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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/NCT05083312
Registration number
NCT05083312
Ethics application status
Date submitted
6/10/2021
Date registered
19/10/2021
Date last updated
21/09/2023
Titles & IDs
Public title
Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial
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Scientific title
An Adolescent Sub-study Within FLUTE-2: A Randomized, Double-blind, Placebo-Controlled Study of APT-1011 (Fluticasone Propionate Oral Dispersible Tablet Formulation), With an Open-label Extension, in Adolescent Subjects With Eosinophilic Esophagitis
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Secondary ID [1]
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SP-1011-003a
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Universal Trial Number (UTN)
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Trial acronym
FLUTEEN
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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
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
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Intervention code [1]
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Treatment: Drugs
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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 / high power field [eos/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 [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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Secondary outcome [1]
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Mean 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. The EREF score has a range from 0-9, with 9 being worst result.
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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 using 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 PROSE for APT-1011 3 mg HS with that for placebo
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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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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 at Week 12 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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Eligibility
Key inclusion criteria
1. Male or female =12 and <18 years of age
2. Each subject and their parents or legal guardian, must read, understand and provide
consent or assent 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 [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, 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
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Minimum age
12
Years
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Maximum age
17
Years
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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 at screening
3. Have history of an esophageal stricture requiring dilatation within the 12 weeks prior
to Screening
4. Bone mineral density >2 SD below height-adjusted for age
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 (persistent) or current oral or esophageal mucosal infection due
to inhaled or nasal corticosteroids
7. Have any mouth or dental condition that prevents normal eating (excluding braces)
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 CYP 3A4 inhibitors (e.g., 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 (i.e., an abnormal result on the ACTH stimulation test)
15. Use of biologic immunomodulators in the 24 weeks before Screening (environmental
allergen desensitization injection or oral therapy (excluding food allergen
desensitization) 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 during Screening. 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, or travel to, 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 gastroenteritis
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
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
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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
Parallel
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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
30/09/2021
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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
5/09/2022
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Sample size
Target
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Accrual to date
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Final
6
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Children's Hospital - Melbourne
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Recruitment postcode(s) [1]
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3052 - 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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Indiana
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Country [2]
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United States of America
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State/province [2]
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Massachusetts
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a randomized, double-blind, placebo-controlled study of APT-1011, followed by an
open-label extension (OLE) in adolescents (=12 to <18 years) with EoE.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05083312
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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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Mirna Chehade, MD, MPH
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Address
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Mount Sinai Center for Eosinophilic Disorders
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05083312
Download to PDF