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    Summary
    EudraCT Number:2019-004652-11
    Sponsor's Protocol Code Number:MA41419
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-31
    Trial 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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2019-004652-11
    A.3Full title of the trial
    RANDOMIZED, OPEN-LABEL PHASE 3B STUDY OF ETROLIZUMAB BASED INDUCTION THERAPY COMBINATIONS FOLLOWED BY ETROLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS
    Randomizirana, odprta raziskava faze 3b o kombiniranih indukcijskih zdravljenjih na podlagi etrolizumaba, ki jim sledi vzdrževalno zdravljenje z etrolizumabom, pri bolnikih z zmernim do hudim ulceroznim kolitisom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    Lantana
    A.4.1Sponsor's protocol code numberMA41419
    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 RO5490261/F04-02
    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 No
    D.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics B.V., The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeRO6897845
    D.3.9.3Other descriptive nameINFLIXIMAB
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Xeljanz
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe, Belgium
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOFACITINIB
    D.3.9.1CAS number 477600-75-2
    D.3.9.2Current sponsor codeRo 516-9503
    D.3.9.3Other descriptive nameTOFACITINIB
    D.3.9.4EV Substance CodeSUB33104
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 4
    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 Yes
    D.2.1.1.1Trade name Xeljanz
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe, Belgium
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOFACITINIB
    D.3.9.1CAS number 477600-75-2
    D.3.9.2Current sponsor codeRo 516-9503
    D.3.9.3Other descriptive nameTOFACITINIB
    D.3.9.4EV Substance CodeSUB33104
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 5
    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 Yes
    D.2.1.1.1Trade name Stelara
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV, Belgium
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeRo 723-3920
    D.3.9.3Other descriptive nameUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    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.IMP: 6
    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 Yes
    D.2.1.1.1Trade name Stelara
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV, Belgium
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeRo 723-3920
    D.3.9.3Other descriptive nameUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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
    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
    UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers
    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 induction therapy with etrolizumab-based combinations compared to etrolizumab monotherapy, assessed as corticosteroid-free endoscopic improvement at Week 14
    E.2.2Secondary objectives of the trial
    • Induction of corticosteroid-free: remission, clinical response, endoscopic remission, histologic remission, symptomatic remission, rectal bleeding score 0, remission at Week 14 in patients receiving corticosteroids at baseline
    • Change in UC- Patient-Reported outcome (PRO) signs/symptoms and UC/PROs related to various aspects of QoL (quality of life) (induction and maintenance phase)
    • Remission at Week 54 among patients with clinical response and remission at Week 14, respectively
    • Endoscopic remission at Week 54 among patients in endoscopic remission and endoscopic improvement at Week 14, respectively
    • Histologic remission at Week 54
    • Corticosteroid-free remission at Week 54 in patients who were in corticosteroid-free remission at Week 14.
    • Overall safety and tolerability of etrolizumab-based combinations compared to etrolizumab monotherapy
    • The incidence and severity of immunosuppression-related adverse events and hypersensitivity reactions
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cohort 1 only
    • Age 18−80 years of age, inclusive, at time of signing Informed Consent Form
    • Naïve to treatment with infliximab and ustekinumab
    • Prior treatment with investigational JAK inhibitors for UC and other investigational treatments for UC (except for investigational anti-integrins) is allowed if discontinued at least 5 drug half-lives prior to randomization
    Cohort 2 only
    • Age 18−49 years of age, inclusive, at time of signing Informed Consent Form
    • Naïve to treatment with tofacitinib
    • Prior treatment with infliximab and ustekinumab is allowed if discontinued at least 5 drug half-lives prior to randomization (Day 1), or when serum drug levels of infliximab/ustekinumab are undetectable as measured using a commercial assay (if available), whichever is earlier
    • Prior treatment with investigational treatments for UC is allowed if discontinued at least 5 drug half-lives prior to randomization (Day 1)
    Cohort 1 and Cohort 2
    • Ability to comply with the study protocol, in the investigator's judgment
    • Diagnosis of UC established at least 3 months prior to randomization (Day 1) by clinical and endoscopic evidence. This diagnosis should be corroborated by histopathology conducted at any time prior to screening and documented by a histopathology report
    • Moderate-to-severely active UC as determined by an mMCS of 4–9, with an endoscopic subscore ≥ 2 as determined by the central reading procedure, a rectal bleeding subscore ≥ 1, and a stool frequency subscore ≥ 1, during the screening period (prior to randomization [Day 1])
    • Evidence of UC extending more than 15 cm from the anal verge as determined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed during screening, 4−16 days prior to randomization
    • Naïve to treatment with etrolizumab or other anti-integrin agents
    • Prior treatment with immunosuppressants (AZA, MTX, or 6-MP) is allowed if discontinued at least 5 drug half-lives (i.e. 5 days) prior to randomization (Day 1)
    • Prior treatment with non-infliximab aTNF-α therapy (e.g., adalimumab, golimumab) is allowed if discontinued at least 4 weeks (for adalimumab) or 6 weeks (for golimumab) prior to randomization (Day 1), or when serum drug levels are undetectable as measured using a commercial assay (if available), whichever is earlier
    • Patients must not have received more than two biological therapies intended to treat UC prior to Day 1
    • Patients must have had an inadequate response, loss of response, or intolerance to prior immunosuppressant and/or corticosteroid treatment
    • Any ongoing UC therapy must be at stable doses:
    • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 6 months after the final dose of study treatment
    • For men who are not surgically sterile: agreement to remain abstinent or use contraception during the treatment period and for at least 6 months after the final dose of study treatment. Men must refrain from donating sperm during this same period.
    • Patients must be up-to-date on their colorectal carcinoma (CRC) surveillance according to local standards and guidelines. If patients are not up-to-date, they must be willing to undergo a colonoscopy with appropriate CRC screening biopsies in lieu of a flexible sigmoidoscopy at screening


    E.4Principal exclusion criteria
    Inflammatory Bowel Disease
    Cohort 1+2:
    • Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
    • Past or present ileostomy or colostomy
    • Diagnosis of indeterminate colitis
    • Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
    • Diagnosis of toxic megacolon within 12 months of initial screening visit
    • Any diagnosis of Crohn’s disease
    • Past or present fistula or abdominal abscess
    • Current evidence of colonic mucosal dysplasia or history of colonic mucosal dysplasia within 5 years prior to inclusion
    • Patients with any stricture (stenosis) of the colon
    • Patients with history or evidence of adenomatous colonic polyps that have not been removed
    Exclusion Criteria Related to Prior or Concomitant Therapy
    Cohort 1 only
    • Any prior treatment with infliximab or ustekinumab
    Cohort 2 only
    • Any prior treatment with tofacitinib
    • Prior treatment with investigational JAK inhibitors for UC
    • Receiving treatment with single or combined hormonal contraception therapy
    • Current treatment with potent inhibitors of CYP3A4 or receiving one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 that would increase serum availability of tofacitinib
    Cohort 1+2
    • Any prior treatment with etrolizumab or other anti-integrin agents
    • Any prior treatment with anti-adhesion molecules
    • Receiving treatment with immunosuppressants (AZA, 6-MP, or MTX) within the 5 drug half-lives(ie. 5 days) prior to Day 1
    • Use of IV steroids within 30 days prior to screening with the exception of a single administration of IV steroid
    • Use of agents that deplete B or T cells within 12 months prior to randomization, with the exception of AZA and 6-MP (which must be discontinued 5 half-lives (i.e. 5 days) prior to Day 1 )
    • Use of cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 4 weeks prior to randomization
    • Chronic nonsteroidal anti-inflammatory drug (NSAID) use
    • Patients who are currently using anticoagulants
    • Patients who have received treatment with corticosteroid enemas/suppositories and/or topical (rectal) 5-ASA preparations within 2 weeks prior to randomization
    • Apheresis within 2 weeks prior to randomization
    • Received any investigational treatment including investigational vaccines within 5 half-lives of the investigational product or 28 days after the last dose (whichever is greater) prior to randomization
    • History of moderate or severe allergic or anaphylactic/anaphylactoid or hypersensitivity reactions to chimeric, human, or humanized antibodies, fusion proteins, or murine proteins
    • Patients administered tube feeding, defined formula diets, or parenteral alimentation/nutrition who have not discontinued these treatments ≥ 3 weeks prior to randomization
    Exclusion Criteria related to General Safety
    Cohort 1 only
    • History of moderate-to-severe heart failure New York Heart Association [NYHA] Class III/IV
    Cohort 2 only
    • History of heart failure
    • Patients with inherited coagulation disorders
    • History of venous thromboembolism, either deep venous thrombosis or pulmonary embolism
    • Patients undergoing major surgery
    Cohort 1+2
    • Lack of peripheral venous access
    • Significant uncontrolled comorbidity
    • Neurological conditions or diseases that may interfere with monitoring for PML
    • History of demyelinating disease
    • Clinically significant abnormalities on screening neurologic examination
    • Clinically significant abnormalities on the screening PML Subjective Checklist
    • History of alcohol, drug, or chemical abuse ≤ 6 months prior to screening
    • Use of marijuana ≤ 3 months prior to screening
    • Conditions other than UC that could require treatment with > 10 mg/day of prednisone during the course of the study
    • A history of primary sclerosing cholangitis
    • Patients with a history of GI perforation
    • History of cancer
    Exclusion Criteria related to Infection Risk
    Cohort 1+2
    • Congenital or acquired immune deficiency
    • Patients must undergo screening for HIV and test positive for preliminary and confirmatory tests
    • Positive hepatitis C virus (HCV) antibody test result
    • Patients must undergo screening for hepatitis B virus (HBV)
    • Evidence of or treatment for Clostridium difficile within 60 days prior to randomization or other intestinal pathogens within 30 days prior to randomization
    • Any diagnosis of cytomegalovirus (CMV) colitis in the past 60 days
    • History of active or latent TB regardless of treatment history
    • History of recurrent opportunistic infections and/or history of severe disseminated viral infections
    • Any serious opportunistic infection within the last 6 months
    • Any current or recent signs or symptoms of infection
    • Any major episode of infection requiring treatment with IV antibiotics
    • Received any live attenuated vaccine within 4 weeks prior to randomization
    • History of organ transplant







    E.5 End points
    E.5.1Primary end point(s)
    1. Corticosteroid-free endoscopic improvement at Week 14
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 14
    E.5.2Secondary end point(s)
    1. To evaluate induction of corticosteroid-free remission at Week 14, as assessed by the mMCS
    2. To evaluate corticosteroid-free clinical response at Week 14, as assessed by the mMCS
    3. To evaluate corticosteroid-free endoscopic remission at Week 14
    4. To evaluate corticosteroid-free histologic remission at Week 14
    5. To evaluate corticosteroid-free symptomatic remission at Week 14
    6. To evaluate onset of action, defined as time to rectal bleeding score of 0
    7. To evaluate onset of action, defined as change from baseline (Day 1) in stool frequency subscore at Week 2, Week 4, and Week 6
    8. To evaluate change in UC bowel movement signs and symptoms from baseline (Day 1) to Week 14, as assessed by the Ulcerative Colitis-Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) measure
    9. To evaluate change in UC functional symptoms from baseline (Day 1) to Week 14, as assessed by the UC-PRO/SS measure
    10. To evaluate change in UC systemic symptoms from baseline (Day 1) to Week 14, as assessed by the UC-PRO Systemic Symptoms measure
    11. To evaluate change in UC daily coping strategies, daily life impact, and emotional impact from baseline (Day 1) to Week 14, as assessed by the UC-PRO Daily Coping (UC-PRO-DC), UC-PRO Daily Life Impact (UC-PRO-DLI), and UC-PRO Emotional Impact (UC-PRO-EI) measures
    12. To evaluate change from baseline (Day 1) in patient-reported health-related quality of life at Week 14, as assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)
    13. To evaluate corticosteroid-free remission at Week 14 (off corticosteroid for at least 4 weeks prior to Week 14) in patients who were receiving corticosteroids at baseline (Day 1), as assesses by mMCS
    14. To evaluate remission at Week 54 among patients with clinical response at Week 14
    15. To evaluate remission at Week 54 among patients in remission at Week 14
    16. To evaluate endoscopic remission at Week 54 among patients in endoscopic remission at Week 14
    17. To evaluate endoscopic remission at Week 54 among patients with endoscopic improvement at Week 14
    18. To evaluate histologic remission at Week 54
    19. To evaluate corticosteroid-free remission at Week 54 in patients who were in corticosteroid-free remission at Week 14
    20. To evaluate corticosteroid-free (at least 24 consecutive weeks during maintenance) remission at Week 54 among patients who were in corticosteroid-free remission at Week 14
    21. To evaluate symptomatic remission at Week 54 among patients with clinical response at Week 14
    22. To evaluate change in UC bowel movement signs and symptoms from baseline (Day 1) to Week 14 and Week 14 to Week 54, as assessed by the UC-PRO/SS measure
    23. To evaluate change in UC functional symptoms from baseline (Day 1) to Week 14 and Week 14 to Week 54, as assessed by the UC-PRO/SS measure
    24. To evaluate change in UC systemic symptoms from baseline (Day 1) to Week 14 and Week 14 to Week 54, as assessed by the UC-PRO Systemic Symptoms measure
    25. To evaluate change in UC daily coping strategies, daily life impact, and emotional impact from baseline (Day 1) to Week 14 and Week 14 to Week 54, as assessed by the UC-PRO Daily Coping (UC-PRO-DC), UC-PRO Daily Life Impact (UC-PRO-DLI), and UC-PRO Emotional Impact (UC-PRO-EI) measures
    26. To evaluate change in patient-reported health related quality of life from baseline (Day 1) to Week 14 and Week 14 to Week 54, as assessed by the IBDQ
    27. To evaluate the overall safety and tolerability of etrolizumab-based combinations compared to etrolizumab monotherapy
    28. To evaluate the incidence and severity of immunosuppression-related adverse events
    29. To evaluate the incidence and severity of hypersensitivity reactions
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-5. Week 14
    6. Up to Week 54
    7. Week 2, Week 4, and Week 6
    8-13. Baseline (Day 1) to Week 14
    14-21. Week 14, Week 54
    22-26. Baseline to Week 14 and Week 14 to Week 54
    27-29. Up to Week 66
    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
    Immunogenicity
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 EEA77
    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
    Austria
    Belgium
    Brazil
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Ireland
    Israel
    Italy
    Latvia
    Netherlands
    Poland
    Russian Federation
    Serbia
    Slovakia
    Slovenia
    Spain
    Switzerland
    Turkey
    Ukraine
    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 this study is defined as the date when the last patient, last safety follow-up visit occurs.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 361
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 184
    F.4.2.2In the whole clinical trial 372
    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)
    The Sponsor will offer continued access to Roche IMP (etrolizumab) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product - see protocol MA41419 v3, section 4.3.5.
    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 Decision2020-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-23
    P. End of Trial
    P.End of Trial StatusOngoing
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