Eosinophilic EsophagitisPhase 3FLUTEENNCT05083312
Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial
A Phase 3 study testing APT-1011 in people with Eosinophilic Esophagitis, run by Ellodi Pharmaceuticals, LP at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- APT-1011
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Sep 2021to 5 Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female ≥12 and <18 years of age
- 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
- 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.
- Esophagogastroduodenoscopies and biopsies are to be obtained during the Screening period
- Biopsies will be read by a central pathologist
- Esophagogastroduodenoscopies and biopsies performed outside the study will not be accepted to meet eligibility criteria
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- 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
- Have a subject-reported history of ≥6 episodes of dysphagia in the 14 days prior to baseline
- Completion of the daily diary on at least 11 out of the 14 days during the 2-week Baseline Symptom Assessment
Who cannot join
- Have known contraindication, hypersensitivity, or intolerance to corticosteroids
- 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
- Have history of an esophageal stricture requiring dilatation within the 12 weeks prior to Screening
- Bone mineral density >2 SD below height-adjusted for age
- 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)
- History of recurrent (persistent) or current oral or esophageal mucosal infection due to inhaled or nasal corticosteroids
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- Have any mouth or dental condition that prevents normal eating (excluding braces)
- 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)
- Use of systemic (oral or parenteral) corticosteroids within 60 days before Screening, use of swallowed corticosteroids within 30 days before Screening
- Initiation of either inhaled or nasal corticosteroids or high-potency dermal topical corticosteroids within 30 days before Screening
- Use of calcineurin inhibitors or purine analogues (azathioprine, 6-mercaptopurine) in the 12 weeks before Screening
- Use of potent CYP 3A4 inhibitors (e.g., ritonavir and ketoconazole) in the 12 weeks before Screening
- Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF)
- 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)
- 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)
- 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
- 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
- Infection with hepatitis B, hepatitis C, or human immunodeficiency virus
- Have gastrointestinal bleeding or documented active peptic ulcer within 4 weeks prior to Screening or entering a new study period
- 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
- Immunosuppression or immunodeficiency disorder
- Current malignancy or malignancy within 3 years of Screening. Subjects in remission for at least 3 years post-treatment may be enrolled.
- Known severe bleeding disorder
- Have a history or presence of Crohn's disease, celiac disease, or other inflammatory disease of the gastrointestinal tract, including eosinophilic gastroenteritis
- Have current drug abuse in the opinion of the Investigator.
- Have current alcohol abuse in the opinion of the Investigator.
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study
- Sexually active females of childbearing potential who do not agree to follow highly effective contraceptive methods through the End of Study visit
- 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
- Have participated in a prior study with investigational product APT-1011
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Boston Specialists
Boston, Massachusetts, 02111
IU School of Medicine Department of Pediatrics
Indianapolis, Indiana, 46202
About this study
Official 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
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.
Read the detailed description
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 that will evaluate the efficacy and safety of APT-1011 3 mg administered HS for the induction of response to treatment (histologic and symptomatic) over 12 weeks.
At Week 12, subjects may move into the open-label single arm study of APT-1011 3 mg hora somni (HS; at bedtime). All subjects who do not move into the open-label study will return at Week 14 for a 2-week off-treatment follow-up.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- APT-1011, Placebo oral tablet
- Keywords
- APT-1011, Esophagitis, Eosinophilic Esophagitis, Esophageal Diseases, Gastrointestinal Diseases, Gastroenteritis, Eosinophilia, Leukocyte Disorders, Hematologic Diseases, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases, Fluticasone, Anti-Inflammatory Agents, Bronchodilator Agents, Autonomic Agents, Peripheral Nervous System Agents, Anti-Asthmatic Agents, Respiratory System Agents, Anti-Allergic Agents
- Medical subject headings
- Eosinophilic Esophagitis, Esophagitis, Esophageal Diseases, Gastrointestinal Diseases, Gastroenteritis, Eosinophilia, Leukocyte Disorders, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APT-1011Drug
Also called fluticasone propionate
APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
Placebo oral tabletDrug
Also called PBO
Placebo orally disintegrating tablet
| Study group | Role | What they receive |
|---|---|---|
| APT-1011 | Experimental | APT-1011 3 mg HS Receives: Drug: APT-1011 |
| Placebo | Placebo comparator | HS Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Week 12 histologic responder rates
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
Measured: Week 12
Mean change in number of dysphagia episodes
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
Measured: Week 0 to Week 12
Secondary outcomes (7)
Mean change in EREFs from Week 0 to Week 12
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.
Measured: Week 0 to Week 12
Percentage of subjects with <1 peak eos/HPF at Week 12
To compare the percentage of subjects with <1 peak eos/HPF at Week 12 for APT-1011 3 mg HS with that for placebo
Measured: Week 12
Mean change in PROSE Symptom Burden Score
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
Measured: Week 0 to Week 12
Mean change in PROSE day-level difficulty swallowing
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
Measured: Week 0 to Week 12
Histologic Change from Baseline to Week 12
To compare mean histologic change from baseline to Week 12 for APT-1011 3 mg HS with that for placebo
Measured: Week 0 to Week 12
Percentage of subjects with <15 peak eos/HPF
To compare the percentage of subjects with <15 peak eos/HPF at Week 12 for APT-1011 3 mg HS with that for placebo
Measured: Week 12
Mean number of dysphagia-free days
To compare the mean number of dysphagia-free days from baseline to Week 12 for APT-1011 3 mg HS with that for placebo
Measured: Week 0 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start30 Sep 2021
- Primary completion5 Sep 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellodi Pharmaceuticals, LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mirna Chehade, MD, MPH, Principal investigator, Mount Sinai Center for Eosinophilic Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083312
- Sponsor's protocol ID
- SP-1011-003a
- Acronym
- FLUTEEN
- Status last verified
- Sep 2023
- First submitted
- 6 Oct 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05083312
- Acronym / sponsor ID
- FLUTEEN / SP-1011-003a
- Conditions
- Eosinophilic Esophagitis
- Keywords
- APT-1011, Esophagitis, Eosinophilic Esophagitis, Esophageal Diseases, Gastrointestinal Diseases, Gastroenteritis, Eosinophilia, Leukocyte Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ellodi Pharmaceuticals, LPIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 that will evaluate the efficacy and safety of APT-1011 3 mg administered HS for the induction of response to treatment (histologic and symptomatic) over 12 weeks.
At Week 12, subjects may move into the open-label single arm study of APT-1011 3 mg hora somni (HS; at bedtime). All subjects who do not move into the open-label study will return at Week 14 for a 2-week off-treatment follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APT-1011 | Experimental | Drug: APT-1011APT-1011 3 mg HS |
| Placebo | Placebo comparator | Drug: Placebo oral tabletHS |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Male or female ≥12 and <18 years of age
- 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
- 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.
- Have a subject-reported history of ≥6 episodes of dysphagia in the 14 days prior to baseline
- Completion of the daily diary on at least 11 out of the 14 days during the 2-week Baseline Symptom Assessment
Key exclusion criteria (30 listed)
- Have known contraindication, hypersensitivity, or intolerance to corticosteroids
- 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
- Have history of an esophageal stricture requiring dilatation within the 12 weeks prior to Screening
- Bone mineral density >2 SD below height-adjusted for age
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APT-1011Also: fluticasone propionateAPT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient. | Drug | APT-1011 |
| Placebo oral tabletAlso: PBOPlacebo orally disintegrating tablet | Drug | Placebo |
Primary outcome
Week 12 histologic responder rates
Time frame: Week 12
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
Mean change in number of dysphagia episodes
Time frame: Week 0 to Week 12
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
7 secondary outcomes
Mean change in EREFs from Week 0 to Week 12
Time frame: Week 0 to Week 12
Percentage of subjects with <1 peak eos/HPF at Week 12
Time frame: Week 12
Mean change in PROSE Symptom Burden Score
Time frame: Week 0 to Week 12
Mean change in PROSE day-level difficulty swallowing
Time frame: Week 0 to Week 12
Histologic Change from Baseline to Week 12
Time frame: Week 0 to Week 12
Percentage of subjects with <15 peak eos/HPF
Time frame: Week 12
Mean number of dysphagia-free days
Time frame: Week 0 to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirna Chehade, MD, MPH principal investigator
Mount Sinai Center for Eosinophilic Disorders
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing APT-1011 in people with Eosinophilic Esophagitis, run by Ellodi Pharmaceuticals, LP at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Week 12 histologic responder rates (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.