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

NCT04790916 | Terminated Phase 2 Results DMC

• 2 other identifiers: BP426982020-003990-23
• Study Type: interventional
• Target: 2
• Locations: 8 countries
• Sites: 14

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.

Conditions

Autoimmune Hepatitis; Autoimmune Chronic Hepatitis

Outcome Measures

Primary Outcomes (1)

• Time to Relapse for RO7049665 7.5 mg Versus Placebo

  The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

  From randomization (Day 1) up to relapse or end of the study (up to approximately 25 months)

Secondary Outcomes (6)

• Change From Baseline in Alanine Aminotransferase (ALT)

  Up to end of the study (up to approximately 25 months)

• Change From Baseline in Aspartate Aminotransferase (AST)

  Up to end of the study (up to approximately 25 months)

• Change From Baseline in Immunoglobulin G (IgG)

  Up to end of the study (up to approximately 25 months)

• Time to Relapse for RO7049665 3.5 mg Versus Placebo

  From Randomization (Day 1) up to relapse or end of the study (up to approximately 25 months)

• Percentage of Participants With Adverse Events (AEs)

  Up to end of the study (up to approximately 25 months)

Study Arms (3)

RO7049665 3.5 mg

EXPERIMENTAL

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 7.5 mg

EXPERIMENTAL

Participants will receive RO7049665 7.5 mg, administered as SC injection, Q2W until participants experience relapse or the study is closed.

Drug: RO7049665

Placebo

PLACEBO COMPARATOR

Participants will receive RO7049665-matching placebo, administered as SC injection, Q2W until participants experience relapse or the study is closed.

Other: Placebo

Interventions

RO7049665 DRUG

RO7049665, subcutaneous injection, Q2W.

RO7049665 3.5 mg; RO7049665 7.5 mg

Placebo OTHER

RO7049665-matching placebo, subcutaneous injection, Q2W.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (14)

The Alfred Hospital - Professor Stuart Roberts' Clinic - The Alfred Centre Location

Melbourne, Victoria, 3004, Australia

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Universite de Montreal - Centre Hospitalier de l'Universite de Montreal CHUM - Hopital Saint-Luc

Montreal, Quebec, H2X 0A9, Canada

Location

Martin Zeitz Centrum für Seltene Erkrankungen ZSE Hamburg

Hamburg, 20246, Germany

Location

IRCCS Saverio De Bellis; Anatomia Patologica

Castellana Grotte, Apulia, 70013, Italy

Location

Ospedale San Gerardo

Monza, Lombardy, 20900, Italy

Location

Amsterdam UMC - location AMC

Amstermdam, 1105 AZ, Netherlands

Location

Radboud Universiteit - Radboud Universitair Medisch Centrum Radboudumc

Nijmegen, 6525 GA, Netherlands

Location

Centro Hospitalar de Vila Real

Vila Real, 5000-508, Portugal

Location

Pusan National University Hospital; division of pulmonology

Busan, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, 15355, South Korea

Location

University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Liver Center

Seoul, KOR, South Korea

Location

King College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Nottingham University Hospitals NHS Trust - City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis, Autoimmune

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 10, 2021
• Study Start: April 19, 2021
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: September 18, 2023
• Results First Posted: September 18, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

PT (1); DE (1); KR (3); CA (2); AU (1); IT (2); NL (2); GB (2)