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    EudraCT Number:2020-004355-33
    Sponsor's Protocol Code Number:MH002-UC-201
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-07-01
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2020-004355-33
    A.3Full title of the trial
    Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Mechanistic Effects, and Effects on Disease Activity of MH002 in Subjects with Mild to Moderate Ulcerative Colitis: A First-in-human Study
    Randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení
    posuzující bezpečnost přípravku MH002 a jeho mechanismus účinku a účinky na aktivitu onemocnění u pacientů s mírnou až středně závažnou ulcerózní kolitidou: první studie s lidskými účastníky
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitis
    První klinické hodnocení s lidskými účastníky zkoumající přípravek MH002 u pacientů s mírnou až stř
    A.4.1Sponsor's protocol code numberMH002-UC-201
    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 SponsorMRM Health NV
    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 supportMRM Health NV
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMRM Health NV
    B.5.2Functional name of contact pointMH002-FIH Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressTechnologiepark-Zwijnaarde 73 (iso 94)
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9052
    B.5.4Telephone number+3292411188
    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 nameMH002
    D.3.2Product code MH002
    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.3.9.1CAS number No
    D.3.9.2Current sponsor codeMH002
    D.3.9.3Other descriptive nameMH002
    D.3.9.4EV Substance CodeSUB241149
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typeLive Biotherapeutic Product.
    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
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10009900
    E.1.2Term Colitis ulcerative
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 safety and tolerability of MH002 in subjects with mild to moderate ulcerative colitis (UC)
    E.2.2Secondary objectives of the trial
    • To evaluate the effect on disease activity of MH002 in UC
    • To evaluate the mechanistic effects of MH002 in UC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged ≥18 years and ≤75 years,
    2. Documented diagnosis (histologic diagnosis and either endoscopic or radiographic diagnosis) of UC at least 3 months prior to Screening (a biopsy report supporting the histologic diagnosis must be available),
    3. Confirmed diagnosis of mild to moderate UC at Screening as defined by an MMS ≥4 but <8 and MES of 2 or 3(central reading).
    4. Left-sided colitis lesions ≥10 cm,
    5. Subject should be receiving a stable dosing (topical or systemic) regimen of 5-ASA (eg, Asacol, Pentasa, Lialda, Apriso, Delzicol) ≥4 weeks prior to randomization and continue on that same regimen during the study,
    6. Females of childbearing potential (FOCBP) must agree to utilize an acceptable effective or highly effective contraceptive method of birth control, eg, use a male or female condom with or without spermicide or any prescription hormonal contraceptive, during study participation at a minimum and
    7. Subject should provide written informed consent
    E.4Principal exclusion criteria
    1. Diagnosis of Crohn’s Disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon,
    2. Evidence of a clinically significant, active infection of the gastrointestinal tract (eg, Salmonella, Shigella, Yersinia, Campylobacter, Escherichia coli, Giardia lamblia, Vibrio, Aeromonas, Plesiomonas, Cryptosporidium, and toxigenic Clostridium difficile) or of any other organ system at Screening, unless deemed benign (eg, mild common cold),
    3. Ulcerative proctitis involving only the rectum,
    4. Severe UC as per modified Truelove Witts’ criteria or patients in whom colitis is most severe in the transverse colon or ascending colon,
    5. Total colectomy, stoma or ileo-anal pouch, or history of extensive colonic resection leaving less than 30 cm of colon,
    6. Presence of intra-abdominal fistula, abscesses, diverticulitis, or gastrointestinal bleeding unrelated to UC,
    7. History of colon carcinoma or high-grade dysplasia or absence of total endoscopy ≤18 months in a subject suffering from UC ≥8 years,
    8. Previous use of any anti-TNF (eg, Infliximab), anti-integrin antibodies (eg, Entyvio) or Janus kinase inhibitors (eg, tofacitinib),
    9. Use of sulfasalazine ≤4 weeks prior to randomization into the study,
    10. Use of corticosteroids or any disease-modifying antirheumatic drug (DMARD), including thiopurines (eg, Imuran) ≤6 weeks prior to randomization into the study, except for a stable, low dose of oral corticosteroids (≤8 mg methylprednisolone/day or equivalent) for at least 2 weeks prior to colonoscopy and remaining on the same dose up to Visit 8/EDV,
    11. Conditions linked to severe immunosuppression (eg, human immunodeficiency virus, malignancies, liver cirrhosis, systemic chemotherapy),
    12. Leukopenia (total white blood cell count <3500/μL) and/or neutropenia (absolute neutrophil count <1500/μL),
    13. Severe anemia (hemoglobin <10 g/dL),
    14. Thrombocytopenia (peripheral blood platelet count <100 × 109/L), or any coagulation disorder with significantly increased risk of bleeding,
    15. Ongoing or recent (<3 months), significant renal disease or insufficiency as manifested, eg, by medical history and/or clinical examination and/or (calculated or measured) glomerular filtration rate significantly outside normal limits for age and sex,
    16. Ongoing or recent (<3 months), significant hepatic disease as manifested by medical history and/or clinical examination and/or an increase in 2.5 × the upper limit of normal for alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transpeptidase, or alkaline phosphatase,
    17. Clinically significant bone marrow disease if progressive or not controlled,
    18. Any protein-losing enteropathy (any cause),
    19. Any systemic (autoimmune) disease if progressive or not controlled (uncomplicated and well-controlled diabetes mellitus is allowed),
    20. Any granulomatous disease,
    21. Increased risk of developing infectious endocarditis including:
    - Prosthetic cardiac valves including transcatheter-implanted prostheses and homografts,
    - Prosthetic material used for cardiac valve repair such as annuloplasty rings and chords,
    - Previous infectious endocarditis, and
    - Unrepaired cyanotic congenital heart disease or repaired congenital heart disease, with residual shunts or valvular regurgitation at the site of or adjacent to the site of a prosthetic patch or prosthetic device
    22. Any history of solid organ or bone marrow transplantation,
    23. Use of antibiotics (except for local use), prebiotics, or probiotics ≤4 weeks prior to randomization or anticipated during participation, concomitant, chronic use of an antidiarrheal drug, or concomitant use of any rectal treatment (5-ASA excepted),
    24. History of intravenous drug abuse,
    25. Alcohol abuse disorder as assessed by the Investigator,
    26. Pregnancy or lactation,
    27. Treatment with another investigational drug or intervention within 30 days prior to Screening, and
    28. Subjects who to the Investigator’s discretion are inappropriate for the study, including:
    - Subjects with any other condition, disorder, or disease that in the Investigator’s judgment would make the subject unsuitable for inclusion in the study (eg, recent major surgery, severe disorder or disease, state of malnutrition, or contraindication for colonoscopy with biopsy),
    - Subjects who in the opinion of the Investigator are not likely to complete the study for whatever reason (eg, short life expectancy), and
    - Subjects who are unwilling or unable to comply with protocol requirements, eg, complete the full course of study treatment per schedule, attend study visits and all required assessments/investigations, and complete an electronic diary (eg, planned surgery or moving abroad)
    - An employee of the Principal Investigator, clinical center, contract research organization or Sponsor. A relative of an employee of the clinical center, the investigators, contract research organization, or the Sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of treatment-emergent adverse events.(TEAEs).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 2, week 4, week 8, week 10, week 12, week 16 and Phone calls: Day 3, Day7(8) and week 19
    E.5.2Secondary end point(s)
    To evaluate the effects on disease activity of MH002 in UC
    • 3-item Modified Mayo Score (MMS): sum of the Mayo symptom subscores for stool frequency and rectal bleeding and centrally assessed Mayo Endoscopic Score (MES), ie, without the Physician’s Global Assessment of disease activity,
    • MMS subscores, ie, stool frequency, rectal bleeding, and MES,
    • Rate of ‘clinical response’, defined as a decrease of ≥3 points on the MMS and/or a decrease of ≥1 on the stool frequency subscore + a decrease of ≥1 on the rectal bleeding subscore,
    • Rate of ‘clinical remission’, defined as MMS ≤2 and with all MMS subscores ≤1 and a rectal bleeding subscore of 0,
    • Histologic scores (Nancy Index, Geboes Score, and Robarts Histopathology Index) of colonic biopsies, and
    To evaluate the mechanistic effects of MH002 in UC:
    • Changes in stool consistency based on Bristol Stool Form Scale.
    • The differential expression of genes in the context of barrier integrity, including tight junction, mucin, cell proliferation, and differentiation genes (transcriptomics based on RNA-sequencing of colonic biopsies).
    • The differential expression of genes in the context of modulation of inflammation and immunity (transcriptomics based on RNA-sequencing of colonic biopsies).
    • Extent of inflammation by evaluating biomarkers in blood (including C-reactive protein, tumor necrosis factor α, and interleukins) and in feces (fecal calprotectin).
    • Changes in the composition of the fecal microbiome (metagenomics based on deep sequencing of fecal samples).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 8 and week 16
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 45
    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)
    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 Decision2021-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-05-23
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