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    Summary
    EudraCT Number:2021-006656-14
    Sponsor's Protocol Code Number:MH002-PC-201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-006656-14
    A.3Full title of the trial
    Exploratory Study to Evaluate Safety, Mechanistic and Clinical Effects of MH002 in Subjects with Acute Pouchitis
    Studio Esplorativo per Valutare Sicurezza ed Effetti Meccanicistici e Clinici di MH002 in Soggetti con Pouchite Acuta
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test safety and look at effects of MH002 in subjects with Acute Pouchitis
    Studio per valutare la sicurezza e vedere gli effetti di MH002 in soggetti con Pouchite Acuta
    A.3.2Name or abbreviated title of the trial where available
    MH002 Exploratory Pouchitis Study
    Studio esplorativo su MH002 nella Pouchite
    A.4.1Sponsor's protocol code numberMH002-PC-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
    B.1.3.4CountryBelgium
    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.4.2CountryBelgium
    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 82
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number003292770850
    B.5.6E-mailMH002-FIH@mrmhealth.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 nameMH002
    D.3.2Product code [MH002]
    D.3.4Pharmaceutical form Gastro-resistant 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.3.9.2Current sponsor codeMH002
    D.3.9.4EV Substance CodeSUB241149
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/g colony forming unit(s)/gram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100000000000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.3.11.13.1Other medicinal product typeLive Biotherapeutic Product
    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
    Acute Pouchitis
    Pouchite Acuta
    E.1.1.1Medical condition in easily understood language
    Acute Pouchitis
    Pouchite Acuta
    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 10036463
    E.1.2Term Pouchitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety of MH002 in Acute Pouchitis subjects
    Valutare la sicurezza di MH002 in soggetti con Pouchite Acuta
    E.2.2Secondary objectives of the trial
    To assess the mechanistic and clinical effects of MH002
    Valutare gli effetti meccanicistici e clinici di MH002
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged =18 years and =75 years
    2. Documented history of RPC with IPAA for UC performed at least 12 months prior to enrollment
    3. Confirmed diagnosis of Acute Pouchitis at Screening as defined by a modified Pouchitis Disease Activity Index (mPDAI) total score =5 and a mPDAI endoscopic subscore of =2 with symptoms not lasting >4 weeks
    4. Females of childbearing potential must not be pregnant or lactating and must agree to take an acceptable effective (or highly effective) contraceptive method of birth control during the study
    5. Written informed consent
    1. Soggetti di ambo i sessi, di età =18 anni e =75 anni
    2. Storia documentata di proctocolectomia restaurativa con IPAA per colite ulcerosa, eseguita almeno 12 mesi prima dell’arruolamento
    3. Diagnosi confermata di pouchite acuta allo Screening, determinata in base a un punteggio totale mPDAI (modified Pouchitis Disease Activity Index) =5 e un sottopunteggio endoscopico mPDAI =2, con durata dei sintomi non superiore a 4 settimane
    4. Le donne in età fertile non devono essere in stato di gravidanza o allattare al seno, e devono acconsentire ad utilizzare un metodo contraccettivo efficace (oppure altamente efficace) accettabile nel corso dello studio
    5. Consenso informato scritto
    E.4Principal exclusion criteria
    1. Chronic Pouchitis (=4 weeks of active Pouchitis) or antibiotic refractory Pouchitis
    2. Pelvic sepsis, acroscopic ulceration(s) of the pouch exclusively on the IPAA anastomotic line, anal sphincter dysfunction, Crohn's Disease of the pouch (known or suspected), Irritable Pouch Syndrome, isolated cuffitis, clinically significant pouch complications (stricture, fistula, anastomotic leak), diverting stoma, fecal incontinence
    3. Evidence of systemic impact of Pouchitis, bacteremia or sepsis, fever (>37.8°C), or any active infection of the gastrointestinal (GI) tract (e.g., Clostridium difficile, Salmonella, Shigella, Yersinia, Campylobacter, Escherichia coli, Giardia lamblia, Cryptosporidium, Vibrio, Aeromonas, and Plesiomonas)
    4. Medical history of any GI cancer
    5. Any uncontrolled or unstable disorder (at the Investigator's discretion, e.g., unstable Primary Sclerosing Cholangitis), including any clinically significant abnormality identified at Screening (e.g., safety lab parameters, physical exam) that may, according to the Investigator, put the subject at risk or interfere with the study procedures or reliability of study assessments to be done
    6. Prior use (since IPAA) of any biological treatment, including ustekinumab, anti-TNF agents (e.g., infliximab or adalimumab) or antiintegrin antibodies (e.g., vedolizumab), or treatment with small molecules such as ozanimod or any Janus kinase inhibitor (e.g., tofacitinib)
    7. Use of any topical treatment <4 weeks, any treatment with DiseaseModifying Antirheumatic Drugs (DMARDs) or other immunosuppressants, antibiotics, prebiotics or probiotics, or any investigational treatment <8 weeks, or Fecal Microbiota Transplantation <12 weeks prior to the Screening pouch endoscopy
    8. Concomitant use, during the study, of any prohibited medication: any anti-inflammatory agents (e.g., 5-ASA or systemically available corticosteroids), biologicals, immunosuppressants, DMARDs, Live Biotherapeutic Products (LBPs, other than MH002), probiotics, prebiotics, antibiotics, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (low dose aspirin excepted), investigational medicinal product (other than MH002) or investigational medical device, opioids or any rectally administered medication
    9. Conditions linked to severe immunosuppression (e.g., related to human immunodeficiency virus, malignancies, liver cirrhosis, systemic chemotherapy)
    10. 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,
    -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
    11. Any contraindication for pouch endoscopy
    12. Subject not being able, according to the Investigator, to reliably meet study requirements, e.g., planned major surgery or travelling during the study, or alcohol/illicit drug dependence
    1. Pouchite cronica (=4 settimane di pouchite in fase attiva) oppure pouchite refrattaria al trattamento antibiotico
    2. Sepsi pelvica, una o più ulcerazioni macroscopiche della pouch esclusivamente a carico dei monconi anastomotici dell’ileo pouch ano anastomosi, disfunzione dello sfintere anale, malattia di Crohn a carico della pouch (nota o sospetta), Sindrome della Pouch Irritabile, cuffite isolata, complicanze clinicamente significative a carico della pouch (stenosi, fistole, incontinenza dell’anastomosi), stomia per diversione fecale, incontinenza fecale
    3. Evidenza di impatto sistemico causato da pouchite, batteriemia o sepsi, febbre (>37,8°C), oppure qualsiasi infezione attiva del tratto gastrointestinale (GI) (es., Clostridium difficile, Salmonella, Shigella, Yersinia, Campylobacter, Escherichia coli, Giardia lamblia, Cryptosporidium, Vibrio, Aeromonas, e Plesiomonas)
    4. Storia di qualsiasi neoplasia maligna a carico del tratto GI
    5. Qualsiasi condizione non controllata o instabile (secondo il giudizio del medico sperimentatore, es., colangite sclerosante primitiva instabile), compresa qualsiasi anomalia clinicamente significativa identificata allo Screening (es, parametri di laboratorio per valutare la sicurezza, esame obiettivo) che potrebbe, a giudizio del medico sperimentatore, porre il soggetto a rischio oppure interferire con le procedure dello studio o con l’affidabilità delle valutazioni da eseguire per lo studio
    6. Uso pregresso (successivo all’esecuzione di IPAA) di qualsiasi trattamento biologico, compresi ustekinumab, agenti anti-TNF (es., infliximab o adalimumab) oppure anticorpi anti-integrina (es., vedolizumab), oppure trattamento con piccole molecole, quali ozanimod o qualsiasi inibitore delle Janus chinasi (es., tofacitinib)
    7. Uso di qualsiasi trattamento topico da <4 settimane, qualsiasi trattamento con farmaci antireumatici modificanti la malattia (Disease-Modifying-Antirheumatic Drugs, DMARDs) o altri immunosoppressori, antibiotici, prebiotici o probiotici, oppure qualsiasi trattamento sperimentale da <8 settimane, oppure trapianto di microbiota fecale <12 settimane prima dell’endoscopia della pouch allo Screening
    8. Uso concomitante, in corso di studio, di qualsiasi medicinale proibito: qualsiasi agente antinfiammatorio (es., 5-ASA o corticosteroidi disponibili per via sistemica), biologici, immunosoppressori, DMARDs, Prodotti bioterapeutici vivi (Live Biotherapeutic Products, LBP, diversi da MH002), probiotici, prebiotici, antibiotici, farmaci antinfiammatori non steroidei (FANS) (ad eccezione dell’aspirina a basso dosaggio), prodotti medicinali sperimentali (diversi da MH002) oppure dispositivo medico sperimentale, oppioidi o qualsiasi medicinale somministrato per via rettale
    9. Condizioni correlate a immunosoppressione grave (es, correlate al virus dell’immunodeficienza umana, neoplasie maligne, cirrosi epatica, chemioterapia sistemica)
    10. Aumentato rischio di sviluppare endocardite infettiva, fra cui:
    - Protesi valvolari cardiache compreso impianto transcatetere della protesi e omograft,
    - Uso di materiale protesico per la riparazione di valvola cardiaca quali ad esempio anelli e corde per annuloplastica
    - Endocardite infettiva pregressa,
    - Cardiopatia congenita cianotica non riparata oppure cardiopatia congenita riparata, con shunt residuo o rigurgito valvolare nel sito di un patch protesico o dispositivo protesico, o in un sito adiacente
    11. Qualsiasi controindicazione all’endoscopia della pouch
    12. Soggetto che non è in grado, a giudizio del medico sperimentatore, di attenersi in maniera affidabile ai requisiti dello studio, ad esempio interventi chirurgici maggiori o viaggi programmati durante il periodo di studio, o abuso di alcolici/dipendenza da stupefacenti
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of treatment-emergent Adverse Events (AEs) and treatmentemergent Adverse Reactions (ARs), i.e., AEs occurring after treatment initiation that are considered to be at least possibly associated with MH002 treatment.
    • Laboratory safety parameters: hematology (platelet and RBC count, hemoglobin, hematocrit, WBC count & differential), chemistry (ALT, AST, GGT, LDH, ALP, bilirubin, creatinine, urea, uric acid, albumin, glucose, CRP, total cholesterol, triglycerides, creatin kinase, ionogram (Na, K, Ca, Cl, Phosphate)), urinalysis (blood, protein, glucose, pH (microscopy if clinically indicated)). Clinically significant lab abnormalities will be recorded as AEs
    • Incidenza di Eventi Avversi (AE) emergenti con il trattamento e Reazioni Avverse (AR) emergenti con il trattamento, ovvero, AE che si manifestano dopo l’inizio del trattamento e sono considerati come almeno possibilmente associati al trattamento con MH002
    • Parametri di laboratorio per la valutazione della sicurezza: ematologia (conta di piastrine e di globuli rossi, emoglobina, ematocrito, conta dei globuli bianchi e formula differenziale), profilo biochimico (ALT, AST, GGT, LDH, fosfatasi alcalina, bilirubina, creatinina, urea, acido urico, albumina, glicemia, proteina C-reattiva, colesterolo totale, trigliceridi, creatinfosfochinasi, elettroliti [Na, K, Ca, Cl, fosfato]), analisi delle urine (sangue, proteine, glucosio, pH [esame microscopico, se clinicamente indicato]). Le alterazioni di laboratorio clinicamente significative verranno registrate come AE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1, 2, 3, 4, 5 and 4 Safety follow-up phone calls
    Visite 1, 2, 3, 4, 5 e 4 telefonate di follow-up per la valutazione della sicurezza
    E.5.2Secondary end point(s)
    Blood and fecal inflammatory markers, including CRP, TNF-a, interleukin (IL)-1ß, IL-6 and IL-10 in blood and fecal calprotectin.; Histological assessment of mucosal biopsies using the PDAI histology and Geboes scoring system.; Differential expression of genes involved in the maintenance of mucosal barrier integrity and those involved in the modulation of inflammation and immunity; Modified Pouchitis Disease Activity Index (mPDAI) total score, assessing signs and symptoms, and macroscopic appearance of mucosa for inflammation during endoscopy (using Mayo's Stool Frequency scores).; mPDAI subscores, i.e., endoscopic mucosal appearance, (Mayo) stool frequency, rectal bleeding, fecal urgency/abdominal cramps, fever.; Total number of ulcerations observed during endoscopy.; Rate of "clinical response", defined as a mPDAI total score <5 and a decrease of =2 on the mPDAI total score at week 8.; Rate of "clinical remission", defined as a mPDAI total score <5, a decrease of =2 in mPDAI total score, and a mPDAI endoscopic score <2 at week 8.; Physician's Global Assessment (PGA).; Severity of urgency based on Urgency Scoring Scale (USS) (diary).; Daily (24h) stool frequency count (diary).
    Marcatori infiammatori ematici e fecali, compresi PCR, TNF-a, interleuchina (IL)-1ß, IL-6 e IL-10 nel sangue, e calprotectina fecale; Valutazione istologica di biopsie di mucosa usando il dominio istologico del PDAI e l’indice Geboes; Espressione differenziale di geni coinvolti nel mantenimento dell’integrità della barriera mucosale, e di quelli coinvolti nella modulazione dell’infiammazione e immunità; Punteggio totale mPDAI, per la valutazione dei sintomi, e aspetto macroscopico della mucosa per rilevare la presenza di infiammazione durante l’endoscopia (in base ai punteggi Mayo relativi alla frequenza delle evacuazioni intestinali); Sottopunteggi mPDAI, ovvero item relativi all’aspetto endoscopico della mucosa, frequenza delle evacuazioni intestinali (Mayo), sanguinamento rettale, urgenza fecale/crampi addominali, febbre; Numero totale di ulcerazioni osservate durante l’endoscopia; Tasso di “risposta clinica”, definita quale punteggio totale mPDAI <5 e riduzione =2 punti del punteggio totale mPDAI alla Settimana 8; Tasso di “remissione clinica”, definita quale punteggio totale mPDAI <5, riduzione =2 punti del punteggio totale mPDAI e un sottopunteggio endoscopico mPDAI <2 alla Settimana 8; Valutazione globale da parte del medico (Physician’s Global Assessment, PGA); Gravità dell’urgenza in base allo strumento USS (Urgency Scoring Scale) (diario); Conta giornaliera (24 ore) delle evacuazioni intestinali (diario)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1, 2, 3, 4 and 5; Screening (Visit 1) and week 8 (Visit 5); Visit 1, 2, 3, 4 and 5; Visit 1, 2, 3, 4 and 5; Visit 1, 2, 3, 4 and 5; Screening (Visit 1) and week 8 (Visit 5); At week 8 (Visit 5); At week 8 (Visit 5); Screening (Visit 1), Day 1 (Visit 2), week 2 (Visit 3), week 4 (Visit 4) and week 8 (Visit 5); Visit 1, 2, 3, 4 and 5; Visit 1, 2, 3, 4 and 5
    Visite 1, 2, 3, 4, e 5; Screening (Visita 1) e settimana 8 (Visita 5); Visita 1, 2, 3, 4 e 5; Visite 1, 2, 3, 4, e 5; Visite 1, 2, 3, 4 e 5; Screening (Visita 1) e settimana 8 (Visita 5); Alla settimana 8 (visita 5); Alla settimana 8 (Visita 5); Screening (Visita 1), Day 1 (Visita 2), settimana 2 (Visita 3), settimana 4 (Visita 4) e settimana 8 (Visita 5); Visite 1, 2, 3, 4, e 5; Visite 1, 2, 3, 4, e 5
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 trial1
    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 EEA5
    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 Information not present in EudraCT
    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
    LVLS
    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 months4
    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 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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    None
    Nessuno
    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 Decision2022-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-14
    P. End of Trial
    P.End of Trial StatusOngoing
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