A lack of efficacy was seen with RO7049665 in a study of ulcerative colitis. This reduces the likelihood that the drug is effective in autoimmune hepatitis.

The primary objective of the study is to evaluate the effect of RO7049665 on time to relapse following forced corticosteroid (CCS) tapering as measured by the hazard ratio between RO7049665 7.5 milligrams (mg) and placebo arm.

Inclusion Criteria:

• Participants with a definite diagnosis of AIH (type 1, 2 and 3) as per simplified or revised original diagnostic criteria
• Participants who have been in biochemical remission for > 2 years (or less if according to the local practice) prior to randomization
• Participants who have been on stable treatment (corticosteroids [CCSs] +/- non-specific immunosuppressants [NSIs]) for at least 3 months prior to randomization and who have not had a dose increase in the previous 6 months prior to randomization
• No signs of liver inflammation on a liver biopsy taken no more than 12 months prior to randomization
• Participants with AIH who have previously not attempted (or not attempted in the last 3 years, if this is the local practice) to taper CCSs to 0 mg/day
• Body mass index within the range of 18-35 kilograms per meter square (kg/m^2)
• Women of childbearing potential who agree to remain abstinent or use at least one acceptable contraceptive method during the treatment period and for at least 28 days after the final dose of study drug

Exclusion Criteria:

• Participants with cirrhosis (F4 fibrosis by Fibroscan®) with significant impairment of liver function (Child Pugh category B or C)
• Any other autoimmune disease requiring immunomodulating treatment
• History of infection with hepatitis B, human immunodeficiency virus, active hepatitis C virus (HCV) infection, detection of replicating cytomegalovirus (CMV) or Epstein-Barr virus (EBV)
• Active infections requiring systemic therapy with antibiotic, antiviral, or antifungal treatment or febrile illness within 7 days before Day-1
• History of primary or acquired immunodeficiency
• Pregnant or lactating female participants
• Symptomatic herpes zoster within 3 months prior to screening
• History of active or latent tuberculosis or a positive Quantiferon Gold test
• History of clinically significant severe drug allergies, multiple drug allergies, allergy to any constituent of the product, or intolerance to topical steroids
• Lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years and in situ carcinoma of the cervix that was completely removed surgically. Breast cancer within the past 10 years
• Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
• Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the study in the opinion of the Investigator
• CCSs of <5 mg/day, or <2.5 mg CCSs plus immune suppressant, or <3 mg/day budesonide with or without immune suppressant
• CCSs >20 mg/day or >9 mg/day budesonide
• Non-specific immunosuppressant (NSI) daily dose higher than recommended standard of care therapy
• T or B cell-depleting therapy within the last 12 months or T- or B-cell number below normal due to depleting therapy
• Leukocyte apheresis within 12 weeks of screening
• Donation of blood or blood products in excess of 500 milliliters (mL) within 3 months prior to screening.
• Exposure to any investigational treatment within 6 months prior to Day 1
• Abnormal hematologic, hepatic enzyme, hepatic function, or biochemistry values

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.