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    Summary
    EudraCT Number:2013-004278-88
    Sponsor's Protocol Code Number:GA28950
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-06
    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 ConcernedGermany - PEI
    A.2EudraCT number2013-004278-88
    A.3Full title of the trial
    PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,
    MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF
    ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN
    PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE
    COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF
    INHIBITORS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.
    A.3.2Name or abbreviated title of the trial where available
    HICKORY
    A.4.1Sponsor's protocol code numberGA28950
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02100696
    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. Hoffmann-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 nameetrolizumab
    D.3.2Product code Ro 549-0261/F04
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNETROLIZUMAB
    D.3.9.1CAS number 1044758-60-2
    D.3.9.2Current sponsor codeRO5490261
    D.3.9.3Other descriptive namerhuMAb Beta7, Anti Beta7, PRO145223
    D.3.9.4EV Substance CodeSUB75320
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number105
    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 Yes
    D.3.11.13.1Other medicinal product typerecombinant humanized IgG1 monoclonal antibody
    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 in pre-filled syringe
    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
    Ulcerative colitis (UC)
    E.1.1.1Medical condition in easily understood language
    A form of inflammatory bowel disease.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of etrolizumab (105 mg subcutaneous [SC] every 4 weeks [Q4W]) compared with placebo for the induction of remission as determined by the Mayo Clinic Score (MCS) at Week (W) 14.
    • To evaluate the efficacy of etrolizumab (105 mg SC Q4W) compared with placebo for remission at W66 among patients with a clinical response at W14, as determined by the MCS
    E.2.2Secondary objectives of the trial
    • Clinical remission at W14 and W66
    • Clinical response at W14
    • Improvement in endoscopic appearance of the mucosa at W14 and W66
    • Endoscopic and histologic remission at W14 and W66
    • Change from baseline (BL) in rectal bleed and stool frequency subscore at W6
    • Change from BL in UC bowel movement signs and symptoms and abdominal symptoms at W14 and W66, as assessed by Ulcerative Colitis Patient Reported Outcome Signs and Symptoms (UC-PRO/SS)
    • Change from BL in Patient Reported health related Quality of Life at W14 and W66, as assessed by Inflammatory Bowel Disease Questionnaire (IBDQ)
    • Clinical remission at W66 in patients in clinical remission at W14
    • Remission at W66 among patients in remission at W14
    • Corticosteroid (CS)-free clinical remission and remission at W66 in patients receiving CSs at BL
    • Etrolizumab Serum Concentration
    • Percentage of participants with Adverse Events
    • Percentage of participants with Anti-Therapeutic Antibodies to Etrolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
    - 18-80 years of age, inclusive
    - Diagnosis of UC established at least 3 months prior to Day 1
    - Moderately to severely active UC as determined by the MCS
    - Washout of TNF inhibitor therapy for at least 8 weeks preceding Day 1
    - Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
    - Use of highly effective contraception as defined by the protocol
    - Have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening
    E.4Principal exclusion criteria
    - A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps.
    - Prior or planned surgery for UC.
    - Past or present ileostomy or colostomy.
    - Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol.
    - Any prior treatment with anti-adhesion molecules (e.g., anti-MAdCAM-1)
    - Any treatment with tofacitinib during screening
    - Congenital or acquired immune deficiency, chronic hepatitis B or C infection, Human Immunodeficiency Virus (HIV) positive, or history of tuberculosis (active or latent)
    - Evidence of or treatment for Clostridium difficile within 60 days prior to Day 1 or other intestinal pathogens within 30 days prior to Day 1
    - History of recurrent opportunistic infections, severe disseminated viral infections and organ transplant
    - Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to Screening
    - Received a live attenuated vaccine within 4 weeks prior to Day 1
    E.5 End points
    E.5.1Primary end point(s)
    1) Remission at W 14 as determined by the Mayo Clinic Score (MCS).
    2) Remission at W 66 among patients with a clinical response at W 14 as determined by MCS
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) at week 14
    2) at week 66
    E.5.2Secondary end point(s)
    Percentage of participants in/with
    1. Clinical remission at W14 and W66, as determined by MCS
    2. Clinical response at W14, as determined by MCS
    3. Improvement in endoscopic appearance of the mucosa at W14 and W66, as determined by Mayo Endoscopic Subscore
    4. Endoscopic and histologic remission at W14 and W66, as determined by Mayo Endoscopic Subscore and Nancy Histological Index (NHI) respectively
    5. Change from baseline in rectal bleed and stool frequency subscore at W6, as determined by Mayo rectal bleeding and stool frequency Subscores respectively
    6. Change from baseline in UC bowel movement signs and symptoms and abdominal symptoms at W14 and W66, as assessed by UC-PRO/SS
    7. Change from baseline in health-related Quality of Life at W14 and W66, as assessed by IBDQ
    8. Clinical remission at W66 among patients in clinical remission at W14, as determined by MCS
    9. Remission at W66 among patients in remission at W14, as determined by MCS
    10. Corticosteroid (CS)- free clinical remission and remission at W66 in patients who were receiving CSs at baseline, as determined by MCS
    11. Etrolizumab Serum Concentration
    12. Adverse Events
    13. Anti-Therapeutic Antibodies to Etrolizumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. W14, W66
    2. W14
    3-4. W14, W66
    5. Baseline (Day-35- Day-1), W6 6-7. Baseline, W14, W66
    8-9. W14 and W66
    10. W66
    11. Pre-dose (0 hour) on Day 1, Post-dose W14, W24, W44, W66, early termination/end of safety follow-up (up to W78)
    12. Baseline up to end of study (up to W78)
    13. Pre-dose (0 hour) on Day 1, Post-dose W4, W14, W24, W44, W66, early termination/end of safety follow-up (up to W78)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Assessment of dynamic biomarker; retention of samples for genetic analysis; health-related quality of life (QOL)
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Cohort 1 (open label) and Cohort 2 (blinded)
    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 trial5
    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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA151
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Korea, Republic of
    Lithuania
    Mexico
    Netherlands
    Poland
    Romania
    Spain
    Switzerland
    United Kingdom
    United States
    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
    The end of the study is defined as the last patient last safety follow up visit in this protocol or last patient in this protocol transferred to the OLE SM study (Study GA28951), whichever is later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 575
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 366
    F.4.2.2In the whole clinical trial 605
    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)
    Patients who don't achieve a clinical response at Week 14, patients who have clin relapse during the Maintenance Phase, patients who receive defined rescue treatment, patients who complete 66 weeks of the study will continue to receive open label etrolizumab treatment in the OLE-SM study GA28951.
    All other patients will enter a 12 week safety FU after the last dose of study treatment and will then be transferred to the GA28951 only for an extended period of FU for PML.
    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 Decision2014-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-16
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