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    Summary
    EudraCT Number:2020-003884-25
    Sponsor's Protocol Code Number:4202-HEM-301
    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:2021-08-30
    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 number2020-003884-25
    A.3Full title of the trial
    An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral FT-4202, a Pyruvate Kinase Activator in Patients with Sickle Cell Disease
    Studio multicentrico, adattivo, randomizzato, in doppio cieco e controllato con placebo su FT-4202 per via orale, un attivatore della piruvato chinasi, in pazienti con anemia falciforme
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study is a randomized, placebo-controlled, double-blind, multicenter Phase 2/3 study of patients, age 12 to 65 years, with sickle cell disease (SCD).
    Studio di fase 2/3 multicentrico, adattivo, randomizzato, in doppio cieco in pazienti dai 12 ai 65 anni di età con anemia falciforme
    A.3.2Name or abbreviated title of the trial where available
    Hibiscus
    Hibiscus
    A.4.1Sponsor's protocol code number4202-HEM-301
    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 SponsorFORMA THERAPEUTICS, 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 supportForma Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationForma Therapeutics, Inc.
    B.5.2Functional name of contact pointFitzroy Dawkins, MD
    B.5.3 Address:
    B.5.3.1Street Address500 Arsenal Street, Suite 100
    B.5.3.2Town/ cityWatertown
    B.5.3.3Post codeMA 02742
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16097517258
    B.5.6E-mail4202medicalmonitor@formatherapeutics.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 numberEMA-OD-0000033107
    D.3 Description of the IMP
    D.3.1Product nameFT-4202
    D.3.2Product code [FT-4202]
    D.3.4Pharmaceutical form Tablet
    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 codeFT-4202
    D.3.9.3Other descriptive name(S)-1-(5-((2,3-dihydro-[1,4]dioxino[2,3-b]pyridin-7-yl)sulfonyl)-3,4,5,6-tetrahydropyrrolo[3,4-c]pyrrol-2(1H)-yl)-3-hydroxy-2-phenylpropan-1-one
    D.3.9.4EV Substance CodeSUB207913
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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 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 numberEMA-OD-0000033107
    D.3 Description of the IMP
    D.3.1Product nameFT-4202
    D.3.2Product code [FT-4202]
    D.3.4Pharmaceutical form Tablet
    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 codeFT-4202
    D.3.9.3Other descriptive name(S)-1-(5-((2,3-dihydro-[1,4]dioxino[2,3-b]pyridin-7-yl)sulfonyl)-3,4,5,6-tetrahydropyrrolo[3,4-c]pyrrol-2(1H)-yl)-3-hydroxy-2-phenylpropan-1-one
    D.3.9.4EV Substance CodeSUB207913
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboTablet
    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
    Sickle cell disease (SCD)
    Anemia falciforme
    E.1.1.1Medical condition in easily understood language
    Sickle cell disease (SCD)
    Anemia falciforme
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10040644
    E.1.2Term Sickle cell disease
    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 assess the efficacy of FT-4202 in adolescents and adults with SCD as compared to placebo as measured by improvement in hemoglobin (Hb)
    • To assess the efficacy of FT-4202 as compared to placebo on the annualized vaso-occlusive crisis (VOC) rate
    • Valutare l’efficacia di FT-4202 in adolescenti e adulti affetti da AF rispetto al placebo, misurata come miglioramento del contenuto di emoglobina (Hb)
    • Valutare l’efficacia di FT-4202 rispetto al placebo sul tasso annualizzato di crisi vaso-occlusive (CVO)
    E.2.2Secondary objectives of the trial
    • To measure the effects of FT-4202 on clinical measures and sequelae of hemolysis
    • To evaluate the effects of FT-4202 on the sequelae of VOC
    • To assess changes in fatigue of sickle cell patients taking FT-4202
    • Misurare gli effetti di FT-4202 su misure cliniche e sequele di emolisi
    • Valutare gli effetti di FT-4202 sulle sequele di CVO
    • Valutare i cambiamenti nella sensazione di affaticamento dei pazienti con anemia falciforme che assumono FT-4202
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Provision of consent
    2) Patient has a confirmed diagnosis of sickle cell disease
    3) At least 2 episodes of vaso-occlusive crises in the past 12 months
    4) Hemoglobin = 5.5 and = 10 g/dL (= 55 and = 100 g/L) during screening
    5) Patients taking hydroxyurea, must demonstrate a stable dose for at least 90 days prior to start of study treatment
    6) Female patients of childbearing potential must use highly effective methods of contraception, male patients are willing to use barrier methods of contraception
    1) Fornitura del consenso informato
    2) Il paziente ha una diagnosi confermata di malattia falciforme
    3) Almeno 2 episodi di crisi vaso-occlusive negli ultimi 12 mesi
    4) Emoglobina = 5,5 e = 10 g/dl (= 55 e = 100 g/L) durante lo screening
    5) I pazienti che assumono idrossiurea devono dimostrare una dose stabile per almeno 90 giorni prima dell'inizio del trattamento in studio
    6) Le pazienti di sesso femminile in età fertile devono utilizzare misure contraccettive altamente efficaci, i pazienti di sesso maschile devono essere disposti a utilizzare misure contraccettive di barriera
    E.4Principal exclusion criteria
    Medical Conditions
    1) More than 10 vaso-occlusive crises within the past 12 months
    2) Female who is breast feeding or pregnant
    3) Hepatic dysfunction characterized by:
    - Alanine aminotransferase (ALT) > 4.0 × upper limit of normal (ULN)
    - Direct bilirubin > 3.0 × ULN
    4) Known HIV positive
    5) Active hepatitis B or hepatitis C infection
    6) Severe renal dysfunction or on chronic dialysis
    7) History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including but not limited to the following:
    - Unstable angina pectoris or myocardial infarction or elective coronary intervention
    - Congestive heart failure requiring hospitalization
    - Uncontrolled clinically significant arrhythmias
    - Symptomatic pulmonary hypertension
    8) History of overt clinical stroke within previous 2 years or any history of an intracranial hemorrhage
    Prior/Concomitant Therapy
    1) Patients receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion)
    2) Receiving or use of concomitant medications that are strong inducers or moderate/strong inhibitors of CYP3A4/5 within 2 weeks of starting study treatment or anticipated need for such agents during the study
    3) Use of voxelotor within 28 days prior to starting study treatment or anticipated need for this agent during the study
    4) Use of a selectin antagonist (eg, crizanlizumab or other monoclonal antibody or small molecule) within 28 days of starting study treatment or anticipated need for such agents during the study
    5) Use of erythropoietin or other hematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study
    6) Receipt of prior cellular-based therapy (eg, hematopoietic cell transplant, gene modification therapy)
    Condizioni mediche
    1) Più di 10 crisi vaso-occlusive negli ultimi 12 mesi
    2) Sggetto di sesso femminile che allatta o è incinta
    3) Disfunzione epatica caratterizzata da:
    - Alanina aminotransferasi (ALT) > 4,0 × limite superiore del normale (ULN)
    - Bilirubina diretta > 3,0 × ULN
    4) Soggetto noto come HIV-positivo
    5) Infezione attiva da epatite B o C
    6) Grave disfunzione renale o in dialisi cronica
    7) Storia di malattia cardiaca o polmonare instabile o in deterioramento nei 6 mesi precedenti il consenso, tra cui:
    - Angina pectoris instabile o infarto miocardico o intervento coronarico elettivo
    - Insufficienza cardiaca congestizia che richiede l'ospedalizzazione
    - Aritmie clinicamente significative non controllate
    - Ipertensione polmonare sintomatica
    8) Storia di ictus clinico manifesto nei 2 anni precedenti o qualsiasi storia di emorragia intracranica
    Terapia precedente/comitante
    1) Pazienti che ricevono regolarmente una terapia trasfusionale (RBC) programmata (definita anche trasfusione cronica, profilattica o preventiva)
    2) Ricezione o uso di farmaci concomitanti che sono forti induttori o moderati/forte inibitori del CYP3A4/5 entro 2 settimane dall'inizio del trattamento di studio o necessità prevista di tali agenti durante lo studio
    3) Uso di voxelotor nei 28 giorni precedenti l'inizio del trattamento dello studio o necessità prevista di questo agente durante lo studio
    4) Uso di un antagonista della selectina (es. crizanlizumab o altro anticorpo monoclonale o piccola molecola) entro 28 giorni dall'inizio del trattamento dello studio o necessità prevista di tali agenti durante lo studio
    5) Uso di eritropoietina o altro trattamento con fattore di crescita ematopoietico entro 28 giorni dall'inizio del trattamento dello studio o necessità prevista di tali agenti durante lo studio
    6) Ricezione di una precedente terapia a base di cellule (es. trapianto di cellule ematopoietiche, terapia di modificazione genica)
    E.5 End points
    E.5.1Primary end point(s)
    • Hb response rate at Week 24 (increase of > 1 g/dL [> 10 g/L] from baseline) during the blinded treatment period
    • Annualized VOC rate during the 52-week blinded treatment period based on adjudicated VOC review
    • Tasso di risposta dell’Hb alla Settimana 24 (aumento di >1 g/dl [>10 g/l] rispetto al basale) durante il periodo di trattamento in cieco
    • Tasso di CVO annualizzato durante il periodo di trattamento in cieco di 52 settimane in base alla revisione delle CVO stabilita
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Hemoglobin response rate at Week 24 (increase of > 1 g/dL [> 10 g/L] from baseline) during the blinded treatment period [ Time Frame: 24 Weeks ]
    2. Annualized vaso-occlusive crisis rate during the 52-week blinded treatment period based on adjudicated vaso-occlusive crisis review [ Time Frame: 52 Weeks ]
    • Tasso di risposta dell’Hb alla Settimana 24 (aumento di >1 g/dl [>10 g/l] rispetto al basale) durante il periodo di trattamento in cieco: 24 settimane
    • Tasso di CVO annualizzato durante il periodo di trattamento in cieco di 52 settimane in base alla revisione delle CVO stabilita: 52 settimane
    E.5.2Secondary end point(s)
    • Change from baseline in Hb at Week 24 during the blinded treatment period
    • Change in SCD-related clinical laboratory measurements from baseline at Week 24 during the blinded treatment period in:
    o % reticulocytes,
    o Unconjugated bilirubin, and
    o Lactate dehydrogenase (LDH)
    • Time to first VOC during the blinded treatment period
    • Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale at Week 24 during the blinded treatment period; • Variazione rispetto al basale dell’Hb alla Settimana 24 durante il periodo di trattamento in cieco
    • Cambiamento delle misurazioni cliniche di laboratorio relative all’AF, rispetto al basale, alla Settimana 24 durante il periodo di trattamento in cieco:
    o % di reticolociti,
    o bilirubina non coniugata, e
    o lattato deidrogenasi (LDH)
    • Tempo alla prima CVO durante il periodo di trattamento in cieco
    • Variazione rispetto al basale nei punteggi della scala dell’affaticamento del Sistema informativo per la misurazione degli esiti riferiti dal paziente (PROMIS) alla Settimana 24, durante il periodo di trattamento in cieco
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Change from baseline in hemoglobin at W24 during the blinded treatment period [Time Frame: 24 Weeks]
    2. Change in SCD related clinical lab measurements from baseline at W24 during the blinded treatment period [Time Frame: 24 Weeks]
    - % reticulocytes; Unconjugated bilirubin; Lactate dehydrogenase
    3. Time to first vaso-occlusive during the blinded treatment period [Time Frame: 52 Weeks]
    4. Change from baseline in PROMIS) Fatigue Scale at W24 during the blinded treatment period [Time Frame: 24 Weeks]
    Adult patients (18 to 65) will complete the PROMIS® Item Bank v.1.0 - Fatigue - Short Form 7a. Adolescent patients (12 to 17) will complete the PROMIS® Item Bank v2.0 - Fatigue - Short Form 10a. Responses are graded on a score of 1 to 5 with a higher score indicating a worse outcome.; • Variaz
    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) Yes
    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 trial4
    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 EEA29
    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
    Canada
    United States
    France
    Germany
    Italy
    Spain
    United Kingdom
    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 years2
    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 years2
    E.8.9.2In all countries concerned by the trial months2
    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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 302
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 94
    F.4.2.2In the whole clinical trial 344
    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)
    Once patients complete the Phase 2/3 blinded portions of the trial, an open-label extension is available for patients continuing to derive benefit as determined by their physician. Expanded access may be available until marketing approval or discontinuation of the development program.
    I soggetti che completano il periodo di trattamento di fase 2/3 in doppio cieco che continuano a trarre beneficio del trattamento, secondo il giudizio del loro medico, possono accedere alla fase di estensione in aperto. Un accesso più esteso potrebbe essere possibile fino all'approvazione della commercializzazione o all'interruzione del programma di sviluppo.
    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 Decision2021-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-23
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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