Brief Title
Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH)
Official 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
Brief Summary
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Time to Relapse for RO7049665 7.5 mg Versus Placebo
Secondary Outcome
Change from Baseline in Alanine Aminotransferase (ALT)
Condition
Autoimmune Hepatitis
Intervention
RO7049665
Study Arms / Comparison Groups
RO7049665 3.5 mg
Description: Participants will receive RO7049665 3.5 mg, administered as subcutaneous (SC) injection, every 2 weeks (Q2W) until participants experience relapse or the study is closed.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
2
Start Date
April 19, 2021
Completion Date
November 18, 2021
Primary Completion Date
November 18, 2021
Eligibility 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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Clinical Trials, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT04790916
Organization ID
BP42698
Secondary IDs
2020-003990-23
Responsible Party
Sponsor
Study Sponsor
Hoffmann-La Roche
Study Sponsor
Clinical Trials, Study Director, Hoffmann-La Roche
Verification Date
November 2021