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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04790916
Recruitment Status : Terminated (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.)
First Posted : March 10, 2021
Last Update Posted : December 3, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autoimmune Hepatitis Autoimmune Chronic Hepatitis Drug: RO7049665 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 19, 2021
Actual Primary Completion Date : November 18, 2021
Actual Study Completion Date : November 18, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RO7049665 3.5 mg
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.
 Drug: RO7049665
RO7049665, subcutaneous injection, Q2W.
Experimental: RO7049665 7.5 mg
Participants will receive RO7049665 7.5 mg, administered as SC injection, Q2W until participants experience relapse or the study is closed.
 Drug: RO7049665
RO7049665, subcutaneous injection, Q2W.
Placebo Comparator: Placebo
Participants will receive RO7049665-matching placebo, administered as SC injection, Q2W until participants experience relapse or the study is closed.
 Other: Placebo
RO7049665-matching placebo, subcutaneous injection, Q2W.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Change from Baseline in Alanine Aminotransferase (ALT) [ Time Frame: Up to end of the study (up to approximately 25 months) ]
  2. Change from Baseline in Aspartate Aminotransferase (AST) [ Time Frame: Up to end of the study (up to approximately 25 months) ]
  3. Change from Baseline in Immunoglobulin G (IgG) [ Time Frame: Up to end of the study (up to approximately 25 months) ]
  4. 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) ]
  5. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to end of the study (up to approximately 25 months) ]
  6. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04790916


Locations
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Australia, Victoria
The Alfred Hospital - Professor Stuart Roberts' Clinic - The Alfred Centre Location
Melbourne, Victoria, Australia, 3004
Canada, Quebec
Universite de Montreal - Centre Hospitalier de l'Universite de Montreal CHUM - Hopital Saint-Luc
Montreal, Quebec, Canada, H2X 0A9
Germany
Martin Zeitz Centrum für Seltene Erkrankungen ZSE Hamburg
Hamburg, Germany, 20246
Italy
Ospedale San Gerardo
Monza, Lombardia, Italy, 20900
IRCCS Saverio De Bellis; Anatomia Patologica
Castellana Grotte, Puglia, Italy, 70013
Korea, Republic of
Pusan National University Hospital; division of pulmonology
Busan, Korea, Republic of
Korea University Ansan Hospital
Gyeonggi-do, Korea, Republic of, 15355
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Liver Center
Seoul, Korea, Republic of, KOR
Netherlands
Amsterdam UMC - location AMC
Amstermdam, Netherlands, 1105 AZ
Radboud Universiteit - Radboud Universitair Medisch Centrum Radboudumc
Nijmegen, Netherlands, 6525 GA
Portugal
Centro Hospitalar de Vila Real
Vila Real, Portugal, 5000-508
United Kingdom
King College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04790916    
Other Study ID Numbers: BP42698
2020-003990-23 ( EudraCT Number )
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases