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    Summary
    EudraCT Number:2021-001674-34
    Sponsor's Protocol Code Number:AG348-C-020
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-16
    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 ConcernedGermany - BfArM
    A.2EudraCT number2021-001674-34
    A.3Full title of the trial
    A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Mitapivat in Subjects With Sickle Cell Disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to check the Efficacy and Safety of Mitapivat in Patients with Sickle Cell Disease
    A.4.1Sponsor's protocol code numberAG348-C-020
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05031780
    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 SponsorAgios Pharmaceuticals, 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 supportAgios Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAgios Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointDirector, Scientific Communications
    B.5.3 Address:
    B.5.3.1Street Address88 Sidney Street
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139-4169
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18332288474
    B.5.6E-mailEx-USmedinfo@agios.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 nameMitapivat
    D.3.2Product code AG-348
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNMitapivat
    D.3.9.1CAS number 2151847-10-6
    D.3.9.2Current sponsor codeAG-348 sulfate hydrate
    D.3.9.3Other descriptive nameAGI-1480, AGX-0841, AG-348, AG-348 hemisulfate
    D.3.9.4EV Substance CodeSUB181978
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMitapivat
    D.3.2Product code AG-348
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNMitapivat
    D.3.9.1CAS number 2151847-10-6
    D.3.9.2Current sponsor codeAG-348 sulfate hydrate
    D.3.9.3Other descriptive nameAGI-1480, AGX-0841, AG-348, AG-348 hemisulfate
    D.3.9.4EV Substance CodeSUB181978
    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 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.IMP: 3
    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 nameMitapivat
    D.3.2Product code AG-348
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNMitapivat
    D.3.9.1CAS number 2151847-10-6
    D.3.9.2Current sponsor codeAG-348 sulfate hydrate
    D.3.9.3Other descriptive nameAGI-1480, AGX-0841, AG-348, AG-348 hemisulfate
    D.3.9.4EV Substance CodeSUB181978
    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 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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    E.1.1.1Medical condition in easily understood language
    Sickle cell disease is an inherited blood disorder where the red blood cells, which carry oxygen around the body, develop abnormally and become rigid and shaped like a crescent (sickle shape).
    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
    Phase 2)
    To determine the recommended Phase 3 dose of mitapivat by evaluating the effect of 2 dose levels of mitapivat versus placebo on:
    • Anemia in subjects with sickle cell disease (SCD)
    • Safety

    Phase 3)
    To determine the effect of mitapivat versus placebo on:
    • Anemia in subjects with sickle cell disease (SCD)
    • Sickle cell pain crises (SCPCs) in subjects with SCD
    E.2.2Secondary objectives of the trial
    Phase 2)
    To evaluate the effect of 2 doses of mitapivat versus placebo on:
    - Anemia
    - Markers of hemolysis and erythropoiesis
    - Patient-reported fatigue
    - Sickle cell pain crises (SCPCs).
    To evaluate the pharmacokinetic and pharmacodynamic effects of mitapivat.

    Phase 3)
    To evaluate the effect of mitapivat versus placebo on:
    • Anemia in subjects with SCD
    • Markers of hemolysis
    • Markers of erythropoiesis
    • Patient-reported fatigue
    • Additional clinical efficacy measures related to SCPC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • ≥18 years of age at the time of providing informed consent
    • Documented diagnosis of SCD (HbSS, HbSC, HbS/β0-thalassemia, HbS/β+ thalassemia, or other sickle cell syndrome variants).
    • At least 2 sickle cell pain crises (SCPCs) and no more than 10 SCPCs in the past 12 months.
    • Hemoglobin ≥5.5 and ≤10.5 g/dL.
    • If taking hydroxyurea, the hydroxyurea dose must be stable for at least 90 days before starting study drug. Discontinuation of hydroxyurea requires a 90-day washout prior to informed assent/consent.
    • Women capable of becoming pregnant and men with partners who are women that are capable of becoming pregnant must agree to use 2 forms of contraception.
    • Other protocol-defined inclusion criteria may apply.
    E.4Principal exclusion criteria
    • Pregnant or breastfeeding.
    • Receiving regularly scheduled transfusions.
    • Hospitalized for an SCPC and/or other vaso-occlusive event within 14 days prior to providing informed assent/consent or during the Screening Period. A hospitalization is defined as an in-patient admission to a hospital that may or may not be preceded by an emergency room or out patient clinic visit. A visit to an emergency room that does not result in an in-patient admission does not meet the definition of hospitalization
    • Currently receiving treatment for SCD (eg, voxelotor, crizanlizumab, L glutamine), with the exception of hydroxyurea. The last dose of voxelotor, crizanlizumab, and L-glutamine must have been administered at least 90 days before starting study drug.
    • Currently receiving treatment with hematopoietic stimulating agents; the last dose must have been administered at least 90 days before starting study drug.
    • Received treatment on another investigational trial within 90 days prior to start of study drug or plans to participate in another investigational drug trial.
    • Taking medications that are strong inhibitors of CYP3A4/5 or strong
    inducers of CYP3A4 that cannot be stopped in an acceptable timeframe
    before starting study drug (timeframe will be discussed with your
    doctor).
    • Other protocol defined exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 2 Primary Endpoints:
    • Percentage of participants with hemoglobin (Hb) response
    • Percentage of participants with treatment emergent adverse events (AEs) and treatment emergent serious adverse events (SAEs)

    Phase 3 Primary Endpoints
    • Percentage of participants with hemoglobin (Hb) response
    • Annualized rate of Sickle Cell Pain Crises (SCPCs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 2 primary endpoint of percentage of participants with Hb response: Week 12

    Phase 2 primary endpoint of percentage of participants with treatment emergent AEs and treatment emergent SAEs: Up to Week 12

    Phase 3 primary endpoint of percentage of participants with Hb response: Week 52

    Phase 3 primary endpoint of annualized rate of sickle cell pain crises: Up to Week 52
    E.5.2Secondary end point(s)
    Phase 2 Secondary Endpoints
    1. Change from baseline in Hb concentration
    2. Change from baseline in indirect bilirubin
    3. Change from baseline in lactate dehydrogenase (LDH)
    4. Change from baseline in absolute reticulocyte count
    5. Change from baseline in percent reticulocytes
    6. Change from baseline in erythropoietin
    7. Change from baseline in Patient-Reported Outcomes Measurement Information System® (PROMIS®) Fatigue 13a Short Form (SF) Score
    8. Annualized Rate of SCPCs
    9. Pharmacokinetic/Pharmacodynamic Relationship: Evaluate the Exposure of Mitapivat to the Change in Adenosine Triphosphate (ATP) and 2,3-Diphosphoglycerate (2,3-DPG)
    10. Mitapivat Concentration Over Time
    11. Mitapivat Area Under the Concentration-time curve
    12. Mitapivat Maximum (Peak) Concentration

    Phase 3 Secondary Endpoints
    1. Change From Baseline in Hb Concentration
    2. Change From Baseline in Indirect Bilirubin
    3. Change From Baseline in Percent Reticulocytes
    4. Change From Baseline in PROMIS® Fatigue 13a SF Scores
    5. Annualized Frequency of Hospitalizations for SCPC
    6. Change From Baseline in LDH Concentration
    7. Change From Baseline in Absolute Reticulocytes
    8. Change From Baseline in Erythropoietin
    9. Percentage of Participants With Improvement in the Patient Global Impression of Severity (PGIS) -Fatigue
    10. Percentage of Participants With Improvement in the Patient Global Impression of Change (PGIC) -Fatigue
    11. Time to First SCPC
    12. Time to Second SCPC
    13. Annualized Rate of Hospitalization Days for SCPC
    14. Annualized Rate of Emergency Room Visits for SCPC
    15. Change From Baseline in 6-Minute Walk Test (6MWT)
    16. Change From Baseline in PROMIS Pain Intensity
    17. Change From Baseline in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Impact
    18. PGIC of Pain
    19. Change From Baseline in PGIS of Pain
    20. Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious AEs (SAEs)
    21. Pharmacokinetic/Pharmacodynamic Relationship: Evaluate the Exposure of Mitapivat to the Change in ATP and 2,3-DPG Levels
    22: Mitapivat Concentration Over Time
    23: Mitapivat Area Under the Concentration Curve
    24: Mitapivat Maximum (Peak) Concentration
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase 2
    Endpoints #1,2,3,4,5,6,7: Baseline, Week 10 up to Week 12
    Endpoint #8: Up to Week 12
    Endpoints #9,10,11,12: Day 1 up to Week 8

    Phase 3
    Endpoints #1,2,3,4,6,7,8: Baseline, Week 24 up to Week 52
    Endpoint #5,11,12,13,14: Up to Week 52
    Endpoints #9,10: Baseline, Weeks 24, 28, 40, and 52
    Endpoints #15,18,19: Baseline, Week 52
    Endpoints #16,17: Baseline, Week 24 and 52
    Endpoint #20: Up to 56 weeks
    Endpoints #21,22,23,24: Day 1 up to Week 40
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.7.1Other trial design description
    There is an open label extension period following completion of the double blind period.
    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 trial3
    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 EEA24
    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
    Egypt
    Nigeria
    Oman
    Brazil
    Canada
    Israel
    Kenya
    Lebanon
    Saudi Arabia
    United Kingdom
    United States
    Belgium
    France
    Germany
    Italy
    Netherlands
    Türkiye
    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
    The end of the study is defined as the time at which all subjects complete all study visits, are lost to follow-up, have withdrawn consent for further participation in the study, or when the Sponsor terminates the study. Study completion is the date of the last visit of the last subject in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months10
    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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 96
    F.4.2.2In the whole clinical trial 267
    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
    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 Decision2022-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-05
    P. End of Trial
    P.End of Trial StatusOngoing
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