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

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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