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

PHASE2CompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

June 22, 2017

Primary Completion Date

January 3, 2019

Study Completion Date

October 23, 2019

Conditions
Eosinophilic Esophagitis
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.

Trial Locations (75)

1011

Centre Hospitalier Universitaire Vaudois, Lausanne

3000

UZ Leuven, Leuven

3010

Hospital General Universitario de Alicante, Alicante

4103

Universitaetsklinikum Leipzig AoeR, Leipzig

8310

AZ Sint-Lucas, Bruges

8500

AZ Groeninge - Kennedylaan, Kortrijk

9000

Universitair Ziekenhuis Gent, Ghent

10021

Weill Cornell Medical College, New York

11023

Long Island Gastrointestinal Research Group, LLP, Great Neck

13700

Hospital General de Tomelloso, Tomelloso

14770

Staedisches Klinikum Brandenburg, Brandenburg

19104

University of Pennsylvania, Philadelphia

19610

Digestive Disease Associates, Ltd., Wyomissing

22031

Verity Research Inc, Fairfax

24105

Universitaetsklinikum Schleswig-Holstein, Kiel

27514

University of North Carolina at Chapel Hill, Chapel Hill

27607

Carolina's GI Research, LLC, Raleigh

27612

Wake Research Associates, LLC, Raleigh

28006

Hospital Universitario de La Princesa, Madrid

28117

Research Institute of the Carolinas, PLC, Mooresville

28144

PMG Research of Salisbury, LLC, Salisbury

33013

Eastern Research, Inc., Hialeah

33029

DBC Research, Corp, Pembroke Pines

33319

Sunrise Medical Research, Lauderdale Lakes

34452

Nature Coast Clinical Research, LLC, Inverness

38261

Advanced Gastroenterology, Union City

41013

Hospital Universitario Virgen del Rocio, Seville

41701

Gastroenterology Associates, Hazard

43231

Aventiv Research Inc., Columbus

45231

Bernstein Clinical Research Center, LLC, Cincinnati

46010

Hospital Clinico Universitario de Valencia, Valencia

47714

MediSphere Medical Research Center, an AMR affiliate, Evansville

48159

Praxis am Germania, Münster

49519

Metro Health, Wyoming

50009

Hospital Clinico Universitario Lozano Blesa, Zaragoza

Hospital Universitario Miguel Servet, Zaragoza

57701

Rapid City Medical Center, LLP, Rapid City

60611

Northwestern Medical Faculty Foundation, Chicago

61107

Rockford Gastroenterology Associates, Ltd., Rockford

63128

St. Louis Center for Clinical Research, St Louis

66606

Cotton-O'Neil Clinical Research Center, Digestive Health, Topeka

71291

Clinical Trials of America, Inc., West Monroe

72120

Arkansas Gastroenterology, P.A., Sherwood

73118

Unity Clinical Research, Oklahoma City

75082

DHAT Research Institute, Richardson

77702

Avant Research Associates, LLC, Beaumont

78704

Avant Research Associates, LLC - Austin, Austin

81675

Klinikum rechts der Isar der TU Muenchen, Munich

84108

University of Utah, Salt Lake City

84124

Care Access Research LLC, Salt Lake City

84405

Advanced Research Institute, Ogden

85224

Del Sol Research Management, LLC, Chandler

85710

Del Sol Research Management, LLC, Tucson

90048

Beverly Hills Center for Digestive Health, Los Angeles

91303

Hope Clinical Research, Canoga Park

92114

Precision Research Institute, LLC, San Diego

92123

Medical Associates Research Group, Inc., San Diego

92844

SC Clinical Research, Inc., Garden Grove

92886

St. Jude Healthcare, Yorba Linda

93030

Focilmed, Oxnard

94806

Care Access Research LLC, San Pablo

97504

Allergy and Asthma Center of South Oregon, Medford

92020-4124

TriWest Research Associates, LLC, El Cajon

94305-2200

Stanford University School of Medicine, Stanford

06810

Western Connecticut Health Network, Danbury

06518

Medical Research Center of Connecticut, LLC, Hamden

60453-3767

Southwest Gastroenterology, Oak Lawn

48377-3600

Henry Ford Medical Center, Novi

V6Z 2K5

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

B4V 3N2

Viable Clinical Research, Bridgewater

K9V 5G6

Viable Clinical Research, Lindsay

N6A 5A5

London Health Science Centre, London

L1H 7K4

Taunton Surgical Centre, Oshawa

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

Unknown

Hospital Universitari Vall d'Hebron, Barcelona

Sponsors
All Listed Sponsors
lead

Adare Pharmaceuticals, Inc.

INDUSTRY

NCT03191864 - Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) | Biotech Hunter | Biotech Hunter