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Efficacy and Safety APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)

Study Purpose

This is a 2-part randomized, double-blind, placebo-controlled study of APT-1011 in adults and adolescents (≥12 years) with EoE. Part A 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. Part B will evaluate histological relapse-free status in patients re-randomized to continue APT-1011 or placebo (active treatment withdrawal) until Week 52.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female ≥12 years of age at the time of informed consent or assent. 2. Each subject and/or their parents or legal guardian (for adolescents), must read, understand and provide consent or assent together with their parent(s) or guardian signature (for adolescents) on the ICF for this study and be willing and able to adhere to study-related treatment regimens, procedures and visit schedule. 3. Diagnosis or presumptive diagnosis of EoE that is confirmed during the Screening period by histology that demonstrates ≥15 peak eos/HPF. In order to ensure that a diagnosis can be made, at least 5-6 biopsies should be taken including both proximal and distal specimens (~3 each). Mid-esophageal biopsies are optional. 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.

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. Bone age more than 12 months behind chronological age for adolescent subjects. 5. Have any physical, mental, or social condition or history of illness or laboratory abnormality that in the Investigator's judgment might interfere with study procedures or the ability of the subject to adhere to and complete the study or increase the safety risk to the subject such as uncontrolled diabetes or hypertension or may increase risk of corticosteroid toxicity (e.g. abnormal bone mineral density) 6. History or presence of oral or esophageal mucosal infection whilst using 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;19, hiatus hernia longer than 3 cm, Barrett's esophagus, and achalasia) 9. Use of systemic (oral or parenteral) corticosteroids within 60 days before Screening, use of swallowed corticosteroids within 30 days before Screening. 10. Initiation of either inhaled or nasal corticosteroids or high-potency dermal topical corticosteroids within 30 days before Screening. 11. Use of calcineurin inhibitors or purine analogues (azathioprine, 6-mercaptopurine) in the 12 weeks before Screening. 12. Use of potent cytochrome P450 (CYP) 3A4 inhibitors (eg, ritonavir and ketoconazole) in the 12 weeks before Screening. 13. Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF) 14. Morning (07:00 to 09:00, or as close to that window as possible) serum cortisol level ≤5 μg/dL (138 nmol/L) that is not responsive to ACTH stimulation: defined as a serum cortisol level <16 μg/dL (440 nmol/L) at 60 minutes with ACTH stimulation test using 250 μg cosyntropin (ie, an abnormal result on the ACTH stimulation test) 15. Use of biologic immunomodulators in the 24 weeks before Screening (allergy desensitization injection or oral therapy is allowed as long as the course of therapy is not altered during the study period) 16. Subjects who have initiated, discontinued, or changed dosage regimen of histamine H2 receptor antagonists, antacids or antihistamines 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. 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. Have immunosuppression, immunodeficiency, malignancy (except treated non-melanoma skin cancer), or known severe bleeding disorder. 22. Have a history or presence of Crohn's disease, celiac disease, or other inflammatory disease of the gastrointestinal tract, including eosinophilic gastroenteritis. 23. Have current drug abuse in the opinion of the Investigator. 24. Have current alcohol abuse in the opinion of the Investigator. 25. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study. 26. Sexually active females of childbearing potential who do not agree to follow highly effective contraceptive methods through the End of Study visit. 27. 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. 28. Have participated in a prior study with investigational product APT-1011

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04281108
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ellodi Pharmaceuticals, LP
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Evan Dellon, MD, MPH
Principal Investigator Affiliation UNC Center for Eosphageal Diseases and Swallowing
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Germany, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Additional Details

This is a 2-part randomized, double-blind, placebo-controlled study of APT-1011 in adults and adolescents (≥12 years) with EoE. Part A 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 14, subjects will move into Part B. Subjects with histological response to APT-1011, defined as ≤6 peak eos/HPF, will be re-randomized to continue APT-1011 or receive placebo (active treatment withdrawal). APT-1011 histological non-responders will continue APT-1011, placebo histological non-responders will receive APT-1011 3mg HS. Placebo histological responders will continue placebo. Histological responder status will be determined at the time of EGD in Part B (at or prior to Week 52, depending on unscheduled EGDs) and is defined as ≤6 peak eos/HPF.

Arms & Interventions

Arms

Experimental: APT-1011

APT-1011 3 mg HS

Placebo Comparator: Placebo

HS

Interventions

Drug: - APT-1011

APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.

Drug: - Placebo oral tablet

Placebo orally disintegrating tablet.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pinnacle Research Group, LLC, Anniston, Alabama

Status

Active, not recruiting

Address

Pinnacle Research Group, LLC

Anniston, Alabama, 36207

Dothan, Alabama

Status

Withdrawn

Address

Gut P.C., dba; Digestive Health Specialists of the Southeast

Dothan, Alabama, 36305

East View Medical Research, LLC, Mobile, Alabama

Status

Active, not recruiting

Address

East View Medical Research, LLC

Mobile, Alabama, 36606

Del Sol Research Management, LLC, Tucson, Arizona

Status

Active, not recruiting

Address

Del Sol Research Management, LLC

Tucson, Arizona, 85712

Preferred Research Partners Inc., Little Rock, Arkansas

Status

Active, not recruiting

Address

Preferred Research Partners Inc.

Little Rock, Arkansas, 72211

Arkansas Gastroenterology, North Little Rock, Arkansas

Status

Active, not recruiting

Address

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117

Camarillo Endoscopy Center, Camarillo, California

Status

Active, not recruiting

Address

Camarillo Endoscopy Center

Camarillo, California, 93012

Hope Clinical Research, Canoga Park, California

Status

Active, not recruiting

Address

Hope Clinical Research

Canoga Park, California, 91303

TriWest Research Associates, LLC, El Cajon, California

Status

Withdrawn

Address

TriWest Research Associates, LLC

El Cajon, California, 92020

Om Research LLC, Lancaster, California

Status

Withdrawn

Address

Om Research LLC

Lancaster, California, 93534

Facey Medical Foundation, Mission Hills, California

Status

Active, not recruiting

Address

Facey Medical Foundation

Mission Hills, California, 91345

United Medical Doctors, Murrieta, California

Status

Active, not recruiting

Address

United Medical Doctors

Murrieta, California, 92563

Children's Hospital of Orange County, Orange, California

Status

Active, not recruiting

Address

Children's Hospital of Orange County

Orange, California, 92868

Redwood City, California

Status

Withdrawn

Address

Stanford University Medical Center, Division of Gastroenterology and Hepatology

Redwood City, California, 94063

Inland Empire Clinical Trials, LLC, Rialto, California

Status

Withdrawn

Address

Inland Empire Clinical Trials, LLC

Rialto, California, 92377

Medical Associates Research Group, San Diego, California

Status

Active, not recruiting

Address

Medical Associates Research Group

San Diego, California, 92123

Great Lakes Medical Research LLC, San Diego, California

Status

Withdrawn

Address

Great Lakes Medical Research LLC

San Diego, California, 92130

Asthma and Allergy Associates, PC, Colorado Springs, Colorado

Status

Active, not recruiting

Address

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 80907

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Active, not recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

Denver, Colorado

Status

Not yet recruiting

Address

Rocky Mountain Pediatric Gastroenterology

Denver, Colorado, 80214

Site Contact

Karol Knoop, RN, BS, CCRA

karol.knoop@ellodipharma.com

609-450-1312

Western States Clinical Research Inc., Wheat Ridge, Colorado

Status

Active, not recruiting

Address

Western States Clinical Research Inc.

Wheat Ridge, Colorado, 80033

Danbury, Connecticut

Status

Active, not recruiting

Address

Western Connecticut Medical Group - Gastroenterology

Danbury, Connecticut, 06810

Hamden, Connecticut

Status

Active, not recruiting

Address

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518

Fleming Island, Florida

Status

Active, not recruiting

Address

Fleming Island Center for Clinical Research

Fleming Island, Florida, 32003

Universal Axon - Homestead, LLC, Homestead, Florida

Status

Withdrawn

Address

Universal Axon - Homestead, LLC

Homestead, Florida, 33030

Nature Coast Clinical Research, Inverness, Florida

Status

Active, not recruiting

Address

Nature Coast Clinical Research

Inverness, Florida, 34452

Encore Borland Groover Clinical Research, Jacksonville, Florida

Status

Active, not recruiting

Address

Encore Borland Groover Clinical Research

Jacksonville, Florida, 32256

Endoscopic Research, Inc., Orlando, Florida

Status

Active, not recruiting

Address

Endoscopic Research, Inc.

Orlando, Florida, 32803

DBC Research USA, Pembroke Pines, Florida

Status

Active, not recruiting

Address

DBC Research USA

Pembroke Pines, Florida, 33029

Summit Clinical Research, Athens, Georgia

Status

Active, not recruiting

Address

Summit Clinical Research

Athens, Georgia, 30607

Chicago, Illinois

Status

Withdrawn

Address

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611

Indianapolis, Indiana

Status

Not yet recruiting

Address

IU School of Medicine Department of Pediatrics

Indianapolis, Indiana, 46202

Site Contact

Karol Knoop, RN, BS, CCRA

karol.knoop@ellodipharma.com

609-450-1312

University of Iowa Hospitals and Clinics, Iowa City, Iowa

Status

Active, not recruiting

Address

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

Louisiana Research Center, LLC, Shreveport, Louisiana

Status

Withdrawn

Address

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105

Chevy Chase, Maryland

Status

Active, not recruiting

Address

MGG Group Co., Inc., Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815

Gastro Center of Maryland, Columbia, Maryland

Status

Active, not recruiting

Address

Gastro Center of Maryland

Columbia, Maryland, 21045

Tufts Medical Centre, Boston, Massachusetts

Status

Recruiting

Address

Tufts Medical Centre

Boston, Massachusetts, 02111

Site Contact

Karol Knoop, RN, BS, CCRA

karol.knoop@ellodipharma.com

609-450-1312

Ann Arbor, Michigan

Status

Active, not recruiting

Address

Michigan Medicine, University of Michigan

Ann Arbor, Michigan, 48109

Chesterfield, Michigan

Status

Active, not recruiting

Address

Clinical Research Institute of Michigan LLC

Chesterfield, Michigan, 48047

Henry Ford Health System, Novi, Michigan

Status

Active, not recruiting

Address

Henry Ford Health System

Novi, Michigan, 48377

West Michigan Clinical Research Center, Wyoming, Michigan

Status

Active, not recruiting

Address

West Michigan Clinical Research Center

Wyoming, Michigan, 49519

Minnesota Gastroenterology, P.A., Plymouth, Minnesota

Status

Active, not recruiting

Address

Minnesota Gastroenterology, P.A.

Plymouth, Minnesota, 55446

Mayo Clinic, Rochester, Minnesota

Status

Active, not recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Clinical Research Professionals, Chesterfield, Missouri

Status

Active, not recruiting

Address

Clinical Research Professionals

Chesterfield, Missouri, 63005

Bozeman Health GI Clinic, Bozeman, Montana

Status

Active, not recruiting

Address

Bozeman Health GI Clinic

Bozeman, Montana, 59715

Lincoln, Nebraska

Status

Withdrawn

Address

Allergy, Asthma & Immunology Associates, PC

Lincoln, Nebraska, 68505

Great Neck, New York

Status

Active, not recruiting

Address

Long Island Gastrointestinal Research Group LLP

Great Neck, New York, 11023

Weill Cornell Medical College, New York, New York

Status

Withdrawn

Address

Weill Cornell Medical College

New York, New York, 10021

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Not yet recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

Karol Knoop, RN, BS, CCRA

karol.knoop@ellodipharma.com

609-450-1312

Chapel Hill, North Carolina

Status

Active, not recruiting

Address

University of North Carolina Health Systems (UNC Hospital)

Chapel Hill, North Carolina, 27599

Charlotte Gastroenterology & Hepatology, Charlotte, North Carolina

Status

Withdrawn

Address

Charlotte Gastroenterology & Hepatology

Charlotte, North Carolina, 28207

Clinical Research of Charlotte, Charlotte, North Carolina

Status

Withdrawn

Address

Clinical Research of Charlotte

Charlotte, North Carolina, 28277

Carolina Research, Greenville, North Carolina

Status

Active, not recruiting

Address

Carolina Research

Greenville, North Carolina, 27834

M3 Wake Research, Inc, Raleigh, North Carolina

Status

Withdrawn

Address

M3 Wake Research, Inc

Raleigh, North Carolina, 27612

Beachwood, Ohio

Status

Active, not recruiting

Address

Gastroenterology Associates of Cleveland, Inc.

Beachwood, Ohio, 44122

Consultants for Clinical Research, Cincinnati, Ohio

Status

Active, not recruiting

Address

Consultants for Clinical Research

Cincinnati, Ohio, 45219

Bernstein Clinical Research Center, LLC, Cincinnati, Ohio

Status

Active, not recruiting

Address

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45231

Mentor, Ohio

Status

Active, not recruiting

Address

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060

Westlake, Ohio

Status

Active, not recruiting

Address

Northshore Gastroenterology Research, LLC

Westlake, Ohio, 44145

Tulsa, Oklahoma

Status

Active, not recruiting

Address

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, 74136

Medford, Oregon

Status

Withdrawn

Address

Crisor LLC, c/o Clinical Research Institute of Southern Oregon PC

Medford, Oregon, 97504

Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania

Status

Active, not recruiting

Address

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104

Digestive Disease Associates LTD, Wyomissing, Pennsylvania

Status

Active, not recruiting

Address

Digestive Disease Associates LTD

Wyomissing, Pennsylvania, 19610

Rapid City Medical Center LLP, Rapid City, South Dakota

Status

Active, not recruiting

Address

Rapid City Medical Center LLP

Rapid City, South Dakota, 57701

Galen Medical Group, Chattanooga, Tennessee

Status

Withdrawn

Address

Galen Medical Group

Chattanooga, Tennessee, 37404

Lonestar Gastroenterology, Austin, Texas

Status

Withdrawn

Address

Lonestar Gastroenterology

Austin, Texas, 78745

DHAT Research Institute, Garland, Texas

Status

Active, not recruiting

Address

DHAT Research Institute

Garland, Texas, 75044

Invesclinic US LLC, McAllen, Texas

Status

Withdrawn

Address

Invesclinic US LLC

McAllen, Texas, 78503

Advanced Research Institute, Ogden, Utah

Status

Active, not recruiting

Address

Advanced Research Institute

Ogden, Utah, 84405

University of Utah Hospital, Salt Lake City, Utah

Status

Withdrawn

Address

University of Utah Hospital

Salt Lake City, Utah, 84132

Verity Research, Inc., Fairfax, Virginia

Status

Active, not recruiting

Address

Verity Research, Inc.

Fairfax, Virginia, 22031

Blue Ridge Medical Research, Lynchburg, Virginia

Status

Active, not recruiting

Address

Blue Ridge Medical Research

Lynchburg, Virginia, 24502

Washington Gastroenterology, Bellevue, Washington

Status

Withdrawn

Address

Washington Gastroenterology

Bellevue, Washington, 98004

International Sites

St. Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia

Status

Active, not recruiting

Address

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010

Swallow Clinic, St George Hospital, Kogarah, New South Wales, Australia

Status

Active, not recruiting

Address

Swallow Clinic, St George Hospital

Kogarah, New South Wales, 2217

John Hunter Hospital, New Lambton, New South Wales, Australia

Status

Active, not recruiting

Address

John Hunter Hospital

New Lambton, New South Wales, 2305

Westmead Children's Hospital, Westmead, New South Wales, Australia

Status

Not yet recruiting

Address

Westmead Children's Hospital

Westmead, New South Wales, 02145

Site Contact

Karol Knoop, RN, BS, CCRA

karol.knoop@ellodipharma.com

(609) 450-1312

Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia

Status

Active, not recruiting

Address

Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112

Box Hill Hospital, Box Hill, Victoria, Australia

Status

Active, not recruiting

Address

Box Hill Hospital

Box Hill, Victoria, 3128

St. Vincent's Hospital, Fitzroy, Victoria, Australia

Status

Withdrawn

Address

St. Vincent's Hospital

Fitzroy, Victoria, 3065

Alfred Hospital, Melbourne, Victoria, Australia

Status

Active, not recruiting

Address

Alfred Hospital

Melbourne, Victoria, 3004

Royal Children's Hospital, Melbourne, Victoria, Australia

Status

Recruiting

Address

Royal Children's Hospital

Melbourne, Victoria, 3052

Site Contact

Karol Knoop, RN, BS, CCRA

karol.knoop@ellodipharma.com

(609) 450-1312

Klinikum rechts der Isar der TU Munchen, Munich, Bavaria, Germany

Status

Withdrawn

Address

Klinikum rechts der Isar der TU Munchen

Munich, Bavaria, 81675

Gastro Campus Research GbR, Münster, NRW, Germany

Status

Withdrawn

Address

Gastro Campus Research GbR

Münster, NRW, 48159

Hosital General de Tomelloso, Tomelloso, Ciudad Real, Spain

Status

Active, not recruiting

Address

Hosital General de Tomelloso

Tomelloso, Ciudad Real, 13700

Barcelona, Spain

Status

Withdrawn

Address

Hospital Universitari Vall de Hebron-VHIR

Barcelona, , 8035

Hospital Universitario de la Princesa, Madrid, Spain

Status

Withdrawn

Address

Hospital Universitario de la Princesa

Madrid, , 28006

Madrid, Spain

Status

Active, not recruiting

Address

Hospital Universitario Ramón y Cajal (Madrid)

Madrid, , 28034

Hospital Universitario Virgen Macarena, Sevilla, Spain

Status

Withdrawn

Address

Hospital Universitario Virgen Macarena

Sevilla, , 41009

Valencia, Spain

Status

Withdrawn

Address

Hospital Clinico Universitario de Valencia

Valencia, , 46010

Hospital Universitario Miguel Servet, Zaragoza, Spain

Status

Withdrawn

Address

Hospital Universitario Miguel Servet

Zaragoza, , 50009

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