APT-1011 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
98好酸球性消化管疾患10

98. 好酸球性消化管疾患


臨床試験数 : 172 薬物数 : 149 - (DrugBank : 39) / 標的遺伝子数 : 38 - 標的パスウェイ数 : 135
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT05634746
(ClinicalTrials.gov)
December 29, 202222/11/202224-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3)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 EsophagitisEosinophilic EsophagitisDrug: APT-1011;Drug: Placebo oral tabletEllodi Pharmaceuticals, LPNULLRecruiting18 YearsN/AAll200Phase 3United States
2NCT05095116
(ClinicalTrials.gov)
February 10, 202214/10/2021Expanded Access Protocol for Patients With Eosinophilic EsophagitisAPT-1011 (Fluticasone ODT) Expanded Access Protocol for Patients With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: APT-1011 3 mg HSEllodi Pharmaceuticals, LPNULLAvailable12 YearsN/AAllUnited States
3NCT05083312
(ClinicalTrials.gov)
September 30, 20216/10/2021Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 TrialAn Adolescent Sub-study Within FLUTE-2: A Randomized, Double-blind, Placebo-Controlled Study of APT-1011 (Fluticasone Propionate Oral Dispersible Tablet Formulation), With an Open-label Extension, in Adolescent Subjects With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: APT-1011;Drug: Placebo oral tabletEllodi Pharmaceuticals, LPNULLCompleted12 Years17 YearsAll5Phase 3United States;Australia
4EUCTR2019-001521-27-DE
(EUCTR)
03/08/202010/02/2020Study with Eosinophilic Esophagitis subjectsFluticasone propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 in Adult and Adolescent Subjects with Eosinophilic Esophagitis - FLUTE-2 Eosinophilic Esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: APT-1011
Product Code: APT-1011 - 3 mg
INN or Proposed INN: Fluticasone Propionate, USP
Other descriptive name: FLUTICASONE PROPIONATE
Adare Pharmaceuticals US, LPNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;Spain;Australia;Germany
5EUCTR2019-001521-27-ES
(EUCTR)
04/04/202028/02/2020Study with Eosinophilic Esophagitis subjectsFluticasone propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 in Adult and Adolescent Subjects with Eosinophilic Esophagitis - FLUTE-2 Eosinophilic Esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: APT-1011
Product Code: APT-1011 - 3 mg
INN or Proposed INN: Fluticasone Propionate, USP
Other descriptive name: FLUTICASONE PROPIONATE
Adare Pharmaceuticals US, LPNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Spain;Australia;Germany;Switzerland
6NCT04281108
(ClinicalTrials.gov)
January 30, 202020/2/2020Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)Fluticasone Propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 With an Open-label Extension, in Adult Subjects With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: APT-1011;Drug: Placebo oral tabletEllodi Pharmaceuticals, LPNULLCompleted18 YearsN/AAll143Phase 3United States;Australia;Spain;Germany
7EUCTR2016-004749-10-DE
(EUCTR)
15/11/201726/07/2017study in subjects with Eosinophilic EsophagitisFLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis. Eosinophilic Esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: APT-1011
INN or Proposed INN: FLUTICASONE PROPIONATE
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
Other descriptive name: FLUTICASONE PROPIONATE
Adare PharmaceuticalNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Canada;Spain;Belgium;Germany;Switzerland
8EUCTR2016-004749-10-BE
(EUCTR)
06/10/201707/07/2017study in subjects with Eosinophilic EsophagitisFLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis. Eosinophilic Esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: APT-1011
INN or Proposed INN: FLUTICASONE PROPIONATE
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
Other descriptive name: FLUTICASONE PROPIONATE
Adare PharmaceuticalNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Spain;Belgium;Germany;Switzerland
9EUCTR2016-004749-10-ES
(EUCTR)
20/09/201720/09/2017study in subjects with Eosinophilic EsophagitisFLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis. Eosinophilic Esophagitis
MedDRA version: 20.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000013492;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: APT-1011
INN or Proposed INN: Fluticasone Propionate
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
INN or Proposed INN: Fluticasone Propionate
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
INN or Proposed INN: Fluticasone Propionate
Other descriptive name: FLUTICASONE PROPIONATE
Adare PharmaceuticalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Canada;Belgium;Spain;Germany
10NCT03191864
(ClinicalTrials.gov)
June 22, 201715/6/2017Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)FLUTicasone in Eosinophilic Esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: APT-1011;Drug: PlaceboAdare Pharmaceuticals, Inc.NULLCompleted18 Years75 YearsAll106Phase 2United States;Belgium;Canada;Germany;Spain;Switzerland