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

PHASE3CompletedINTERVENTIONAL
Enrollment

143

Participants

Timeline

Start Date

January 30, 2020

Primary Completion Date

May 5, 2022

Study Completion Date

October 24, 2022

Conditions
Eosinophilic Esophagitis
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.

PROCEDURE

Esophagogastroduodenoscopy

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.

Trial Locations (56)

2010

St. Vincent's Hospital Sydney, Darlinghurst

2217

Swallow Clinic, St George Hospital, Kogarah

2305

John Hunter Hospital, New Lambton

3004

Alfred Hospital, Melbourne

3065

St. Vincent's Hospital, Fitzroy

5112

Lyell McEwin Hospital, Elizabeth Vale

11023

Long Island Gastrointestinal Research Group LLP, Great Neck

13700

Hosital General de Tomelloso, Tomelloso

19104

Perelman Center for Advanced Medicine, Philadelphia

19610

Digestive Disease Associates LTD, Wyomissing

20815

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

21045

Gastro Center of Maryland, Columbia

22031

Verity Research, Inc., Fairfax

24502

Blue Ridge Medical Research, Lynchburg

27599

University of North Carolina Health Systems (UNC Hospital), Chapel Hill

27834

Carolina Research, Greenville

28034

Hospital Universitario Ramón y Cajal (Madrid), Madrid

30607

Summit Clinical Research, Athens

32003

Fleming Island Center for Clinical Research, Fleming Island

32256

Encore Borland Groover Clinical Research, Jacksonville

32803

Endoscopic Research, Inc., Orlando

33029

DBC Research USA, Pembroke Pines

34452

Nature Coast Clinical Research, Inverness

36207

Pinnacle Research Group, LLC, Anniston

36305

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

36606

East View Medical Research, LLC, Mobile

44060

Great Lakes Gastroenterology Research, LLC, Mentor

44145

Northshore Gastroenterology Research, LLC, Westlake

45219

Consultants for Clinical Research, Cincinnati

45231

Bernstein Clinical Research Center, LLC, Cincinnati

48047

Clinical Research Institute of Michigan LLC, Chesterfield

48109

Michigan Medicine, University of Michigan, Ann Arbor

48377

Henry Ford Health System, Novi

49519

West Michigan Clinical Research Center, Wyoming

52242

University of Iowa Hospitals and Clinics, Iowa City

55446

Minnesota Gastroenterology, P.A., Plymouth

55905

Mayo Clinic, Rochester

57701

Rapid City Medical Center LLP, Rapid City

59715

Bozeman Health GI Clinic, Bozeman

63005

Clinical Research Professionals, Chesterfield

72117

Arkansas Gastroenterology, North Little Rock

72211

Preferred Research Partners Inc., Little Rock

74136

Vital Prospects Clinical Research Institute, P.C., Tulsa

75044

DHAT Research Institute, Garland

80033

Western States Clinical Research Inc., Wheat Ridge

80907

Asthma and Allergy Associates, PC, Colorado Springs

Peak Gastroenterology Associates, Colorado Springs

84405

Advanced Research Institute, Ogden

85712

Del Sol Research Management, LLC, Tucson

91303

Hope Clinical Research, Canoga Park

91345

Facey Medical Foundation, Mission Hills

92123

Medical Associates Research Group, San Diego

92563

United Medical Doctors, Murrieta

93012

Camarillo Endoscopy Center, Camarillo

06810

Western Connecticut Medical Group - Gastroenterology, Danbury

06518

Medical Research Center of Connecticut, LLC, Hamden

Sponsors
All Listed Sponsors
lead

Ellodi Pharmaceuticals, LP

INDUSTRY