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    Summary
    EudraCT Number:2019-001521-27
    Sponsor's Protocol Code Number:SP-1011-003
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-02-10
    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 number2019-001521-27
    A.3Full title of the trial
    Fluticasone propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 in Adult and Adolescent Subjects with Eosinophilic Esophagitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study with Eosinophilic Esophagitis subjects
    A.3.2Name or abbreviated title of the trial where available
    FLUTE-2
    A.4.1Sponsor's protocol code numberSP-1011-003
    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 SponsorAdare Pharmaceuticals US, LP
    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 supportAdare Pharmaceuticals US, LP
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAdare Pharmaceuticals US, LP
    B.5.2Functional name of contact pointPeter C. Richardson
    B.5.3 Address:
    B.5.3.1Street AddressPrinceton Pike Corporate Center, 1200 Lenox Drive, Suite 100
    B.5.3.2Town/ cityLawrenceville, New Jersey
    B.5.3.3Post code08648
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1609450 1312
    B.5.5Fax number+1609896 1404
    B.5.6E-mailPeter.Richardson@adarepharma.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 numberEU/3/16/1815
    D.3 Description of the IMP
    D.3.1Product nameAPT-1011
    D.3.2Product code APT-1011 - 3 mg
    D.3.4Pharmaceutical form Orodispersible 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 INNFluticasone Propionate, USP
    D.3.9.1CAS number 80474-14-2
    D.3.9.2Current sponsor codeAPT-1011
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 placeboOrodispersible tablet
    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
    Eosinophilic Esophagitis
    E.1.1.1Medical condition in easily understood language
    Eosinophilic Esophagitis
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10064220
    E.1.2Term Eosinophilic esophagitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A co-primary objectives:
     To compare the Week 12 histologic responder rates (≤ 6 peak eosinophils [eos]/high power field [HPF]) for APT-1011 3 mg hora somni (HS) with that for placebo. HPF will be defined as a standard area of 235 square microns in a microscope with 40x lens and 22mm ocular
     To compare mean change in number of dysphagia episodes from baseline to Week 12 for APT-1011 3 mg HS with that for placebo

    Part B key objectives:
     To compare the Week 52 histologic relapse-free rates (≤ 15 peak eos/HPF) for APT-1011 responders randomized to continuing APT-1011 3 mg HS (maintenance) with responders randomized to placebo (withdrawal of APT-1011 3 mg HS)
     To compare mean change in number of dysphagia episodes from Week 12 at or prior Week 52 (based on timing of histologic relapse) for APT-1011 responders randomized to continue APT-1011 3 mg HS with responders randomized to placebo (withdrawal of APT-1011 3 mg HS)
    E.2.2Secondary objectives of the trial
    Part A secondary objectives
     To compare endoscopic appearance evaluated by the mean change from baseline to Week 12 in REFs for APT-1011 3 mg HS with that for placebo
     To compare the percentage of subjects with <1 peak eos/high power field at Week 12 for APT-1011 3 mg HS with that for placebo.

    Part B secondary objectives
     To compare endoscopic appearance evaluated by the mean change from Week 12 to the first esophagogastroduodenoscopy (EGD) conducted in Part B (at or prior to Week 52) in EREFs for APT-1011 responders randomized to continue APT-1011 3 mg HS with responders randomized to placebo (withdrawal of APT-1011 3 mg HS)
     To compare the mean histologic change from Week 12 to EGD conducted in Part B (at or prior to Week 52 ) for APT-1011 responders randomized to continue APT-1011 3 mg HS with responders randomized to placebo (withdrawal of APT-1011 3 mg HS)

    See the entire list in the protocol section Objectives in Page 4
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult male or female ≥12 years of age at the time of informed consent or assent
    2. Each subject and/or their parents or legal guardian (for adolescents), must read, understand and provide consent or assent together with their parent(s) or guardian signature (for adolescents) on the ICF for this study and be willing and able to adhere to study-related treatment regimens, procedures and visit schedule
    3. Diagnosis or presumptive diagnosis of EoE that is confirmed during the Screening period by histology that demonstrates ≥15 peak eos/HPF. In order to ensure that a diagnosis can be made, at least 6 biopsies should be taken from both proximal and distal specimens (at least 3 each). Mid-esophageal biopsies are not required (optional). HPF will be defined as a standard area of 235 square microns in a microscope with 40x lens and 22mm ocular.
    a) Esophagogastroduodenoscopies and biopsies are to be obtained during the Screening period
    b) Biopsies will be read by a central pathologist
    c) Esophagogastroduodenoscopies and biopsies performed outside the study will not be accepted to meet eligibility criteria
    d) Optional biopsies may be taken and processed locally for local use, only where specified in the local ICF. If serious pathology is unexpectedly encountered biopsies of such lesions must be processed locally
    4. Have a subject-reported history of ≥6 episodes of dysphagia in the 14 days prior to baseline
    5. Completion of the daily diary on at least 11 out of the 14 days during the 2-week Baseline Symptom Assessment
    E.4Principal exclusion criteria
    1. Have known contraindication, hypersensitivity, or intolerance to corticosteroids
    2. Have a contraindication to, or factors that substantially increase the risk of, EGD procedure or esophageal biopsy or have narrowing of the esophagus that precludes EGD with a standard 9 mm endoscope
    3. Have history of an esophageal stricture requiring dilatation within the previous 12 weeks prior to Screening
    4. Bone age more than 12 months behind chronological age for adolescent subjects
    5. Have any physical, mental, or social condition or history of illness or laboratory abnormality that in the Investigator’s judgment might interfere with study procedures or the ability of the subject to adhere to and complete the study or increase the safety risk to the subject such as uncontrolled diabetes or hypertension or may increase risk of corticosteroid toxicity (e.g. abnormal bone mineral density)
    6. History of recurrent or current oral or esophageal mucosal infection due to inhaled or nasal corticosteroids
    7. Have any mouth or dental condition that prevents normal eating
    8. Have any condition affecting the esophageal mucosa or altering esophageal motility other than EoE, including erosive esophagitis (grade B or higher as per the Los Angeles Classification of Gastroesophageal Reflux Disease; hiatus hernia longer than 3 cm, Barrett’s esophagus, and achalasia)
    9. Use of systemic (oral or parenteral) corticosteroids within 60 days before Screening, use of swallowed corticosteroids within 30 days before Screening
    10. Initiation of either inhaled or nasal corticosteroids or high-potency dermal topical corticosteroids within 30 days before Screening
    11. Use of calcineurin inhibitors or purine analogues (azathioprine, 6-mercaptopurine) in the 12 weeks before Screening
    12. Use of potent cytochrome P450 (CYP) 3A4 inhibitors (eg, ritonavir and ketoconazole) in the 12 weeks before Screening
    13. Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF)
    14. Morning (07:00 to 09:00, or as close to that window as possible) serum cortisol level ≤5 μg/dL (138 nmol/L) that is not responsive to ACTH stimulation: defined as a serum cortisol level <16 μg/dL (440 nmol/L) at 60 minutes with ACTH stimulation test using 250 μg cosyntropin administered intramuscularly (ie, an abnormal result on the ACTH stimulation test)
    15. Use of biologic immunomodulators in the 24 weeks before Screening (allergy desensitization injection or oral therapy is allowed as long as the course of therapy is not altered during the study period)
    16. Subjects who have initiated, discontinued, or changed dosage regimen of histamine H2 receptor antagonists, antacids or antihistamines, leukotriene inhibitors or sodium cromolyn within 4 weeks before qualifying endoscopy. If already receiving these drugs, the dosage must remain constant throughout the study
    17. Subjects who have changed dosage regimen of PPIs within 8 weeks before qualifying endoscopy. If already receiving PPIs, the dosage must remain constant throughout the study
    18. Infection with hepatitis B, hepatitis C, or human immunodeficiency virus
    19. Have gastrointestinal bleeding or documented active peptic ulcer within 4 weeks prior to Screening or entering a new study period
    20. Have chronic infection such as prior or active tuberculosis, active chicken pox or measles or absence of prior measles, mumps and rubella vaccine. Subjects with tuberculosis exposure or who live in high endemic areas should be assessed locally for tuberculosis before consideration for the study
    21. Immunosuppression or immunodeficiency disorder
    22. Current malignancy or malignancy within 3 years of Screening. Subjects in remission for at least 3 years post-treatment may be enrolled.
    23. Known severe bleeding disorder
    24. Have a history or presence of Crohn’s disease, celiac disease, or other inflammatory disease of the gastrointestinal tract, including eosinophilic gastroenteriti
    25. Have current drug abuse in the opinion of the Investigator.
    26. Have current alcohol abuse in the opinion of the Investigator.
    27. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study
    28. Sexually active females of childbearing potential who do not agree to follow highly effective contraceptive methods through the End of Study visit (see Section 9.6.4 and Appendix 1)
    29. Have received an investigational product, as part of a clinical trial within 30 days (or 5 half-lives, whichever is longest) of Screening. Subjects who are currently participating in observational studies or enrolled in patient registries are allowed in this study
    30. Have participated in a prior study with investigational product APT-1011
    E.5 End points
    E.5.1Primary end point(s)
    Part A co-primary endpoints:
     Percentage of subjects who are histological responders (achieve ≤6 peak eos/HPF) at Week 12
     Mean change from baseline to Week 12 in number of dysphagia episodes

    Part B key endpoints:
     Percentage of APT-1011 responders in Part A who relapse histologically (>15 peak eos/HPF) by Week 52
     Mean change from Week 12 in Part A responders in number of dysphagia episodes at time of EGD at or before Week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A co-primary endpoints:
     at Week 12
     from baseline to Week 12

    Part B key endpoints:
     by Week 52 in Part A
     from Week 12 in Part A and at or before Week 52
    E.5.2Secondary end point(s)
    Part A secondary endpoints:
     Mean change from baseline in mean EREFs at Week 12
     Percentage of subjects who achieve <1 eos/HPF at Week 12
     Mean change from baseline in mean day-level symptom burden (PROSE) at Week 12
     Mean change from baseline in mean day-level severity (PROSE) at Week 12
     Mean change from baseline in mean eosinophils per HPF at Week 12
     Percentage of subjects who achieve <15 eos/HPF at Week 12
     Mean change from baseline in mean number of dysphagia-free days at Week 12

    Part B secondary endpoints:
     Mean change from Week 12 in Part A responders in mean EREF scores at time of EGD at or before Week 52
     Mean change from Week 12 in Part A responders in mean eosinophils per high power field at time of EGD at or before Week 52
     Mean change from Week 12 in Part A responders in day-level symptom burden using the PROSE at time of EGD at or before Week 52
     Mean change from Week 12 in Part A responders in day-level severity using the PROSE at time of EGD at or before Week 52
     Mean change from Week 12 in Part A responders in mean number of dysphagia-free days at time of EGD at or before Week 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A secondary endpoints:
     from baseline at Week 12
     at Week 12
     from baseline at Week 12
     from baseline at Week 12
     from baseline at Week 12
     at Week 12
     from baseline at Week 12

    Part B secondary endpoints:
     from Week 12 in Part A or before Week 52
     from Week 12 in Part A or before Week 52
     from Week 12 in Part A or before Week 52
     from Week 12 in Part A or before Week 52
     from Week 12 in Part A or before Week 52
    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) No
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Australia
    Germany
    Spain
    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 years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days17
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 20
    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: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 120
    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)
    See protocol section treatment duration page 9
    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 Decision2020-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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