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    Summary
    EudraCT Number:2020-002855-40
    Sponsor's Protocol Code Number:REN001-201
    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:2021-06-08
    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 number2020-002855-40
    A.3Full title of the trial
    A DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 24 WEEKS TREATMENT WITH REN001 IN PATIENTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM)
    STUDIO IN DOPPIO CIECO, CONTROLLATO CON PLACEBO PER VALUTARE L’EFFICACIA E LA SICUREZZA DI 24 SETTIMANE DI TRATTAMENTO CON REN001 IN PAZIENTI AFFETTI DA MIOPATIA MITOCONDRIALE PRIMARIA (PMM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To study the effectiveness and safety of REN001 in PMM patients after 24 weeks of treatment
    Studio dell'efficacia e sicurezza di REN001 in pazienti affetti da PMM dopo 24 settimane di trattamento
    A.3.2Name or abbreviated title of the trial where available
    Phase 2b Safety and Efficacy Study of REN001 in Primary Mitochondrial Myopathy
    Studio di fase 2b di efficacia e sicurezza di REN001 nella miopatia mitocondriale primaria
    A.4.1Sponsor's protocol code numberREN001-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04535609
    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 SponsorReneo Pharma LTD
    B.1.3.4CountryUnited Kingdom
    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 supportReneo Pharma Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReneo Pharma Ltd
    B.5.2Functional name of contact pointDr. Lynn Purkins
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, Discovery Park, Ramsgate Road
    B.5.3.2Town/ citySandwich, Kent
    B.5.3.3Post codeCT13 9FF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441304809360
    B.5.6E-maillpurkins@reneopharma.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 Yes
    D.2.5.1Orphan drug designation number EU/3/20/2311
    D.3 Description of the IMP
    D.3.1Product nameREN001
    D.3.2Product code [REN001]
    D.3.4Pharmaceutical form Capsule, hard
    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 codeREN001
    D.3.9.3Other descriptive nameSodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop-1-ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 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, hard
    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
    Primary Mitochondrial Myopathy
    Miopatia mitocondriale primaria
    E.1.1.1Medical condition in easily understood language
    Group of disorders associated with changes in genetic material found within the DNA of mitochondria (mtDNA) or in genes outside the mitochondria (nuclear DNA), mainly affecting the skeletal muscle
    Gruppo di malattie associate a mutazioni nel DNA mitocondriale (mtDNA) o in geni fuori dal mitocondrio (DNA nucleare), che colpiscono primcipalmente il muscolo scheletrico
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027710
    E.1.2Term Mitochondrial myopathy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 evaluate the efficacy of REN001 in subjects with PMM treated for 24 weeks, assessed by the effect on exercise endurance.
    Valutare l’efficacia di REN001 in soggetti con PMM trattati per 24 settimane, determinata in base all’effetto sulla resistenza all’esercizio fisico.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of REN001 in subjects with PMM treated for 24 weeks, assessed by the effect on fatigue.
    Valutare l’efficacia di REN001 in soggetti con PMM trattati per 24 settimane, determinata in base all’effetto sull’affaticamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects aged 18 years or older with PMM
    2. A confirmed PMM diagnosis due to known pathogenic gene mutation or deletion of the mitochondrial genome.
    3. Documented PMM primarily characterized by exercise intolerance or active muscle pain.
    4. Subjects must be ambulatory and able to perform the 12MWT independently (walking aids are allowed).
    5. Distance walked of <=1000 meters at Screening in the 12MWT (must be obtained at least 4 weeks before randomization).
    6. Have no changes to any therapeutic exercise regimen within 30 days prior to Day 1 and be willing to remain on the same therapeutic exercise regimen for the duration of the study.
    7. Be willing and able to swallow gelatin capsules.
    8. Females should be either of non-child-bearing potential or must agree to use highly effective methods of contraception from Screening through to 30 days after last dose in the study. Where females are using hormonal contraception therapy, an additional effective non-hormonal method of contraception is advised. Males with partners who are WOCBP must also use contraception.
    9. Concomitant medications (including supplements) must be stable for at least 1 month prior to enrolment and throughout participation in the study.
    10. For subjects under 25 years of age, confirmation of bone growth plate closure by wrist radiograph
    11. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
    1. Soggetti di età =18 anni affetti da PMM
    2. Una diagnosi confermata di PMM dovuta a una mutazione o delezione genica patogena nota del genoma mitocondriale.
    3. PMM documentata caratterizzata principalmente da intolleranza all’esercizio fisico o dolore muscolare in fase attiva.
    4. I soggetti devono essere in grado di deambulare ed eseguire il test 12MWT in modo indipendente (è consentito l’uso di ausili per la deambulazione).
    5. Distanza percorsa <=1.000 metri allo screening durante il test 12MWT (la misurazione deve essere effettuata almeno 4 settimane prima della randomizzazione).
    6. Il soggetto non deve aver apportato modifiche ad alcun regime di esercizio fisico terapeutico nei 30 giorni precedenti al Giorno 1 ed essere disposto a proseguire lo stesso regime di esercizio fisico terapeutico per la durata dello studio.
    7. Disponibilità e capacità di deglutire le capsule di gelatina.
    8. I soggetti di sesso femminile non devono essere in età fertile oppure devono accettare di usare metodi contraccettivi altamente efficaci a partire dallo screening fino a 30 giorni dopo l’ultima dose nello studio. Se i soggetti di sesso femminile utilizzano una terapia di contraccezione ormonale, si raccomanda un ulteriore metodo di contraccezione efficace non ormonale. Anche i soggetti di sesso maschile con partner che sono donne in età fertile (Women Of Child-Bearing Potential, WOCBP) devono utilizzare un metodo contraccettivo.
    9. I farmaci concomitanti (compresi gli integratori) destinati al trattamento di PMM o di altre comorbilità devono rimanere stabili per almeno un mese prima della randomizzazione e per tutta la partecipazione allo studio.
    10. Solamente per i soggetti di età <25 anni: conferma della chiusura della cartilagine di accrescimento osseo mediante radiografia del polso.
    11. Possesso di un documento di consenso informato personalmente firmato e datato, attestante che il soggetto è stato informato su tutti gli aspetti pertinenti dello studio.
    E.4Principal exclusion criteria
    1. Participation in a prior REN001 study.
    2. Currently taking or anticipated to need a PPAR agonist during the study.
    3. Bone deformities or motor abnormalities other than related to the mitochondrial myopathy that may interfere with the outcome measures.
    4. Treatment with an investigational drug within 3 months or 5 drug half-lives, whichever is longer, prior to Day 1.
    5. Anticipated to need a prescription and/or non-prescription drug that might interfere with the study endpoints
    6. Currently taking drugs with a narrow therapeutic index and BCRP mediated ADME
    7. Clinically significant kidney disease or impairment at Screening.
    8. Clinically significant liver disease or impairment of AST or ALT Grade 2 or above (>2.5 x ULN), or Total bilirubin > 1.6 x ULN or >ULN with other signs and symptoms of hepatotoxicity at Screening.
    9. Uncontrolled diabetes and/or a Screening HbA1c of >= 11%.
    10. Uncontrolled epilepsy.
    11. Evidence of significant concomitant clinical disease that may need a change in management during the study or could interfere with the conduct or safety of this study.
    12. A history of cancer. A history of in situ basal cell carcinoma in the skin is allowed.
    13. Have been hospitalized within the 3 months prior to Screening for any major medical condition (as deemed by the Investigator).
    14. Clinically significant cardiac disease and/or clinically significant ECG abnormalities including a screening QTcF >= 450 msec, 2nd degree heart block, symptomatic tachyarrhythmia or unstable arrythmia that in the opinion of the Investigator should exclude the subject from completing exercise tests (i.e. 12 MWT and 30 STS tests).
    15. Any condition possibly reducing drug absorption.
    16. Evidence of hospitalization for rhabdomyolysis within the year prior to enrolment.
    17. Positive HBsAg, HBcAb or hepatitis C or HIV at Screening.
    18. Pregnant or nursing females.
    19. History of sensitivity to PPAR agonists.
    20. Donation or intent to donate blood, or blood components during the study or within one month after completion of the study.
    21. A history of drug dependency.
    22. A history of alcohol dependency.
    23. Significant impairment due to central or peripheral nervous system involvement that would interfere with the exercise tests.
    24. Significant weakness not caused by the underlying primary muscle disease such as post stroke or neurogenic weakness.
    25. Have had an organ transplant.
    26. Are not eligible or have a contraindication for cataract surgery.
    27. A history of osteoporosis as evidenced by non-traumatic (stress) fractures or a prior T-score of -2.5 or worse which has not been adequately addressed.
    28. Inability to comprehend or unwilling to follow the study requirements including restrictions on treatments, attendance at the study center, completion of questionnaires and participation in laboratory testing as called for by the protocol.
    29. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator and in discussion with the Medical Monitor, would make the subject inappropriate for entry into this study.
    1. Partecipazione a un precedente studio di REN001.
    2. Terapia in corso o previsione di dover ricorrere a una terapia con un agonista del recettore attivato da proliferatori perossisomiali durante lo studio.
    3. Deformità ossee o anomalie motorie diverse da quelle correlate a miopatia mitocondriale che potrebbero interferire con le misure di esito.
    4. Trattamento con un farmaco sperimentale nei 3 mesi o nelle 5 emivite del farmaco, a seconda di quale periodo sia più lungo, precedenti al Giorno 1.
    5. Necessità prevista di ricorrere all’uso di un farmaco su prescrizione e/o da banco che potrebbe interferire con gli endpoint dello studio
    6. Assunzione attuale di farmaci con uno stretto indice terapeutico e assorbimento, distribuzione, metabolismo ed escrezione (ADME) mediati dalla proteine di resistenza del carcinoma mammario
    7. Nefropatia o insufficienza renale clinicamente significativa,allo screening.
    8. Epatopatia o insufficienza epatica clinicamente significativa con valori di AST o ALT >2,5 ULN, o bilirubina totale >1,6 x ULN o >ULN con altri segni e sintomi di epatotossicità allo screening.
    9. Diabete non controllato e/o un valore di emoglobina glicosilata (HbA1c) allo screening >= 11%.
    10. Epilessia non controllata.
    11. Evidenza di malattia clinica concomitante significativa che potrebbe richiedere una modifica nella gestione durante lo studio o che potrebbe interferire con la conduzione o la sicurezza di questo studio.
    12. Un’anamnesi di tumore. È consentita un’anamnesi di carcinoma cutaneo in situ a cellule basali.
    13. Ricovero in ospedale nei 3 mesi che precedono lo screening per qualsiasi condizione medica grave (in base al giudizio dello sperimentatore).
    14. Cardiopatia clinicamente significativa e/o anomalie ECG clinicamente significative compresi un QT corretto secondo la formula di Fridericia di screening >= 450 msec, blocco cardiaco di 2° grado, tachiaritmia sintomatica o aritmia instabile che, a giudizio dello sperimentatore, dovrebbero escludere il soggetto dall’esecuzione dei test dello studio sotto sforzo (per es. i test 12MWT e 30STS).
    15. Qualsiasi condizione potenzialmente in grado di ridurre l’assorbimento di farmaci
    16. Evidenza di ricovero ospedaliero per rabdomiolisi entro l’anno precedente l’arruolamento.
    17. Positività per HBsAg, HBcAb o infezione da epatite C o HIV allo screening.
    18. Donne in gravidanza o allattamento.
    19. Anamnesi di sensibilità agli agonisti di PPAR.
    20. Donazione o intenzione di donare sangue o componenti ematici durante lo studio o entro un mese dal completamento dello studio.
    21. Un’anamnesi di tossicodipendenza.
    22. Un’anamnesi di dipendenza da alcol.
    23. Significativo deterioramento dovuto al coinvolgimento del sistema nervoso centrale o periferico che potrebbe interferire con i test sotto sforzo.
    24. Debolezza significativa non causata dalla malattia muscolare primaria sottostante, come debolezza post-ictus o neurogena.
    25. Aver subìto un trapianto di organo.
    26. Non essere idonei o presentare una controindicazione a un intervento chirurgico per la cataratta.
    27. Un’anamnesi di osteoporosi, dimostrata da fratture non traumatiche (stress) o da un T-score precedente di -2,5 o peggiore che non è stato adeguatamente approfondito.
    28. Incapacità di comprendere o riluttanza ad attenersi ai requisiti dello studio, comprese le restrizioni sui trattamenti, la frequentazione del centro di studio, la compilazione dei questionari e la partecipazione agli esami di laboratorio richiesti dal protocollo.
    29. Qualsiasi altra grave condizione medica o psichiatrica acuta o cronica o anomalia di laboratorio che possa aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del prodotto sperimentale o che possa interferire con l’interpretazione dei risultati dello studio e che, a giudizio dello sperimentatore e previa discussione con il responsabile del monitoraggio medico, possa rendere il soggetto non idoneo all’ammissione a questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in distance walked during the 12 minute walk test
    Variazione dal basale della distanza percorsa a piedi durante il test del cammino di 12 minuti (12-Minute Walk Test, 12MWT).
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 24 weeks
    settimana 24
    E.5.2Secondary end point(s)
    Change from Baseline in the Modified Fatigue Impact Scale (MFIS) Physical sub-scale score.
    Patient Global Impression of Change (PGIC) score (muscle symptoms).
    Variazione dal basale nel punteggio della sottoscala fisica della Scala modificata per la valutazione dell’impatto sull’affaticamento (Modified Fatigue Impact Scale, MFIS)
    Punteggio dell’Impressione globale del cambiamento da parte del paziente (Patient Global Impression of Change, PGIC) (sintomi muscolari).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from Baseline in the MFIS Physical sub-scale score:evaluation timepoint = 24 weeks
    PGIC score (muscle symptoms): evaluation timepoint = End of Treatment
    Variazione dal basale nel punteggio della sottoscala fisica della Scala modificata per la valutazione dell’impatto sull’affaticamento (Modified Fatigue Impact Scale, MFIS): settimana 24
    Punteggio dell’Impressione globale del cambiamento da parte del paziente (Patient Global Impression of Change, PGIC) (sintomi muscolari): fine del trattamento
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 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 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 concerned5
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    New Zealand
    United States
    United Kingdom
    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
    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 months3
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 200
    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 Decision2021-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-08
    P. End of Trial
    P.End of Trial StatusOngoing
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