Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH)

• Register: ClinicalTrials.gov
• Last refreshed on: 6 December 2021
• Main ID: NCT04790916
• Date of registration: 08/03/2021
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH)
• Scientific title: A Double-Blind, Randomized, Parallel-Group, Phase 2 Study to Investigate the Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Patients With Autoimmune Hepatitis
• Date of first enrolment: April 19, 2021
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT04790916
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, Germany, Italy, Korea, Republic of, Netherlands, Portugal, United Kingdom

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Autoimmune Hepatitis

Autoimmune Chronic Hepatitis

Intervention(s)

Other: Placebo

Drug: RO7049665

Primary Outcome(s)

Time to Relapse for RO7049665 7.5 mg Versus Placebo [Time Frame: From randomization (Day 1) up to relapse or end of the study (up to approximately 25 months)]

Secondary Outcome(s)

Time to Relapse for RO7049665 3.5 mg Versus Placebo [Time Frame: From Randomization (Day 1) up to relapse or end of the study (up to approximately 25 months)]

Change from Baseline in Immunoglobulin G (IgG) [Time Frame: Up to end of the study (up to approximately 25 months)]

Percentage of Participants with Adverse Events (AEs) [Time Frame: Up to end of the study (up to approximately 25 months)]

Number of Participants with Anti-drug Antibody (ADA) Emergence and Neutralizing Potential [Time Frame: Up to end of the study (up to approximately 25 months)]

Change from Baseline in Aspartate Aminotransferase (AST) [Time Frame: Up to end of the study (up to approximately 25 months)]

Change from Baseline in Alanine Aminotransferase (ALT) [Time Frame: Up to end of the study (up to approximately 25 months)]

Secondary ID(s)

BP42698

2020-003990-23

Source(s) of Monetary Support

Please refer to primary and secondary sponsors