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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04281108
Registration number
NCT04281108
Ethics application status
Date submitted
20/02/2020
Date registered
24/02/2020
Date last updated
12/06/2023
Titles & IDs
Public title
Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)
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Scientific title
Fluticasone Propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 With an Open-label Extension, in Adult Subjects With Eosinophilic Esophagitis
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Secondary ID [1]
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SP-1011-003
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Universal Trial Number (UTN)
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Trial acronym
FLUTE-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Esophagitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Inflammatory and Immune System
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - APT-1011
Treatment: Drugs - Placebo oral tablet
Treatment: Surgery - Esophagogastroduodenoscopy
Experimental: APT-1011 - APT-1011 3 mg HS
Placebo Comparator: Placebo - HS
Treatment: Drugs: APT-1011
APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
Treatment: Drugs: Placebo oral tablet
Placebo orally disintegrating tablet.
Treatment: Surgery: Esophagogastroduodenoscopy
Esophagogastroduodenoscopy (EGD) is a test that involves an endoscope, a lighted camera on the end of a tube, that is passed down a subject's throat to visualize their esophagus.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Week 12 histologic responder rates
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Assessment method [1]
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To compare the Week 12 histologic responder rates (= 6 peak eosinophils [eos]/high power field [HPF]) for APT-1011 3 mg HS with that for placebo. HPF will be defined as a standard area of 235 square microns in a microscope with 40x lens (0.3 mm^2) and 22 mm ocular
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Timepoint [1]
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Week 12
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Primary outcome [2]
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Mean change in number of dysphagia episodes
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Assessment method [2]
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To compare the mean change in number of dysphagia episodes from baseline to Week 12 for APT-1011 3 mg HS with that for placebo
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Timepoint [2]
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Week 0 to Week 12
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Primary outcome [3]
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Histologic responder rates at the end of the Randomized Withdrawal Phase (RWS)
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Assessment method [3]
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To compare the histologic responder rates (= 6 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) at the end of the RWS
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Timepoint [3]
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Week 12 to Week 52
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Primary outcome [4]
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Percentage subjects with complete symptomatic response at the end of the RWS
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Assessment method [4]
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Percentage of subjects with complete symptomatic response (i.e., no dysphagia episodes for the 14 consecutive days prior to the end of the randomized withdrawal phase) at the end of the randomized withdrawal phase, in the RWS APT-1011 3 mg HS arm versus placebo arm
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Timepoint [4]
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Week 0 to Week 52
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Secondary outcome [1]
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Change in EREFs from Week 0 to Week 12
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Assessment method [1]
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To compare endoscopic appearance evaluated by the mean change from baseline to Week 12 in Eosinophilic Esophagitis Endoscopic Reference Score (EREFs) for APT-1011 3 mg HS with that for placebo.
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Timepoint [1]
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Week 0 to Week 12
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Secondary outcome [2]
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Percentage of subjects with <1 peak eos/HPF at Week 12
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Assessment method [2]
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To compare the percentage of subjects with <1 peak eos/HPF at Week 12 for APT-1011 3 mg HS with that for placebo.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Mean change in PROSE Symptom Burden Score
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Assessment method [3]
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To compare the mean change from baseline to Week 12 in the day-level symptom burden utilizing the Patient Reported Outcomes Symptoms of EoE (PROSE) for APT-1011 3 mg HS with that for placebo.
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Timepoint [3]
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Week 0 to Week 12
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Secondary outcome [4]
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Mean Change in PROSE Day-Level Difficulty Swallowing
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Assessment method [4]
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To compare the mean change from baseline to Week 12 in day-level difficulty swallowing using the Patient Reported Outcomes Symptoms of EoE (PROSE) for APT-1011 3 mg HS with that for placebo. Each symptom is rated on a numeric rating scale (NRS) with values ranging from 0 (not at all) to 10 (as bad as I can imagine).
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Timepoint [4]
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Week 0 to Week 12
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Secondary outcome [5]
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Mean Histologic Change from Baseline to Week 12
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Assessment method [5]
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To compare mean histologic change from baseline to Week 12 for APT-1011 3 mg HS with that for placebo.
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Timepoint [5]
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Week 0 to Week 12
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Secondary outcome [6]
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Percentage of Subjects with <15 peak eos/HPF
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Assessment method [6]
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To compare the percentage of subjects with <15 peak eos/HPF for APT-1011 3 mg HS with that for placebo.
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Mean Number of Dysphagia-free Days
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Assessment method [7]
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To compare the mean number of dysphagia-free days from baseline to Week 12 for APT-1011 3 mg HS with that for placebo
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Timepoint [7]
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Week 0 to Week 12
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Secondary outcome [8]
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Mean Change in Dysphagia Episodes
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Assessment method [8]
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To compare mean change in number of dysphagia episodes from baseline to the end of RWS for APT-1011 responders randomized to continue APT-1011 3 mg HS with responders randomized to placebo (withdrawal of APT-1011 3 mg HS)
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Timepoint [8]
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Week 0 to Week 52
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Secondary outcome [9]
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Mean Change in EREFs from Week 0 to Week 52
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Assessment method [9]
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To compare endoscopic appearance evaluated by the mean change from baseline to the end of RWS, in Eosinophilic Esophagitis Endoscopic Reference Score (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). The EREF score has a range from 0-9, with 9 being worst result.
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Timepoint [9]
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Week 0 to Week 52
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Secondary outcome [10]
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Mean Histologic Change
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Assessment method [10]
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To compare the mean change from baseline to the end of the RWS in peak eosinophil counts for APT-1011 responders randomized to APT-1011 3 mg HS with those randomized to placebo in the RWS.
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Timepoint [10]
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Week 0 to Week 52
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Secondary outcome [11]
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Mean Change in PROSE Day-Level Symptom Burden
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Assessment method [11]
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To compare the mean change in day-level symptom burden using the Patient Reported Outcomes Symptoms of EoE (PROSE) from baseline to the end of RWS, for APT-1011 responders randomized to continue APT-1011 3 mg HS with responders randomized to placebo (withdrawal of APT-1011 3 mg HS). Day-level symptom burden has values ranging from 0 (no symptoms) to 10 (symptoms are as bad as I can imagine).
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Timepoint [11]
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Week 0 to Week 52
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Secondary outcome [12]
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Mean Change in PROSE Day-Level Difficulty Swallowing
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Assessment method [12]
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To compare the mean change in day-level difficulty swallowing using the Patient Reported Outcomes Symptoms of EoE (PROSE) from baseline to the end of randomized withdrawal phase, for APT-1011 responders randomized to continue APT-1011 3 mg HS with responders randomized to placebo (withdrawal of APT-1011 3 mg HS). Each symptom is rated on a numeric rating scale (NRS) with values ranging from 0 (not at all) to 10 (as bad as I can imagine).
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Timepoint [12]
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Week 0 to Week 52
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Secondary outcome [13]
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Mean Change in Dysphagia-Free Days
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Assessment method [13]
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To compare the mean number of dysphagia-free days from baseline to the end of RWS, for APT-1011 responders randomized to continue APT-1011 3 mg HS with responders randomized to placebo (withdrawal of APT-1011 3 mg HS)
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Timepoint [13]
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Week 0 to Week 52
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Secondary outcome [14]
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Mean Change in Number of Dysphagia Episodes
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Assessment method [14]
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To compare mean change in number of dysphagia episodes from baseline at or prior to Week 52 (based on timing of > 6 peak eos/HPF) for APT-1011 responders randomized to continue APT-1011 3 mg HS with those randomized to placebo (withdrawal of APT-1011 3 mg HS)
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Timepoint [14]
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Week 0 to Week 52
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Eligibility
Key inclusion criteria
1. Male or female =18 years of age at the time of informed consent or assent
2. Each subject must read, understand, and provide consent 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 including 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 (0.3 mm^2) and 22 mm ocular.
1. Esophagogastroduodenoscopies and biopsies are to be obtained during the Screening
period
2. Biopsies will be read by a central pathologist
3. Esophagogastroduodenoscopies and biopsies performed outside the study will not be
accepted to meet eligibility criteria
4. Optional biopsies may be taken and processed locally for local use, if 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 12 weeks prior
to Screening
4. 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
5. History or presence of oral or esophageal mucosal infection whilst using inhaled or
nasal corticosteroids
6. Have any mouth or dental condition that prevents normal eating (excluding braces)
7. 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)
8. Use of systemic (oral or parenteral) corticosteroids within 60 days before Screening,
use of swallowed corticosteroids within 30 days before Screening
9. Initiation of either inhaled or nasal corticosteroids or high-potency dermal topical
corticosteroids within 30 days before Screening
10. Use of calcineurin inhibitors or purine analogues (azathioprine, 6-mercaptopurine) in
the 12 weeks before Screening
11. Use of potent cytochrome P450 (CYP) 3A4 inhibitors (eg, ritonavir and ketoconazole) in
the 12 weeks before Screening
12. Initiation of an elimination diet or elemental diet within 30 days before Screening
(diet must remain stable after signing ICF)
13. 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 adrenocorticotropic hormone (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 (i.e., an abnormal result on the
ACTH stimulation test)
14. 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)
15. Subjects who have initiated, discontinued, or changed dosage regimen of histamine H2
receptor antagonists, antacids or antihistamines for any condition such as
gastro-esophageal reflux disease within 4 weeks before qualifying endoscopy during
Screening. If already receiving these drugs, the dosage must remain constant
throughout the study
16. 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
17. Infection with hepatitis B, hepatitis C, or human immunodeficiency virus
18. Have gastrointestinal bleeding or documented active peptic ulcer within 4 weeks prior
to Screening or entering a new study period
19. 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, or travel to, high endemic areas should be
assessed locally for tuberculosis before consideration for the study
20. Immunosuppression or immunodeficiency disorder
21. Have a history or presence of Crohn's disease, celiac disease, or other inflammatory
disease of the gastrointestinal tract, including eosinophilic gastroenteritis
22. Have current drug abuse in the opinion of the Investigator.
23. Have current alcohol abuse in the opinion of the Investigator.
24. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during
the study
25. Sexually active females of childbearing potential who do not agree to follow highly
effective contraceptive methods through the End of Study visit
26. 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
27. Have participated in a prior study with investigational product APT-1011
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/01/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/10/2022
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Sample size
Target
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Accrual to date
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Final
143
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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St. Vincent's Hospital Sydney - Darlinghurst
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Recruitment hospital [2]
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Swallow Clinic, St George Hospital - Kogarah
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Recruitment hospital [3]
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John Hunter Hospital - New Lambton
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Recruitment hospital [4]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [5]
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St. Vincent's Hospital - Fitzroy
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Recruitment hospital [6]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2305 - New Lambton
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Recruitment postcode(s) [4]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [5]
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3065 - Fitzroy
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Recruitment postcode(s) [6]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Iowa
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Maryland
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Michigan
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Minnesota
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Missouri
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Montana
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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South Dakota
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Texas
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Utah
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Virginia
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Spain
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Ciudad Real
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Spain
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State/province [25]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Ellodi Pharmaceuticals, LP
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a 2-part randomized, double-blind, placebo-controlled study followed by an open-label
extension (OLE) of APT-1011 in adults with EoE.
Part A will evaluate the efficacy and safety of APT-1011 3 mg administered hora somni (HS; at
bedtime) for the induction of response to treatment (histologic and symptomatic) over 12
weeks.
Part B will evaluate histological relapse-free status in patients re-randomized to continue
APT-1011 or placebo (active treatment withdrawal) until Week 52.
Part C, the OLE, will continue until regulatory approval of APT-1011 or Sponsor termination
of the study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04281108
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Evan Dellon, MD, MPH
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Address
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UNC Center for Eosphageal Diseases and Swallowing
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04281108
Download to PDF