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    Summary
    EudraCT Number:2020-003990-23
    Sponsor's Protocol Code Number:BP42698
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-003990-23
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Patients With Autoimmune Hepatitis
    A.4.1Sponsor's protocol code numberBP42698
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffman-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIgG IL2/RO7049665
    D.3.2Product code RO7049665
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number 2056881-92-4
    D.3.9.2Current sponsor codeRO7049665
    D.3.9.3Other descriptive nameRO7049665/IgG-IL2/ IgG-IL2ND2
    D.3.9.4EV Substance CodeSUB187103
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autoimmune Hepatitis (AIH)
    Autoimmune Hepatitis (AIH)
    E.1.1.1Medical condition in easily understood language
    AIH is a chronic disease in which your body's immune system attacks the liver and causes inflammation and liver damage
    AIH is a chronic disease in which your body's immune system attacks the liver and causes inflammation and liver damage
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10003827
    E.1.2Term Autoimmune hepatitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    AIH is a chronic disease in which your body's immune system attacks the liver and causes inflammation and liver damage
    E.2.2Secondary objectives of the trial
    •To assess changes in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and IgG over time and by dose
    •To evaluate the effect of RO7049665 on time to relapse following forced CCS tapering as measured by the hazard ratio between 3.5 mg RO7049665 and placebo
    •To evaluate the safety and tolerability of RO7049665 in participants with AIH
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    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 – SUBSTUDY TO ASSESS PHARMACODYNAMIC CHANGES IN
    TISSUE
    Date: 4 Feb 2021
    Version: 1

    Objectives:
    To gain scientific insight
    •into the immunological mechanisms underlying the dynamics in
    Autoimmune hepatitis (AIH),
    •into the mechanism of action (MoA) and pharmacodynamics (PD)
    effects of RO7049665 in liver tissue.
    E.3Principal inclusion criteria
    Age
    •Age between 18 to 75 years

    Type of Participants and Disease Characteristics
    •Patients with a definite diagnosis of AIH (type 1, 2 and 3) as per simplified or revised original diagnostic criteria
    •Patients who have been in biochemical remission for > 2 years prior to randomization
    •Patients who have been on stable treatment for at least 6 months prior to randomization
    •No signs of liver inflammation on a liver biopsy taken no more than 12 months prior to randomization.
    •Patients with AIH who have previously not attempted to taper CCS to 0 mg/day

    Weight
    •Body mass index within the range of 18-35 kg/m2 (inclusive)

    Sex and Contraception/Barrier Requirements
    •Women of childbearing potential, who: agree to remain abstinent or use at least one acceptable contraceptive methods during the treatment period and for at least 28 days after the final dose of study drug
    E.4Principal exclusion criteria
    Medical Conditions
    •Patients 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 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
    •Female patients: Pregnant or lactating
    •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 patient unsuitable for the study, place the patient at undue risk, or interfere with the ability of the patient to complete the study in the opinion of the Investigator
    Prior/Concomitant Therapy
    •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
    •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
    Prior/Concurrent Clinical Study Experience
    •Leukocyte apheresis within 12 weeks of screening.
    •Donation of blood or blood products in excess of 500 mL within 3 months prior to screening.
    •Exposure to any investigational treatment within 6 months prior to Day 1

    Laboratory Abnormalities
    •Abnormal hematologic, hepatic enzyme or hepatic function, biochemistry values

    Other Exclusions
    •History of regular alcohol consumption within 2 months of screening
    •Any suspicion or history of illicit drug use
    •Patients under judicial supervision, guardianship, or curatorship
    E.5 End points
    E.5.1Primary end point(s)
    Time to relapse from randomization
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be assessed when the required number of events has occurred (Approximately 60 months)
    E.5.2Secondary end point(s)
    Efficacy
    1.ALT, AST, and IgG (for both Δ, absolute and relative [upper limit of normal]) over time
    2.Time to relapse from randomization
    3.Incidence and severity of adverse events
    4.Changes in vital signs, physical examination, ECG parameters, and safety laboratory parameters
    5.Anti-drug antibody emergence and neutralizing potential
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-5. The secondary endpoints will be assessed when the required number of events has occurred (Approximately 60 months)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Korea, Republic of
    New Zealand
    Germany
    Italy
    Netherlands
    Portugal
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 84
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Return to standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-11-18
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