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    Summary
    EudraCT Number:2020-004029-21
    Sponsor's Protocol Code Number:INCB00928-104
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-09-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-004029-21
    A.3Full title of the trial
    A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
    A.4.1Sponsor's protocol code numberINCB00928-104
    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 SponsorIncyte Corporation
    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 supportIncyte corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.5Fax number13024252734
    B.5.6E-mailRegAffairs@incyte.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.3.2Product code INCB000928
    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 codeINCB000928
    D.3.9.3Other descriptive nameINCB000928 fumarate dihydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.3.2Product code INCB000928
    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 codeINCB000928
    D.3.9.3Other descriptive nameINCB000928 fumarate dihydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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 Yes
    D.2.1.1.1Trade name Jakavi
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRuxolitinib
    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.3.8INN - Proposed INNJakavi
    D.3.9.1CAS number 1092939-17-7
    D.3.9.3Other descriptive nameRUXOLITINIB PHOSPHATE
    D.3.9.4EV Substance CodeSUB32897
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anaemia associated with myelofibrosis whether as a de novo disorder (PMF) or evolve secondarily from previous PV or ET (post–PV MF or post–ET MF).
    E.1.1.1Medical condition in easily understood language
    Anaemia associated with myelofibrosis
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028537
    E.1.2Term Myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10074689
    E.1.2Term Post polycythemia vera myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10074690
    E.1.2Term Post essential thrombocythemia myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10074691
    E.1.2Term Post polycythaemia vera myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10074692
    E.1.2Term Post essential thrombocythaemia myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10077161
    E.1.2Term Primary myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and tolerability of INCB000928 administered as monotherapy (TGA) or in combination with ruxolitinib (TGB).
    E.2.2Secondary objectives of the trial
    To determine the efficacy of INCB000928 administered as monotherapy (TGA) or in combination with ruxolitinib (TGB).
    To evaluate the PK of INCB000928 administered as monotherapy (TGA) or in combination with ruxolitinib TGB).
    To evaluate the effect of INCB000928 administered as monotherapy (TGA) or in combination with ruxolitinib (TGB) on hepcidin level, iron homeostasis, and erythropoiesis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to comprehend and willingness to sign a written ICF for the study.
    2. Age 18 years or older at the time of signing the ICF.
    3. ECOG performance status score of the following:
    a. 0 or 1 for the dose-escalation stages.
    b. 0, 1, or 2 for the dose-expansion stage.
    4. Life expectancy is greater than 6 months.
    5. Agreement to undergo a pretreatment and regular on-study BM biopsies and aspirates (as
    appropriate to disease).
    6. Agreement to avoid pregnancy or fathering children based on the criteria below:
    a. Men must agree to take appropriate precautions to avoid fathering children (with at
    least 99% certainty) from screening through 90 days after the last study treatment
    dose and must refrain from donating sperm during this period.
    b. Women of childbearing potential must have a negative serum pregnancy test at
    screening before the first dose and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through the safety follow-up visit and must not donate oocytes during this period
    c. Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or
    bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age)
    are eligible.
    7. Participants with MF who are transfusion-dependent or present with symptomatic
    anemia, defined as follows:
    a. Anemia: An Hgb value < 10 g/dL demonstrated during screening recorded on
    3 separate occasions with at least 7 days between measurements
    b. Transfusion-dependent: Participant has received at least 4 units of RBC transfusions
    during the 28 days immediately preceding Cycle 1 Day 1 OR has received at least
    4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for
    an Hgb level of < 8.5 g/dL, in the absence of bleeding or treatment-induced anemia.
    In addition, the most recent transfusion episode must have occurred in the 28 days
    before Cycle 1 Day 1.
    8. Histologically confirmed diagnosis of PMF, post-PV, or post-ET MF according to the 2016 WHO criteria.
    9. Ineligible to receive or have not responded to available therapies for anemia such as
    ESAs.
    10. Participants with BM and peripheral blood myeloblast count < 10%.
    For TGA:
    11. Participants previously treated with JAK inhibitors (intolerant, resistant, refractory, or
    lost response to a JAK inhibitor) for at least 12 weeks.
    12. Participants with intermediate-2 or high DIPSS MF (according to IWG-MRT criteria).
    For TGB:
    13. Participants must have been on a therapeutic and stable regimen of ruxolitinib (ie, the
    dose and dose-regimen of ruxolitinib to treat the MF has not been modified at any time)
    for at least 12 consecutive weeks immediately preceding the first dose of study treatment.
    14. Participants with intermediate-1, intermediate-2, or high DIPSS MF (according to
    IWG-MRT criteria.
    E.4Principal exclusion criteria
    1. Undergone any prior allogenic or autologous stem cell transplantation or a candidate for
    such transplantation.
    2. Any major surgery within 28 days before the first dose of study treatment.
    3. Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy,
    biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating
    agent to treat the participant's disease, with the exception of ruxolitinib for TGB only,
    within 5 half-lives or 28 days (whichever is shorter) before the first dose of study
    treatment.
    4. Undergoing treatment with another investigational medication or having been treated
    with an investigational medication within 28 days before the first dose of study treatment.
    5. Undergoing treatment with a potent/strong inhibitor or inducer of CYP3A4/5 within
    28 days or 5 half-lives (whichever is longer) before the first dose of study treatment, or
    expected to receive such treatment during the study.
    6. Any prior radiation therapy within 28 days before the first dose of study treatment.
    7. Presence of any hematological malignancy other than PMF, post-PV, or post-ET MF, as
    applicable.
    8. Active invasive malignancy over the previous 5 years.
    9. Known active disease involving the CNS.
    10. History of clinically significant or uncontrolled cardiac disease, including recent (within
    the last 12 months) unstable angina or acute myocardial infarction, or New York Heart
    Association Class III or IV congestive heart failure, or clinically significant arrhythmias
    not controlled by medication.
    11. History or presence of an abnormal ECG that, in the investigator's opinion, is clinically
    meaningful.
    12. Presence of chronic or current active infectious disease requiring systemic antibiotic,
    antifungal, or antiviral treatment.
    13. Participants with diagnosis of chronic liver disease
    14. Participants with known active hepatitis A, HBV, or HCV infection or who are HIV-positive.
    15. Unwillingness to be transfused with blood components including RBC packs and platelet
    transfusions.
    16. Any condition in the investigator's judgment that would interfere with full participation in
    the study.
    17. Active alcohol or drug addiction that would interfere with their ability to comply with the
    study requirements.
    18. Gastroesophageal reflux disease not controlled by medication within 28 days before the first dose of study treatment.
    19. Has any unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic
    toxicities (≤ Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy.
    20. Known hypersensitivity, severe reaction, or any known contraindications to the use of
    any of the active substances or excipients in INCB000928 or ruxolitinib as appropriate to
    the relevant treatment group.
    21. Women who are pregnant or breastfeeding.
    22. Unable to swallow and retain oral medication.
    23. Current use of prohibited medication
    24. Participants with laboratory values at screening as defined.
    25. Participants undergoing treatment with ESAs, G-CSF or GM-CSF, romiplostin, or
    eltrombopag at any time within 4 weeks before the first dose of study treatment.
    E.5 End points
    E.5.1Primary end point(s)
    • Frequency and severity of AEs and SAEs, including changes in vital signs, ECGs, physical examinations, and clinical blood and urine laboratory parameters.
    • Identification of the DLTs, MTD, and RDE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety and endpoint assessments will be performed throughout the study.
    E.5.2Secondary end point(s)
    • Anemia response, defined as follows:
    − An Hgb increase of 1.5 g/dL relative to baseline for any "rolling" 12-week period (84 days with each assessment meeting this requirement) during the first 24 weeks of treatment if TI at baseline
    OR
    − Achieving TI for any "rolling" 12-week period (absence of any RBC transfusion over any 84-day period) during the first 24 weeks of treatment if TD at baseline.
    • Duration of anemia response, defined as follows:
    − The interval from the first onset of anemia response to the earliest date of loss of anemia
    response that persists for at least 4 weeks or death from any cause (for the TI participants at baseline)
    OR
    − Duration of RBC-TI period for participants achieving RBC-TI for at least 12 consecutive weeks during the first 24 weeks of treatment (for the TD participants at baseline).
    • Mean change from baseline in the Hgb value over 12-week treatment periods.
    • Rate of RBC transfusion through Weeks 24 and 48, defined as the average number of RBC units per participant-month during the treatment period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoint assessments will be performed throughout the study.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1/2 study in patients with myelofibrosis
    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 Yes
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    France
    Italy
    United States
    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
    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 months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days1
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 100
    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 Decision2020-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-08
    P. End of Trial
    P.End of Trial StatusOngoing
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