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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04790916




Registration number
NCT04790916
Ethics application status
Date submitted
8/03/2021
Date registered
10/03/2021

Titles & IDs
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
Secondary ID [1] 0 0
2020-003990-23
Secondary ID [2] 0 0
BP42698
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autoimmune Hepatitis 0 0
Autoimmune Chronic Hepatitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RO7049665
Other interventions - Placebo

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.

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.

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


Treatment: Drugs: RO7049665
RO7049665, subcutaneous injection, Q2W.

Other interventions: Placebo
RO7049665-matching placebo, subcutaneous injection, Q2W.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Relapse for RO7049665 7.5 mg Versus Placebo
Timepoint [1] 0 0
From randomization (Day 1) up to relapse or end of the study (up to approximately 25 months)
Secondary outcome [1] 0 0
Change From Baseline in Alanine Aminotransferase (ALT)
Timepoint [1] 0 0
Up to end of the study (up to approximately 25 months)
Secondary outcome [2] 0 0
Change From Baseline in Aspartate Aminotransferase (AST)
Timepoint [2] 0 0
Up to end of the study (up to approximately 25 months)
Secondary outcome [3] 0 0
Change From Baseline in Immunoglobulin G (IgG)
Timepoint [3] 0 0
Up to end of the study (up to approximately 25 months)
Secondary outcome [4] 0 0
Time to Relapse for RO7049665 3.5 mg Versus Placebo
Timepoint [4] 0 0
From Randomization (Day 1) up to relapse or end of the study (up to approximately 25 months)
Secondary outcome [5] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [5] 0 0
Up to end of the study (up to approximately 25 months)
Secondary outcome [6] 0 0
Number of Participants With Anti-drug Antibody (ADA) Emergence and Neutralizing Potential
Timepoint [6] 0 0
Up to end of the study (up to approximately 25 months)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/11/2021
Sample size
Target
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Professor Stuart Roberts' Clinic - The Alfred Centre Location - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
Germany
State/province [3] 0 0
Hamburg
Country [4] 0 0
Italy
State/province [4] 0 0
Lombardia
Country [5] 0 0
Italy
State/province [5] 0 0
Puglia
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Busan
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Gyeonggi-do
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
Netherlands
State/province [9] 0 0
Amstermdam
Country [10] 0 0
Netherlands
State/province [10] 0 0
Nijmegen
Country [11] 0 0
Portugal
State/province [11] 0 0
Vila Real
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04790916