may be available.  

Submit Referral

Participants Should Expect:  

Randomization to receive either the study drug or placebo. There is a 50% chance of receiving the placebo. 

Eligible participants who complete the treatment period will have the option to join the open-label period and receive the study drug.

Visits with the study team about 36 times over the course of up to 38 months, depending on whether they participate in the optional open-label period.  

There may be opportunities for home health visits during the treatment period.

Study drug and placebo is delivered 3 times during the treatment period and the study drug is delivered an additional 5 times if participating in the open-label period.