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    Summary
    EudraCT Number:2021-001280-24
    Sponsor's Protocol Code Number:VE202-002
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-18
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2021-001280-24
    A.3Full title of the trial
    Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of VE202 in Patients with Ulcerative Colitis
    A.4.1Sponsor's protocol code numberVE202-002
    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 SponsorVedanta Biosciences, Inc.
    B.1.3.4CountryUnited States
    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 supportVedanta Biosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVedanta Biosciences, Inc.
    B.5.2Functional name of contact pointVE202 Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address19 Blackstone St
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18577061427
    B.5.6E-mailconsortium02-ctinquiries@vedantabio.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 nameVE202
    D.3.2Product code VE202
    D.3.4Pharmaceutical form Capsule
    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 INNNot applicable
    D.3.9.2Current sponsor codeVE202-01,3,4,6,7,9,13,14,15,16,18,21,26-29
    D.3.9.3Other descriptive nameJNJ-72537634
    D.3.9.4EV Substance CodeSUB197040
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/g colony forming unit(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200000000
    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 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild-to-moderate ulcerative colitis (UC)
    E.1.1.1Medical condition in easily understood language
    Long-term condition where the colon and rectum become inflamed
    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 8 weeks of treatment with VE202 in terms of endoscopic response at Day 56
    E.2.2Secondary objectives of the trial
    • Evaluate the safety of VE202
    • Evaluate the efficacy of 2 weeks of treatment with VE202 in terms of endoscopic response at Day 56
    • Evaluate the efficacy of 2- and 8-week courses of VE202 in terms of response as measured by Mayo score at Day 56, compared with baseline
    • Evaluate the efficacy of 2- and 8-week courses of VE202 in terms of histologic improvement
    • Evaluate the efficacy of 2- and 8-week courses of VE202 in terms of effect on fecal calprotectin levels
    • Evaluate the impact of 2- and 8-week courses of VE202 on inflammatory bowel disease (IBD)-specific healthcare resource utilization
    • Evaluate the impact of 2- and 8-week courses of VE202 on IBD-specific health-related quality of life
    • Evaluate pharmacokinetics of 2- and 8-week courses of VE202
    • Evaluate pharmacodynamics of 2- and 8-week courses of VE202
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able and willing to provide written informed consent prior to initiation of any study-specific procedure or drug administration and understands the potential risks and benefits of study enrollment and study drug administration. When appropriate, informed consent may be provided by a legally authorized representative (LAR).
    2. Male or female patient who is 18 to 75 years of age.
    3. Documented clinical and endoscopic diagnosis of UC at least 3 months prior to enrollment.
    4. Active mild to moderate UC, as defined by the following:
    ‒ Disease that extends at least 15 cm from the anal verge
    ‒ A modified Mayo score of 4 to 8
    ‒ Mayo endoscopic subscore as follows, based on screening flexible sigmoidoscopy:
    i. Subscore of 1, combined with a fecal calprotectin level of ≥ 150 μg/g, or
    ii. Subscore of 2
    ‒ Rectal bleeding score of ≥ 1
    5. Is up to date with current local colorectal cancer surveillance recommendations (eg, has had a surveillance colonoscopy within 12 months if indicated based on extent and duration of UC); this may be performed during screening.
    6. Has not received a biologic agent or Janus kinase inhibitor for the treatment of UC or any other medical condition.
    7. If receiving corticosteroids, dose must be stable for at least 4 weeks and be no higher than 10 mg QD prednisone (or prednisone equivalent) or budesonide 9 mg QD.
    8. Doses of other allowable UC medications (see Section 8.2.2 for details) must be stable for at least 8 weeks.
    9. If a female patient:
    ‒ Is not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to hysterectomy, bilateral oophorectomy, or bilateral tubal ligation
    ‒ If of childbearing potential, must have a negative pregnancy test and agree to either remain celibate or use a highly effective form of birth control (as defined in Appendix 1) from the time of enrollment until 3 months after the last dose of study drug
    ‒ Agrees not to donate eggs (ova, oocytes) for purposes of assisted reproduction from the time of enrollment until 3 months after the last dose of study drug
    ‒ Is not breastfeeding
    10. If a male patient:
    ‒ If not vasectomized, agrees to wear a condom when engaging in sexual intercourse with any partner of childbearing potential from the time of enrollment until 3 months after the last dose of study drug
    ‒ Agrees not to donate sperm for purpose of reproduction from the time of enrollment until 3 months after the last dose of study drug
    11. Able and willing to follow study procedures (eg, comply with study visits and procedures, provide blood and stool samples).
    E.4Principal exclusion criteria
    1. Known history of CD or indeterminate colitis
    2. A known diagnosis of primary sclerosing cholangitis
    3. Allergy to vancomycin
    4. A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to enrollment
    5. Known or suspected toxic megacolon, abdominal abscess, and/or small bowel ileus at the time of enrollment
    6. Any other anatomic or medical contraindication to flexible sigmoidoscopy
    7. Evidence of an active infection
    8. Recent fever, defined as > 38.0 °C (rectal equivalent) within 3 days prior to randomization
    9. Receipt of FMT or other fecal-derived preparation within 6 months prior to enrollment
    10. Use of systemic or non-absorbable oral antibiotics within the prior 4 weeks or anticipated within the study period
    11. Use of probiotics within the prior 2 weeks (consumption of yogurt and kefir are permissible)
    12. Receipt of herbal, botanical, or traditional medicinal preparations within the prior 2 weeks (consumption of mint, turmeric, or other herbal teas is permissible)
    13. Active drug or alcohol abuse
    14. Active colonic dysplasia
    15. Presence of adenomatous polyp on screening endoscopy, or history of adenomatous polyps that were not removed
    16. Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
    17. Active malignancy within the past 2 years, with the exception of non-melanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has been treated with local excision for curative intent
    18. For female patients, expectation of pregnancy or lactation during the study period
    19. Receipt of any investigational drug or vaccine within the 30 days prior to enrollment
    20. Receipt of any investigational biologic within 60 days or 5 half-lives prior to enrollment, whichever is longer
    21. Aspartate aminotransferase or alanine aminotransferase levels > 3 × ULN
    22. Total or direct bilirubin > 1.5 × ULN
    23. Evidence of decompensated cirrhosis
    24. Serum albumin < 3.0 g/dL
    25. Known active hepatitis B or hepatitis C, or any positive laboratory result consistent with active disease (eg, hepatitis B surface antigen, hepatitis C antibody [unless patient has a history of treatment with successful resolution and an undetectable viral load])
    26. Known human immunodeficiency virus infection or other serious congenital or acquired immunodeficiency
    27. Absolute neutrophil count < 1000/μL
    28. Serum creatinine > 2 × ULN or calculated creatine clearance < 30 mL/min
    29. Inability or unwillingness to comply with protocol requirements
    30. Any other active or poorly controlled comorbid condition that, in the opinion of the Investigator, may be expected to interfere with either study compliance or interpretation of study results
    E.5 End points
    E.5.1Primary end point(s)
    Endoscopic response rate defined as a reduction of 1 point or more in Mayo endoscopic subscore on flexible sigmoidoscopy
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 56
    E.5.2Secondary end point(s)
    • Treatment-emergent adverse events (TEAEs)
    • TEAEs that are related to study treatment
    • Serious adverse events (SAEs)
    • SAEs that are related to treatment
    • Infections
    • Mayo endoscopic subscore on flexible sigmoidoscopy at baseline and Day 56
    • Clinical response
    • Clinical remission
    • Mean change in modified Mayo score
    • Proportion of patients with decrease of at least 1 point and at least 2 points in total Mayo score
    • Endoscopic remission
    • Change in each component of the total Mayo score
    • Histologic change in colonic biopsy as measured by Geboes score and Robarts Histopathology Index (RHI)
    • Histologic response (Geboes score < 3.1; RHI reduction of ≥ 7 points or ≥ 50%)
    • Histologic remission (Geboes score < 2.0; RHI score ≤ 6)
    • Change in fecal calprotectin level
    • Detection of VE202 strains in feces at various time points
    • Abundance of VE202 strains in feces at various time points
    • Duration of VE202 strains in feces
    • Changes in fecal microbiota diversity and taxonomic composition
    • Changes in fecal metabolomic profile (eg, bile acids, SCFA)
    • Hospitalization or surgical procedure related to UC
    • Change in patient-reported outcome measures using the Inflammatory Bowel Disease Questionnaire (IBDQ) and EuroQoL-5D Health Assessment (EQ-5D)
    • Stool Candida burden
    • Immune cell markers on biopsy tissue
    • Inflammatory signals in biopsy tissue
    • Immune cell markers in blood
    • Soluble immune markers in blood
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to schedule of assessment
    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 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Russian Federation
    Ukraine
    United States
    Hungary
    Lithuania
    Netherlands
    Poland
    Czechia
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    When appropriate, informed consent may be provided by a legally authorized representative (LAR) where acceptable according to local country legislation.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 100
    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 will continue to receive standard treatment for their UC after they leave the study at Week 52. As this is the first experience with VE202 in patients with UC, we have not yet formulated a plan for provision of VE202 outside of the current study protocol.
    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 Decision2021-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-17
    P. End of Trial
    P.End of Trial StatusOngoing
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