Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)

Study Purpose

Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and pathological features of EoE. APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.

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	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Male or female between ≥18 and ≤75 years of age at the time of informed consent.

- Signed informed consent.

- Evidence of EoE defined by ≥15 peak eosinophils per HPF as measured from proximal and distal biopsies.

- Subject-reported history of ≥3 episodes of dysphagia in the 7 days prior to Screening.

- 7-day Global EoE Symptom Score >3 at baseline and at screening.

- Willing and able to adhere to study-related treatment regimens, procedures, and visit schedule.

Exclusion Criteria:

- Have known contraindication, hypersensitivity, or intolerance to corticosteroids; - 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; - Presence of oral or esophageal mucosal infection of any type; - Have any mouth or dental condition that prevents normal eating; - Have any condition affecting the esophageal mucosa or altering esophageal motility other than EoE; - Use of systemic corticosteroids within 60 days prior to Screening, use of inhaled/swallowed corticosteroids within 30 days prior to Screening, or extended use of high-potency dermal topical corticosteroids within 30 days prior to Screening; - Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF); - Morning serum cortisol level ≤5 μg/dL (138 nmol/L); - Use of biologic immunomodulators in the 24 weeks prior to Screening; - Use of calcineurin inhibitors or purine analogues, or potent cytochrome P450 (CYP) 3A4 inhibitors in the 12 weeks prior to Screening; - Have a contraindication to or factors that substantially increase the risk of EGD or esophageal biopsy or have narrowing of the esophagus that precludes EGD with a standard 9 mm endoscope; - Have a history of an esophageal stricture requiring dilatation within the previous 12 weeks prior to Screening; - Have initiated, discontinued or changed dosage regimen of PPIs, H2 antagonists, antacids or antihistamines for any condition such as GERD or allergic rhinitis within 4 weeks prior to qualifying endoscopy.

These drugs must remain constant throughout the study.

- A serum cortisol level <18 μg/dL (497 nmol/L) at 60 minutes with adrenocorticotropic hormone (ACTH) stimulation test using 250 μg cosyntropin (i.e., a positive result on the ACTH stimulation test).

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.	NCT03191864
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 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Adare Pharmaceuticals, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Peter C Richardson
Principal Investigator Affiliation	Adare Pharmaceuticals, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Belgium, Canada, Germany, Spain, Switzerland, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis

Additional Details

FLUTE is a phase 2b randomized, double-blind, placebo-controlled dose-ranging clinical trial of APT-1011 versus placebo in 100 adult subjects (≥18 years of age) diagnosed with EoE. Efficacy (including histologic, endoscopic, and symptomatic response), safety, and PK of APT-1011 will be examined. Participants will be given an electronic diary to record symptoms and medication intake daily. FLUTE will be conducted in several parts (Screening [4 weeks], followed by a 4-week Baseline Symptom Assessment, and 2 treatment parts [Part 1: 14-week Induction and Part 2: 38-week Maintenance]), with a follow-up visit to occur 2 weeks after the final dose of study drug. In Part 1 of the study, 100 subjects will be randomized 1:1:1:1:1 to receive placebo or one of 4 active doses of APT-1011. All subjects will receive one tablet 30 minutes after breakfast and one tablet at bedtime (HS). The dosing groups include: 1.5 mg HS APT-1011, 1.5 mg twice daily (BID) (total daily dose of 3 mg) APT-1011, 3 mg HS APT-1011, and 3 mg BID (total daily dose of 6 mg) APT-1011, and placebo BID. In Part 2, all subjects classified as histologic responders at Week 12 will continue to be treated according to the dosing group to which they were randomized, and non-responders will receive single-blind 3 mg BID. All subjects who are histologic non-responders at Week 26 will stop treatment at Week 28 and enter the 2-week follow-up and exit the study. Histologic responders at Week 26 will continue on the same dose until end-of-study at Week 52. Subjects will complete a follow-up visit 2 weeks after the final dose of study drug. All subjects must have a final EGD within 3 weeks prior to completing the Follow-up Visit unless the subject withdraws consent or has a contraindication to EGD.

Arms & Interventions

Arms

Experimental: APT-1011 1.5 mg HS

Placebo after breakfast, APT-1011 1.5 mg HS

Experimental: APT-1011 1.5 mg BID

APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS

Experimental: APT-1011 3 mg HS

Placebo after breakfast, APT-1011 3 mg HS

Experimental: APT-1011 3 mg BID

APT-1011 3 mg after breakfast, APT-1011 3 mg HS

Placebo Comparator: Placebo BID

Placebo 30 minutes after breakfast and HS

Interventions

Drug: - APT-1011

APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate

Drug: - Placebo

Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.

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.

Del Sol Research Management, LLC, Chandler, Arizona

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Del Sol Research Management, LLC

Chandler, Arizona, 85224

Del Sol Research Management, LLC, Tucson, Arizona

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Del Sol Research Management, LLC

Tucson, Arizona, 85710

Arkansas Gastroenterology, P.A., Sherwood, Arkansas

Status

Address

Arkansas Gastroenterology, P.A.

Sherwood, Arkansas, 72120

Hope Clinical Research, Canoga Park, California

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Address

Hope Clinical Research

Canoga Park, California, 91303

TriWest Research Associates, LLC, El Cajon, California

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Address

TriWest Research Associates, LLC

El Cajon, California, 92020-4124

SC Clinical Research, Inc., Garden Grove, California

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SC Clinical Research, Inc.

Garden Grove, California, 92844

Los Angeles, California

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Beverly Hills Center for Digestive Health

Los Angeles, California, 90048

Focilmed, Oxnard, California

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Focilmed

Oxnard, California, 93030

Precision Research Institute, LLC, San Diego, California

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Precision Research Institute, LLC

San Diego, California, 92114

Medical Associates Research Group, Inc., San Diego, California

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Medical Associates Research Group, Inc.

San Diego, California, 92123

Care Access Research LLC, San Pablo, California

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Care Access Research LLC

San Pablo, California, 94806

Stanford University School of Medicine, Stanford, California

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Stanford University School of Medicine

Stanford, California, 94305-2200

St. Jude Healthcare, Yorba Linda, California

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St. Jude Healthcare

Yorba Linda, California, 92886

Western Connecticut Health Network, Danbury, Connecticut

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Western Connecticut Health Network

Danbury, Connecticut, 06810

Hamden, Connecticut

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Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518

Eastern Research, Inc., Hialeah, Florida

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Eastern Research, Inc.

Hialeah, Florida, 33013

Nature Coast Clinical Research, LLC, Inverness, Florida

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Nature Coast Clinical Research, LLC

Inverness, Florida, 34452

Sunrise Medical Research, Lauderdale Lakes, Florida

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Sunrise Medical Research

Lauderdale Lakes, Florida, 33319

DBC Research, Corp, Pembroke Pines, Florida

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DBC Research, Corp

Pembroke Pines, Florida, 33029

Northwestern Medical Faculty Foundation, Chicago, Illinois

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Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611

Southwest Gastroenterology, Oak Lawn, Illinois

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Southwest Gastroenterology

Oak Lawn, Illinois, 60453-3767

Rockford, Illinois

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Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, 61107

Evansville, Indiana

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MediSphere Medical Research Center, an AMR affiliate

Evansville, Indiana, 47714

Topeka, Kansas

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Cotton-O'Neil Clinical Research Center, Digestive Health

Topeka, Kansas, 66606

Gastroenterology Associates, Hazard, Kentucky

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Gastroenterology Associates

Hazard, Kentucky, 41701

Clinical Trials of America, Inc., West Monroe, Louisiana

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Clinical Trials of America, Inc.

West Monroe, Louisiana, 71291

Henry Ford Medical Center, Novi, Michigan

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Henry Ford Medical Center

Novi, Michigan, 48377-3600

Metro Health, Wyoming, Michigan

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Metro Health

Wyoming, Michigan, 49519

St. Louis Center for Clinical Research, Saint Louis, Missouri

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St. Louis Center for Clinical Research

Saint Louis, Missouri, 63128

Great Neck, New York

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Long Island Gastrointestinal Research Group, LLP

Great Neck, New York, 11023

Weill Cornell Medical College, New York, New York

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Weill Cornell Medical College

New York, New York, 10021

Chapel Hill, North Carolina

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514

Research Institute of the Carolinas, PLC, Mooresville, North Carolina

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Research Institute of the Carolinas, PLC

Mooresville, North Carolina, 28117

Carolina's GI Research, LLC, Raleigh, North Carolina

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Carolina's GI Research, LLC

Raleigh, North Carolina, 27607

Wake Research Associates, LLC, Raleigh, North Carolina

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Wake Research Associates, LLC

Raleigh, North Carolina, 27612

PMG Research of Salisbury, LLC, Salisbury, North Carolina

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PMG Research of Salisbury, LLC

Salisbury, North Carolina, 28144

Bernstein Clinical Research Center, LLC, Cincinnati, Ohio

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Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45231

Aventiv Research Inc., Columbus, Ohio

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Aventiv Research Inc.

Columbus, Ohio, 43231

Unity Clinical Research, Oklahoma City, Oklahoma

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Unity Clinical Research

Oklahoma City, Oklahoma, 73118

Medford, Oregon

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Allergy and Asthma Center of South Oregon

Medford, Oregon, 97504

University of Pennsylvania, Philadelphia, Pennsylvania

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University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Digestive Disease Associates, Ltd., Wyomissing, Pennsylvania

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Digestive Disease Associates, Ltd.

Wyomissing, Pennsylvania, 19610

Rapid City Medical Center, LLP, Rapid City, South Dakota

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Address

Rapid City Medical Center, LLP

Rapid City, South Dakota, 57701

Advanced Gastroenterology, Union City, Tennessee

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Address

Advanced Gastroenterology

Union City, Tennessee, 38261

Avant Research Associates, LLC - Austin, Austin, Texas

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Avant Research Associates, LLC - Austin

Austin, Texas, 78704

Avant Research Associates, LLC, Beaumont, Texas

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Avant Research Associates, LLC

Beaumont, Texas, 77702

DHAT Research Institute, Richardson, Texas

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DHAT Research Institute

Richardson, Texas, 75082

Advanced Research Institute, Ogden, Utah

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Advanced Research Institute

Ogden, Utah, 84405

University of Utah, Salt Lake City, Utah

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University of Utah

Salt Lake City, Utah, 84108

Care Access Research LLC, Salt Lake City, Utah

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Address

Care Access Research LLC

Salt Lake City, Utah, 84124

Verity Research Inc, Fairfax, Virginia

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Address

Verity Research Inc

Fairfax, Virginia, 22031

International Sites

AZ Sint-Lucas, Brugge, Belgium

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AZ Sint-Lucas

Brugge, , 8310

Universitair Ziekenhuis Gent, Gent, Belgium

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Universitair Ziekenhuis Gent

Gent, , 9000

AZ Groeninge - Kennedylaan, Kortrijk, Belgium

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Address

AZ Groeninge - Kennedylaan

Kortrijk, , 8500

UZ Leuven, Leuven, Belgium

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UZ Leuven

Leuven, , 3000

(G.I.R.I.) GI Research Institute, Vancouver, British Columbia, Canada

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(G.I.R.I.) GI Research Institute

Vancouver, British Columbia, V6Z 2K5

Viable Clinical Research, Bridgewater, Nova Scotia, Canada

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Address

Viable Clinical Research

Bridgewater, Nova Scotia, B4V 3N2

Viable Clinical Research, Lindsay, Ontario, Canada

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Address

Viable Clinical Research

Lindsay, Ontario, K9V 5G6

London Health Science Centre, London, Ontario, Canada

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Address

London Health Science Centre

London, Ontario, N6A 5A5

Taunton Surgical Centre, Oshawa, Ontario, Canada

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Address

Taunton Surgical Centre

Oshawa, Ontario, L1H 7K4

Klinikum rechts der Isar der TU Muenchen, Muenchen, Bayern, Germany

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Klinikum rechts der Isar der TU Muenchen

Muenchen, Bayern, 81675

Staedisches Klinikum Brandenburg, Brandenburg an der Havel, Brandenburg, Germany

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Address

Staedisches Klinikum Brandenburg

Brandenburg an der Havel, Brandenburg, 14770

Praxis am Germania, Muenster, Nordrhein Westfalen, Germany

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Praxis am Germania

Muenster, Nordrhein Westfalen, 48159

Universitaetsklinikum Leipzig AoeR, Leipzig, Sachsen, Germany

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Universitaetsklinikum Leipzig AoeR

Leipzig, Sachsen, 4103

Universitaetsklinikum Schleswig-Holstein, Kiel, Schleswig Holstein, Germany

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Universitaetsklinikum Schleswig-Holstein

Kiel, Schleswig Holstein, 24105

Hospital General de Tomelloso, Tomelloso, Ciudad Real, Spain

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Hospital General de Tomelloso

Tomelloso, Ciudad Real, 13700

Alicante, Spain

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Hospital General Universitario de Alicante

Alicante, , 3010

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

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Hospital de la Santa Creu i Sant Pau

Barcelona, , 08025

Hospital Universitari Vall d'Hebron, Barcelona, Spain

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Hospital Universitari Vall d'Hebron

Barcelona, ,

Hospital Universitario de La Princesa, Madrid, Spain

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Hospital Universitario de La Princesa

Madrid, , 28006

Hospital Universitario Virgen del Rocio, Sevilla, Spain

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Hospital Universitario Virgen del Rocio

Sevilla, , 41013

Valencia, Spain

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Hospital Clinico Universitario de Valencia

Valencia, , 46010

Zaragoza, Spain

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Hospital Clinico Universitario Lozano Blesa

Zaragoza, , 50009

Hospital Universitario Miguel Servet, Zaragoza, Spain

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Hospital Universitario Miguel Servet

Zaragoza, , 50009

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

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Centre Hospitalier Universitaire Vaudois

Lausanne, , 1011

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