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    Summary
    EudraCT Number:2019-002485-12
    Sponsor's Protocol Code Number:RP1706
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-09-22
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-002485-12
    A.3Full title of the trial
    VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Determination of the Optimal Treatment Target in Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    VERDICT
    A.4.1Sponsor's protocol code numberRP1706
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04259138
    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 SponsorAlimentiv
    B.1.3.4CountryNetherlands
    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 supportTakeda Development Center Americas, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlimentiv
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address100 Dundas St., Suite 200
    B.5.3.2Town/ cityLondon, ON
    B.5.3.3Post codeN6A 5B6
    B.5.3.4CountryCanada
    B.5.6E-mailregulatory@alimentiv.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 Yes
    D.2.1.1.1Trade name Entyvio
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    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 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 INNvedolizumab
    D.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor codeMLN0002
    D.3.9.3Other descriptive nameVEDOLIZUMAB
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Entyvio
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    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 INNvedolizumab
    D.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor codeMLN0002
    D.3.9.3Other descriptive nameVEDOLIZUMAB
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number108
    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
    Ulcerative Colitis (UC)
    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
    The primary objective of this trial is to determine whether, in subjects with moderately to severely active UC, treating to achieve a target of corticosteroid-free symptomatic + endoscopic + histological remission is superior to a treatment target of corticosteroid-free symptomatic remission, with regards to a primary endpoint of time to UC-related complication within up to 80 weeks of follow-up after achieving target.
    E.2.2Secondary objectives of the trial
    -Evaluate time to UC-related complication: - per (sub)group; - per (sub)group which reaches target and not higher by Week 48
    -Evaluate if treatment to target of: - symptomatic + endoscopic remission (Group 2) is superior to symptomatic remission (Group 1); - corticosteroid-free symptomatic + endoscopic + histological remission (Group 3) is superior to corticosteroid-free symptomatic + endoscopic remission (Group 2)
    -Assess time to achieve respective target per randomized group
    -Assess effect of treatment allocation on UC-related complication
    -Evaluate change in: - fecal calprotectin/CRP/HRQoL/WPAI-UC from baseline to all follow-up visits per (sub)group; - UC-100/Mayo Clinic/ Geboes/RHI/NHI scores from baseline to Weeks 16/32/48/96 per (sub)group
    -Evaluate numbers of AEs and SAEs per (sub)group
    -Explore urine, stool, colonic mucosa, and serum samples for biomarkers and drug concentrations that are associated with clinically important outcomes
    -Validate SIQ-UC tool
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet each of the following criteria for enrollment into the study:
    1. Age ≥ 18 years
    2. Diagnosis of UC confirmed by clinical, endoscopic, and histological evidence prior to screening as per standard criteria
    3. Moderately to severely active UC with a Mayo rectal bleeding subscore ≥ 1 and a MES ≥ 2, with minimum disease extent of 15 cm and objective evidence of inflammation that can be visualized using central endoscopic imaging system
    4. Ability of subject to participate fully in all aspects of this clinical trial
    5. Written informed consent must be obtained and documented
    6. Agree not to participate in an investigational trial for the duration of the trial (observation or other noninterventional trials may be permitted at the discretion of the investigator)
    7. Negative standard of care tuberculosis (TB) test and hepatitis B and C test prior to randomization, unless negative results available from within 12 months prior
    8. A male subject who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception* from signing of informed consent throughout the duration of the study and for 18 weeks after last dose
    9. A female subject of childbearing potential* who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose
    10. Up to date with colorectal carcinoma surveillance according to local standards and guidelines. If a subject is not up to date at screening, a standard of care surveillance assessment may be performed during the screening period.
    11. Subjects who are not responding to their existing treatment for UC (Netherlands-specific criterion).
    E.4Principal exclusion criteria
    Subjects who exhibit any of the following conditions are ineligible for the study:
    1. Subjects who have historically failed (i.e., had an inadequate response with, lost response to, or were intolerant to) 2 or more compounds or classes of advanced therapeutic options (biologics or small molecules; e.g., anti-TNFs, ustekinumab, or tofacitinib) for the treatment of their UC
    2. Current or previous treatment with vedolizumab, etrolizumab, or natalizumab
    3. Topical therapy (corticosteroid or 5-aminosalicylate [5-ASA]) use within 2 weeks prior to screening endoscopy
    4. Change to oral corticosteroid dosing within 2 weeks prior to randomization or a corticosteroid dose of > 30 mg of prednisone or equivalent at randomization
    5. Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis
    6. Short gut syndrome
    7. Positive stool culture for or active Clostridiodes difficile infection
    8. Known hepatitis B or C infection; if a negative test result is available in the 12 months prior to randomization, retesting is not required.
    9. Known active or latent TB; if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before randomization.
    10. Received any investigational drug within 30 days prior to randomization/target assignment.
    11. Serious underlying disease other than UC that in the opinion of the investigator may interfere with the subject’s ability to participate fully in the study or would compromise subject safety (such as history of malignancies, major neurological disorders, any unstable or uncontrolled medical disorder).
    12. History of alcohol or drug abuse that in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
    13. The subject has active cerebral/meningeal disease, signs/symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization.
    14. Hypersensitivity to any excipient of vedolizumab.
    15. Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.
    16. History of HIV or positive test at screening (Italy-specific criterion).
    17. Any other contraindication(s)to vedolizumab (Italy-specific criterion).
    18. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after the last dose; or intending to donate ova during such time period.
    19. If male, the subject intends to donate sperm during the course of this study or for 18 weeks after the last dose.
    20. Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination during conduct of the study, except vaccination for coronavirus disease of 2019 (COVID-19).
    E.5 End points
    E.5.1Primary end point(s)
    Time to UC-related complication.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 80 weeks of follow-up after achieving target of corticosteroid-free symptomatic + endoscopic + histological remission.
    E.5.2Secondary end point(s)
    1. Time to UC-related complications in the full analysis set, including subgroups on and off corticosteroids at the time of achieving other relevant components of the treatment target
    2. Whether treatment to the target of symptomatic + endoscopic remission (Group 2) is superior to a treatment target of symptomatic remission (Group 1) in terms of the primary endpoint (both in the full and the achieved target populations)
    3. Whether treatment to the target of corticosteroid-free symptomatic + endoscopic + histologic remission (Group 3) is superior to a treatment target of corticosteroid-free symptomatic + endoscopic remission (Group 2) in terms of the primary endpoint (both in the full and the achieved-target populations)
    4. Time to UC-related complication (as in the primary outcome and secondary outcomes 2 and 3) in the subgroup of subjects who exclusively reach their assigned target and not a higher target by Week 48
    5. Time taken to achieve the respective targets among the 3 randomized groups. Time will be censored for subjects who do not achieve their assigned target by Week 48
    6. Across the 3 randomized groups, time to each type of UC-related complication separately that comprises the primary endpoint (both in the full and achieved-target populations)
    7. The effect of treatment allocation on UC-related complication that is mediated through treatment targets
    8. Change in fecal calprotectin levels from baseline to Weeks 8, 16, 32, 48, and 96 (both in the full and the achieved-target populations)
    9. Change in C-reactive protein (CRP) concentration from baseline to Weeks 8, 16, 32, 48, 64, 80, and 96 (both in the full and the achieved-target populations)
    10. Change in the UC-100 score from baseline to Weeks 16, 32, 48, and 96 (both in the full and the achieved target populations)
    11. Change in health-related quality of life (HRQoL) using the Inflammatory Bowel Disease Questionnaire (IBDQ) from baseline to Weeks 16, 32, 48, 64, 80, and 96 (both in the full and the achieved-target populations)
    12. Change in the Work Productivity and Activity Impairment-UC (WPAI-UC) questionnaire from baseline to Weeks 16, 32, 48, 64, 80, and 96 (both in the full and the achieved-target populations)
    13. Change in Mayo Clinic Score (MCS; and subcomponents including the MES) from baseline to Weeks 16, 32, 48, and 96 (both in the full and the achieved-target populations)
    14. Change in Geboes score from baseline to Weeks 16, 32, 48, and 96 (both in the full and the achieved-target populations)
    15. Change in Robarts Histological Index (RHI) scores from baseline to Weeks 16, 32, 48, and 96 (both in the full and the achieved-target populations)
    16. Change in Nancy Histological Index scores from baseline to Weeks 16, 32, 48, and 96 (both in the full and the achieved-target populations)
    17. The numbers of AEs and SAEs among the 3 randomized groups
    18. Evaluation of urine, stool, colonic mucosa, and serum samples for biomarkers and drug concentrations that are associated with clinically important outcomes
    19. Validation of the SIQ-UC tool in English-fluent subjects, as described in the SAP
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and Weeks 8/16/32/48/64/80/96 (as specified in E.5.2 Secondary end point(s))
    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 No
    E.6.7Pharmacodynamic No
    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
    Comparison of treatment algorithms to reach treatment target.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Study subjects will be blinded to group allocation, whereas investigators will be unblinded.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Participants are randomized to treatment target.
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Ukraine
    Belarus
    Canada
    Russian Federation
    United Kingdom
    United States
    Belgium
    France
    Italy
    Netherlands
    Poland
    E.8.7Trial has a data monitoring committee No
    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
    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 months3
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 561
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 99
    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 state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 660
    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)
    After a subject has ended their participation in the trial, they will return to standard of care and may remain on vedolizumab at the discretion of their investigator.
    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 Decision2021-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-29
    P. End of Trial
    P.End of Trial StatusOngoing
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