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24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3)

Primary Purpose

Eosinophilic Esophagitis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
APT-1011
Placebo oral tablet
Esophagogastroduodenoscopy
Sponsored by
Ellodi Pharmaceuticals, LP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring APT-1011, Esophagitis, Eosinophilic Esophagitis, Esophageal Diseases, Gastrointestinal Diseases, Digestive System 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, FLUTE 3, FLUTE III, Flute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult male or female ≥18 years of age at the time of informed consent 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 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 in total from both proximal and distal esophageal mucosal areas (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 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 to a maximum of 30 episodes of dysphagia in a 14-consecutive-day period within 18 days prior to baseline Completion of the evening eDiary on at least 11 out of the 14-consecutive-day observation period during the 4-week run-in period (Baseline Symptom Assessment).The minimum requirement of 11 days need not be consecutive. Exclusion Criteria: 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 (8-10 mm) endoscope Have history of an esophageal stricture requiring dilatation within the 12 weeks prior to Screening 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 History of recurrent or current oral or esophageal mucosal infection due to inhaled or nasal corticosteroids 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 30 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 cytochrome P450 (CYP) 3A4 inhibitors (e.g., ritonavir and ketoconazole) in the 4 weeks before Screening Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF) Abnormal 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 Use of biologic immunomodulators, including dupilumab for EoE, with dose last administered within 6 months before Screening (allergy desensitization injection or oral therapies 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 initiated PPIs within 8 weeks before qualifying endoscopy. If already receiving PPIs, the dosage regimen must remain constant throughout the study 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, with the exception of skin cancers other than melanoma. Subjects in remission for at least 3 years post-treatment may be enrolled. Have a history or presence of Crohn's disease, celiac disease, or other inflammatory disease of the gastrointestinal tract, including non-EoE eosinophilic gastrointestinal disorders (EGIDs) 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

Sites / Locations

  • Digestive Health SpecialistsRecruiting
  • East View Medical Research LLCRecruiting
  • Premier Allergy Asthma and ImmunologyRecruiting
  • Del Sol Research Management, LLC.Recruiting
  • Preferred Research Partners, Inc.Recruiting
  • Arkansas GastroenterologyRecruiting
  • Om Research LLCRecruiting
  • Providence Facey Medical FoundationRecruiting
  • United Medical DoctorsRecruiting
  • TriWest Research Associates, LLCRecruiting
  • Peak Gastroenterology AssociatesRecruiting
  • Western States Clinical Research, Inc.Recruiting
  • Medical Research Center of Connecticut, LLCRecruiting
  • Endoscopic Research IncRecruiting
  • Revival Clinical ResearchRecruiting
  • Summit Clinical Research, LLCRecruiting
  • GI Alliance - GlenviewRecruiting
  • GI Alliance - GurneeRecruiting
  • Gastroenterology Health Partners, PLLCRecruiting
  • University of Iowa Hospitals & ClinicsRecruiting
  • MGG Group Co., Inc., Chevy Chase Clinical ResearchRecruiting
  • Gastro Center of Maryland, LLCRecruiting
  • Velocity Clinical Research, Inc.Recruiting
  • Boston SpecialistsRecruiting
  • Clinical Research Institute of Michigan, LLCRecruiting
  • Clinical Research Institute of Michigan, LLCRecruiting
  • Gastroenterology Associates of Western MichiganRecruiting
  • MNGI Digestive Health, P.A.Recruiting
  • Clinical Research ProfessionalsRecruiting
  • Bozeman HealthRecruiting
  • Advanced Research InstituteRecruiting
  • New Mexico Clinical Research & Osteoporosis Center, Inc.Recruiting
  • Long Island Gastrointestinal Research Group LLPRecruiting
  • UNC Clinical and Translational Research Center (CTRC)Recruiting
  • Charlotte Gastroenterology & Hepatology, PLLCRecruiting
  • Carolina ResearchRecruiting
  • Bernstein Clinical ResearchRecruiting
  • Centricity Research ColumbusRecruiting
  • Northshore Gastroenterology Research, LLCRecruiting
  • Vital Prospects Clinical Research Institute., PCRecruiting
  • Perelman Center for Advanced MedicineRecruiting
  • Frontier Clinical Research, LLCRecruiting
  • Rapid City Medical Center, LLPRecruiting
  • Texas Digestive SpecialistsRecruiting
  • GI AllianceRecruiting
  • GI AllianceRecruiting
  • Southern Star Research Institute, LLC.Recruiting
  • GI AllianceRecruiting
  • Tranquil Clinical ResearchRecruiting
  • Advanced Research InstituteRecruiting
  • University of Utah HospitalRecruiting
  • Advanced Research InstituteRecruiting
  • Blue Ridge Medical ResearchRecruiting
  • Washington Gastroenterology, PLLC dba GI AllianceRecruiting
  • GI AllianceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

APT-1011

Placebo

Arm Description

APT-1011 3 mg HS

Placebo HS

Outcomes

Primary Outcome Measures

Histological Remission (Co-Primary Outcome Measure)
To evaluate the percentage of subjects with histological remission (defined ≤ 6 peak eosinophils [eos]/high power field [HPF] on esophageal mucosal biopsies at Week 24). 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
Complete Symptomatic Response (Co-Primary Outcome Measure)
To evaluate the percentage of subjects with complete symptomatic response at Week 24 (defined as zero dysphagia episodes in the 14 consecutive days prior to Week 24)

Secondary Outcome Measures

Clinicopathologic Responder Rate
To compare the percentage of clinicopathologic responders, defined as having complete symptomatic AND histological response at Week 24 (defined as zero dysphagia episodes in the 14 consecutive days prior to Week 24 AND ≤ 6 peak eos/HPF on esophageal mucosal biopsies)
Percentage of Subjects with ≥70% Reduction in Dysphagia Frequency
To evaluate the percentage of subjects with ≥70% reduction in dysphagia frequency at Week 24 as compared to baseline (as measured over the 14 consecutive days prior to each visit)
Mean Change in Dysphagia Frequency
To compare the mean change from baseline to Week 24 in dysphagia frequency (as measured over the 14 consecutive days prior to each visit)
Mean Change in PROSE Difficulty Swallowing
To compare the mean change from baseline to Week 24 in difficulty swallowing using the Patient Reported Outcomes Symptoms of Eosinophilic Esophagitis (PROSE)
Mean Change in PROSE Pain with Swallowing
To compare the mean change from baseline to Week 24 in pain with swallowing using the PROSE
Mean Number of Dysphagia-Free Days
To compare the mean number of dysphagia-free days from baseline to Week 24
Percentage of Responders (Strictures and ≥Grade 2 rings)
To compare the percentage of responders, defined as no longer having strictures and/or ≥Grade 2 rings which were present at baseline, at Week 24
Percentage of Responders (Strictures)
To compare the percentage of responders, defined as no longer having strictures which were present at baseline, at Week 24
Percentage of Responders (≥Grade 2 rings)
To compare the percentage of responders, defined as no longer having ≥Grade 2 rings which were present at baseline, at Week 24
Mean Change in EREFs
To compare endoscopic appearance evaluated by the mean change from baseline to Week 24 in Eosinophilic Esophagitis Endoscopic Reference Score (EREFs)
Time to First Complete Symptom Response
Time to first complete symptom response (defined as zero dysphagia episodes in a 14-consecutive-day period)

Full Information

First Posted
November 22, 2022
Last Updated
September 12, 2023
Sponsor
Ellodi Pharmaceuticals, LP
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1. Study Identification

Unique Protocol Identification Number
NCT05634746
Brief Title
24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3)
Official Title
Fluticasone Propionate Oral Disintegrating Tablet Formulation in Eosinophilic Esophagitis: A Randomized, Double-blind, Placebo-Controlled 24-Week Induction Study of APT-1011, Followed by a Single-arm Open-label Extension, in Adult Subjects With Eosinophilic Esophagitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ellodi Pharmaceuticals, LP

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 24-week randomized, double-blind, placebo-controlled induction study of APT-1011 in adults (≥18 years old) with eosinophilic esophagitis (EoE) followed by a single-arm, open-label extension. This study will evaluate the efficacy and safety of APT-1011 3 mg administered HS (hora somni, at bedtime) for the induction of response to treatment (symptomatic and histologic) over 24 weeks. The open-label extension will continue to evaluate long-term safety in subjects who consent to continue on open-label treatment with APT-1011.
Detailed Description
The efficacy and safety of APT-1011 3 mg administered at bedtime will be evaluated for the induction of response (histologic and symptomatic) after 24 weeks of treatment. After completing 24 weeks of double-blind study treatment, subjects may consent to participate in the open-label extension, otherwise they will complete study drug treatment and enter a 2-week off treatment safety follow-up. The duration of the double-blind portion of the study, screening through follow-up visit for subjects completing study drug at Week 24, will be up to 32 weeks long, i.e., 6-week screening period (the includes a 4-week run-in phase) followed by 24 weeks induction phase and 2 weeks off-treatment follow-up. For subjects consenting to participate in the open-label extension, the duration of the study will be determined by the Sponsor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
APT-1011, Esophagitis, Eosinophilic Esophagitis, Esophageal Diseases, Gastrointestinal Diseases, Digestive System 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, FLUTE 3, FLUTE III, Flute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
APT-1011
Arm Type
Experimental
Arm Description
APT-1011 3 mg HS
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo HS
Intervention Type
Drug
Intervention Name(s)
APT-1011
Intervention Description
APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient. Other Names: fluticasone propionate
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Placebo orally disintegrating tablet. Other Names: PBO
Intervention Type
Procedure
Intervention Name(s)
Esophagogastroduodenoscopy
Intervention Description
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
Primary Outcome Measure Information:
Title
Histological Remission (Co-Primary Outcome Measure)
Description
To evaluate the percentage of subjects with histological remission (defined ≤ 6 peak eosinophils [eos]/high power field [HPF] on esophageal mucosal biopsies at Week 24). 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
Time Frame
Week 24
Title
Complete Symptomatic Response (Co-Primary Outcome Measure)
Description
To evaluate the percentage of subjects with complete symptomatic response at Week 24 (defined as zero dysphagia episodes in the 14 consecutive days prior to Week 24)
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Clinicopathologic Responder Rate
Description
To compare the percentage of clinicopathologic responders, defined as having complete symptomatic AND histological response at Week 24 (defined as zero dysphagia episodes in the 14 consecutive days prior to Week 24 AND ≤ 6 peak eos/HPF on esophageal mucosal biopsies)
Time Frame
Week 24
Title
Percentage of Subjects with ≥70% Reduction in Dysphagia Frequency
Description
To evaluate the percentage of subjects with ≥70% reduction in dysphagia frequency at Week 24 as compared to baseline (as measured over the 14 consecutive days prior to each visit)
Time Frame
Week 24
Title
Mean Change in Dysphagia Frequency
Description
To compare the mean change from baseline to Week 24 in dysphagia frequency (as measured over the 14 consecutive days prior to each visit)
Time Frame
Week 24
Title
Mean Change in PROSE Difficulty Swallowing
Description
To compare the mean change from baseline to Week 24 in difficulty swallowing using the Patient Reported Outcomes Symptoms of Eosinophilic Esophagitis (PROSE)
Time Frame
Week 24
Title
Mean Change in PROSE Pain with Swallowing
Description
To compare the mean change from baseline to Week 24 in pain with swallowing using the PROSE
Time Frame
Week 24
Title
Mean Number of Dysphagia-Free Days
Description
To compare the mean number of dysphagia-free days from baseline to Week 24
Time Frame
Week 24
Title
Percentage of Responders (Strictures and ≥Grade 2 rings)
Description
To compare the percentage of responders, defined as no longer having strictures and/or ≥Grade 2 rings which were present at baseline, at Week 24
Time Frame
Week 24
Title
Percentage of Responders (Strictures)
Description
To compare the percentage of responders, defined as no longer having strictures which were present at baseline, at Week 24
Time Frame
Week 24
Title
Percentage of Responders (≥Grade 2 rings)
Description
To compare the percentage of responders, defined as no longer having ≥Grade 2 rings which were present at baseline, at Week 24
Time Frame
Week 24
Title
Mean Change in EREFs
Description
To compare endoscopic appearance evaluated by the mean change from baseline to Week 24 in Eosinophilic Esophagitis Endoscopic Reference Score (EREFs)
Time Frame
Week 24
Title
Time to First Complete Symptom Response
Description
Time to first complete symptom response (defined as zero dysphagia episodes in a 14-consecutive-day period)
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male or female ≥18 years of age at the time of informed consent 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 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 in total from both proximal and distal esophageal mucosal areas (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 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 to a maximum of 30 episodes of dysphagia in a 14-consecutive-day period within 18 days prior to baseline Completion of the evening eDiary on at least 11 out of the 14-consecutive-day observation period during the 4-week run-in period (Baseline Symptom Assessment).The minimum requirement of 11 days need not be consecutive. Exclusion Criteria: 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 (8-10 mm) endoscope Have history of an esophageal stricture requiring dilatation within the 12 weeks prior to Screening 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 History of recurrent or current oral or esophageal mucosal infection due to inhaled or nasal corticosteroids 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 30 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 cytochrome P450 (CYP) 3A4 inhibitors (e.g., ritonavir and ketoconazole) in the 4 weeks before Screening Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF) Abnormal 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 Use of biologic immunomodulators, including dupilumab for EoE, with dose last administered within 6 months before Screening (allergy desensitization injection or oral therapies 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 initiated PPIs within 8 weeks before qualifying endoscopy. If already receiving PPIs, the dosage regimen must remain constant throughout the study 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, with the exception of skin cancers other than melanoma. Subjects in remission for at least 3 years post-treatment may be enrolled. Have a history or presence of Crohn's disease, celiac disease, or other inflammatory disease of the gastrointestinal tract, including non-EoE eosinophilic gastrointestinal disorders (EGIDs) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karol Knoop, RN, BS, CCRA
Phone
1-833-435-8833
Email
ClinicalTrials@ellodipharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
David Strunk
Email
david.strunk@ellodipharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Dellon, MD, MPH
Organizational Affiliation
UNC Center for Esophageal Diseases and Swallowing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Digestive Health Specialists
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
East View Medical Research LLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Premier Allergy Asthma and Immunology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Del Sol Research Management, LLC.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Preferred Research Partners, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Om Research LLC
City
Camarillo
State/Province
California
ZIP/Postal Code
93012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Providence Facey Medical Foundation
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
United Medical Doctors
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
TriWest Research Associates, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Western States Clinical Research, Inc.
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Endoscopic Research Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Revival Clinical Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Summit Clinical Research, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
GI Alliance - Glenview
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
GI Alliance - Gurnee
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Gastroenterology Health Partners, PLLC
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
MGG Group Co., Inc., Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Gastro Center of Maryland, LLC
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Velocity Clinical Research, Inc.
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Boston Specialists
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Clinical Research Institute of Michigan, LLC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Gastroenterology Associates of Western Michigan
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
MNGI Digestive Health, P.A.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Bozeman Health
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Advanced Research Institute
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
New Mexico Clinical Research & Osteoporosis Center, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Long Island Gastrointestinal Research Group LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
UNC Clinical and Translational Research Center (CTRC)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Charlotte Gastroenterology & Hepatology, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Carolina Research
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Bernstein Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Centricity Research Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Northshore Gastroenterology Research, LLC
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Vital Prospects Clinical Research Institute., PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Frontier Clinical Research, LLC
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Rapid City Medical Center, LLP
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Texas Digestive Specialists
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
GI Alliance
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
GI Alliance
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Southern Star Research Institute, LLC.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
GI Alliance
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Tranquil Clinical Research
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Advanced Research Institute
City
Sandy
State/Province
Utah
ZIP/Postal Code
84092
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Blue Ridge Medical Research
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
Washington Gastroenterology, PLLC dba GI Alliance
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com
Facility Name
GI Alliance
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Knoop, RN, BS, CCRA
Phone
833-435-8833
Email
ClinicalTrials@ellodipharma.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3)

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