98. 好酸球性消化管疾患 Eosinophilic gastrointestinal disease Clinical trials / Disease details


臨床試験数 : 171 薬物数 : 184 - (DrugBank : 47) / 標的遺伝子数 : 42 - 標的パスウェイ数 : 141

  
No.TrialIDDate_
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PhaseCountries
1JPRN-jRCT2021210067
07/03/202202/02/2022A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT JAPANESE SUBJECTS WITH EOSINOPHILIC GASTROENTERITISA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT JAPANESE SUBJECTS WITH EOSINOPHILIC GASTROENTERITIS Eosinophilic gastroenteritisCC-93538 is administered subcutaneously at a dose of 360 mg weekly in adults and adolescents of 12 years of age or older.After 16 weeks after the initial administration,a dose of 360 mg is administered subcutaneously weekly or bi-weekly.During the OLE phase,360 mg will be administered subcutaneously weekly.Zhang ChangliangNULLPending>= 12age old<= 75age oldBoth45Phase 3Japan
2NCT05246085
(ClinicalTrials.gov)
March 1, 20221/2/2022Evaluating Adrenal Insufficiency in Adults With Eosinophilic Esophagitis on Chronic Swallowed Topical SteroidsEvaluating Adrenal Insufficiency in Adults With Eosinophilic Esophagitis on Chronic Swallowed Topical SteroidsEosinophilic EsophagitisDiagnostic Test: Cortisol levelUniversity of Colorado, DenverNULLNot yet recruiting18 Years85 YearsAll300NULL
3NCT05247866
(ClinicalTrials.gov)
March 202221/12/2021Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic EsophagitisEfficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic EsophagitisEosinophilic EsophagitisDietary Supplement: EoE food introduction-1st;Dietary Supplement: E0E food introduction-2nd;Dietary Supplement: EoE Food introduction-3rd dose;Drug: DupilumabChildren's Hospital of PhiladelphiaRegeneron Pharmaceuticals;Genzyme, a Sanofi CompanyNot yet recruiting6 Years25 YearsAll30Phase 4United States
4EUCTR2020-004335-24-PT
(EUCTR)
24/02/202203/12/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
259Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
5JPRN-jRCT2031210574
10/02/202222/01/2022A PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITISA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS eosinophilic esophagitisAll subjects will be administered CC-93538 at a dose of
360 mg SC once weekly.
Zhang ChangliangNULLPending>= 12age old<= 75age oldBoth22Phase 3United States of America;Canada;United Kingdom;Italy;Israel;Portugal;Germany;Switzerland;Poland;Spain;Austria;Belgium;Australia;Argentina;Japan
6EUCTR2020-004335-24-IT
(EUCTR)
08/02/202229/10/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multicenter, Multinational, Open-Label Extension Study to evaluate the Long-Term Safety of CC-93538 in adult and adolescent subjects with Eosinophilic Esophagitis - - EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: Cendakimab
Product Name: Cendakimab
Product Code: [CC-93538]
INN or Proposed INN: Cendakimab
CELGENE INTERNATIONAL II SàRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
259Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
7NCT04835168
(ClinicalTrials.gov)
January 30, 202210/3/2021Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic EsophagitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic EsophagitisEosinophilic EsophagitisDrug: BT-11 500mg;Drug: BT-11 1000mg;Drug: BT-11 PlaceboLandos Biopharma Inc.NULLNot yet recruiting18 Years65 YearsAll36Phase 1NULL
8NCT05251909
(ClinicalTrials.gov)
January 18, 20226/8/2021Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)Eosinophilic Gastritis;Eosinophilic GastroenteritisBiological: Benralizumab;Biological: PlaceboAstraZenecaNULLRecruiting12 Years130 YearsAll230Phase 3United States;Australia;Brazil;Canada;France;Germany;Italy;Japan;Netherlands;Poland;Spain;Ukraine;Vietnam
9EUCTR2020-004335-24-DE
(EUCTR)
14/01/202230/07/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
259Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
10JPRN-jRCT2031210500
14/01/202218/12/2021Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (HUDSON GI)A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) - HUDSON GI Eosinophilic gastritis, Eosinophilic gastroenteritisThe patients are planned to be randomly assigned to receive either a fixed SC dose of Benralizumab or placebo once monthly in a 24 week double-blind period followed by assessments during an open-label Benralizumab treatment period.Hibi KazushigeNULLRecruiting>= 12age old<= 130age oldBoth230Phase 3Australia;China;Vietnam;Italy;France;Poland;Spain;Brazil;Canada;America;Netherlands;Ukraine;Israel;Japan
11EUCTR2020-004336-16-ES
(EUCTR)
12/01/202212/01/2022A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
12EUCTR2020-001314-37-PT
(EUCTR)
26/11/202112/02/2021Clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagusDouble-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis - Once daily versus twice daily budesonide orodispersible tablets for induction of remission in EoE eosinophilic esophagitis
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 2 mg orodispersible tablets (BUL 2 mg)
INN or Proposed INN: BUDESONIDE
Trade Name: Jorveza 1 mg orodispersible tablets
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
242Phase 3Portugal;Spain;Austria;Germany;Switzerland
13NCT05084963
(ClinicalTrials.gov)
October 29, 202130/9/2021A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic EsophagitisA Phase 2a, Double-blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of IRL201104 in Adult Participants With Active Eosinophilic Esophagitis (EoE)Eosinophilic EsophagitisDrug: IRL201104;Drug: PlaceboRevolo BiotherapeuticsNULLRecruiting18 Years75 YearsAll36Phase 2United States
14NCT05083312
(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, LPNULLRecruiting12 Years17 YearsAll30Phase 3United States;Australia
15EUCTR2020-004336-16-DE
(EUCTR)
29/09/202101/02/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
16EUCTR2020-004336-16-PT
(EUCTR)
24/09/202101/04/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
17NCT04991935
(ClinicalTrials.gov)
September 14, 202128/7/2021Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic EsophagitisA Phase 3, Multi-Center, Multi-National, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Active Eosinophilic Esophagitis.Eosinophilic EsophagitisDrug: CC-93538CelgeneNULLRecruiting12 Years75 YearsAll259Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Germany;Israel;Italy;Japan;Poland;Portugal;Spain;Switzerland;United Kingdom
18EUCTR2021-002288-24-NL
(EUCTR)
10/08/202127/07/2021Effect of citalopram on chest pain in patients with chest pain of unkown originEffect of citalopram on chest pain in patients with functional chest pain - Ci-FCP Chest pain can be divided in cardiac or non-cardiac chest pain (NCCP). To establish the diagnosis NCCP, acute coronary disease has to be ruled out first. NCCP can be caused by functional chest pain (FCP). NCCP in the absence of musculoskeletal abnormalities, major esophageal motor disorders, gastroesophageal reflux or eosinophilic esophagitis is called FCP.;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Trade Name: Citalopram
Product Name: Citalopram
Amsterdam UMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 4Netherlands
19EUCTR2017-003516-39-ES
(EUCTR)
22/07/202114/06/2021A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remissionDouble-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining clinico-histological remission Maintenance of remission in 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]
Trade Name: Jorveza 1 mg orodispersible tablets
Product Name: Budesonide 1 mg orodispersible tablets
Product Code: BUL 1 mg
INN or Proposed INN: BUDESONIDE
Trade Name: Jorveza 0.5 mg orodispersible tablets
Product Name: Budesonide 0.5 mg orodispersible tablets
Product Code: BUL 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3Spain;Germany;Switzerland;Italy
20EUCTR2020-004336-16-PL
(EUCTR)
21/07/202112/05/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Poland;Belgium;Australia;Germany;Japan;New Zealand
21EUCTR2017-003516-39-IT
(EUCTR)
09/07/202117/08/2021A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remissionDouble-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining clinico-histological remission - Episodic and continuous treatment with budesonide orodispersible tablets versus placebo for maintena Maintenance of remission in 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]
Trade Name: Jorveza 1 mg compresse orodispersibili
Product Name: Budesonide 1 mg compresse orodispersibili
Product Code: [BUL 1 mg]
INN or Proposed INN: BUDESONIDE
Trade Name: Jorveza 0.5 mg compresse orodispersibili
Product Name: Budesonide 0.5 mg compresse orodispersibili
Product Code: [BUL 0.5 mg]
INN or Proposed INN: BUDESONIDE
DR. FALK PHARMA GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3Spain;Germany;Switzerland;Italy
22JPRN-jRCT2051200140
01/07/202119/02/2021A Phase 3, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic EsophagitisA Phase 3, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis Eosinophilic esophagitisCC-93538 is administered subcutaneously at a dose of 360 mg weekly in adults and adolescent 12 years of age or older. After 24 weeks after the initial dose, a dose of 360 mg is administered subcutaneously weekly or biweekly.Hatano BenNULLRecruiting>= 12age old<= 75age oldBoth33Phase 3United States of America;Canada;UK;Italy;Israel;Portugal;Germany;Switzerland;Poland;Spain;Austria;Belgium;Australia;Argentina;Japan
23NCT04849390
(ClinicalTrials.gov)
June 29, 20212/4/2021A Study to Investigate the Efficacy and Tolerability of ESO-101 in Patients With Eosinophilic EsophagitisA Randomized, Placebo-controlled, Double-blind Trial Evaluating the Efficacy, Tolerability and Safety of ESO-101 in Adult Patients With Active Eosinophilic EsophagitisEosinophilic EsophagitisDrug: ESO-101;Drug: PlaceboEsoCap AGFGK Clinical Research GmbH;FGK Representative Service B.V.Recruiting18 Years70 YearsAll42Phase 2Germany;Netherlands;Spain;Switzerland
24EUCTR2020-004336-16-IT
(EUCTR)
17/06/202108/06/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC-93538 in adult and adolescent subjects with eosinophilic esophagitis - - EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: [CC-93538]
INN or Proposed INN: Cendakimab
CELGENE INTERNATIONAL II SàRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
25NCT04856891
(ClinicalTrials.gov)
May 20, 202120/4/2021A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic DuodenitisA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Duodenitis Who Have an Inadequate Response With, Lost Response to, or Were Intolerant to Standard TherapiesEosinophilic Duodenitis;Eosinophilic GastroenteritisDrug: AK002;Other: PlaceboAllakos, Inc.NULLActive, not recruiting18 Years80 YearsAll94Phase 3United States
26NCT03678545
(ClinicalTrials.gov)
May 14, 20216/8/2018Dupilumab in Eosinophilic GastritisA Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Dupilumab (Anti-IL4a) in Subjects With Eosinophilic GastritisEosinophilic Gastritis;Eosinophilic GastroenteritisDrug: Dupilumab (blinded);Drug: Placebo (blinded);Drug: Dupilumab (open-label)Children's Hospital Medical Center, CincinnatiRegeneron Pharmaceuticals;National Institutes of Health (NIH)Recruiting12 Years70 YearsAll40Phase 2United States
27EUCTR2020-001314-37-AT
(EUCTR)
06/05/202101/03/2021clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagusDouble-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis eosinophilic esophagitis
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 2 mg orodispersible tablets (BUL 2 mg)
INN or Proposed INN: BUDESONIDE
Trade Name: Jorveza
Product Name: Budesonide 1 mg orodispersible tablets (BUL 1 mg)
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
242Phase 3Portugal;Canada;Spain;Austria;Russian Federation;Germany;Switzerland
28EUCTR2020-003226-23-DE
(EUCTR)
05/05/202121/12/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with eosinophilic esophagitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects with Eosinophilic Esophagitis - VOYAGE Eosinophilic Esophagitis (EoE)
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: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;France;Spain;Belgium;Australia;Netherlands;Germany;Switzerland
29EUCTR2017-003516-39-DE
(EUCTR)
28/04/202121/12/2020A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remissionDouble-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining clinico-histological remission Maintenance of remission in 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]
Trade Name: Jorveza 1 mg orodispersible tablets
Product Name: Budesonide 1 mg orodispersible tablets
Product Code: BUL 1 mg
INN or Proposed INN: BUDESONIDE
Trade Name: Jorveza 0.5 mg orodispersible tablets
Product Name: Budesonide 0.5 mg orodispersible tablets
Product Code: BUL 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3Spain;Germany;Switzerland;Italy
30EUCTR2020-001314-37-DE
(EUCTR)
26/04/202127/11/2020clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagusDouble-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis eosinophilic esophagitis
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 2 mg orodispersible tablets (BUL 2 mg)
INN or Proposed INN: BUDESONIDE
Trade Name: Jorveza
Product Name: Budesonide 1 mg orodispersible tablets (BUL 1 mg)
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
242Phase 3Portugal;Canada;Spain;Austria;Russian Federation;Germany;Switzerland
31NCT02873468
(ClinicalTrials.gov)
April 202116/8/2016Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic EsophagitisRandomized, Double-blind, Multicentric, Parallel, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Florence 30 µg/mL;Drug: Florence 60 µg/mL;Drug: Florence 90 µg/mL;Other: PlaceboEMSNULLNot yet recruiting18 YearsN/AAll116Phase 2NULL
32NCT04776694
(ClinicalTrials.gov)
March 29, 202125/2/2021Compassionate Use of DupilumabBullous Pemphigoid;Eosinophilic Esophagitis (EoE);Pediatric Asthma;Pediatric and Adolescent Chronic Rhinosinusitis With Nasal Polyps (CRSwNP);Pediatric Atopic DermatitisDrug: DupilumabRegeneron PharmaceuticalsNULLAvailableNULL
33NCT04682639
(ClinicalTrials.gov)
February 23, 202119/12/2020A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic EsophagitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Etrasimod;Drug: PlaceboArena PharmaceuticalsNULLRecruiting18 Years65 YearsAll96Phase 2United States;Australia;Belgium;Netherlands;Spain;Switzerland
34EUCTR2020-003226-23-NL
(EUCTR)
22/02/202126/11/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with eosinophilic esophagitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects with Eosinophilic Esophagitis - VOYAGE Eosinophilic Esophagitis (EoE)
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: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;Spain;Belgium;Australia;Germany;Netherlands;Switzerland
35NCT04753697
(ClinicalTrials.gov)
February 22, 20215/2/2021A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic EsophagitisA Phase 3, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: CC-93538;Other: PlaceboCelgeneNULLRecruiting12 Years75 YearsAll399Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Germany;Israel;Italy;Japan;Poland;Portugal;Spain;Switzerland;United Kingdom;Puerto Rico
36EUCTR2020-003226-23-BE
(EUCTR)
02/02/202123/11/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with eosinophilic esophagitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects with Eosinophilic Esophagitis - VOYAGE Eosinophilic Esophagitis (EoE)
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: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;France;Spain;Belgium;Australia;Netherlands;Germany;Switzerland
37EUCTR2020-000082-16-DE
(EUCTR)
21/01/202129/07/2020A study to investigate the efficacy and tolerability of the drug ESO-101 in adult patients with inflammation of the esophagusA randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitis Active eosinophilic esophagitis
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ESO-101
Product Code: ESO-101
INN or Proposed INN: mometasone
Other descriptive name: MOMETASONE FUROATE
EsoCap AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2Spain;Netherlands;Germany;Switzerland
38NCT04620811
(ClinicalTrials.gov)
December 3, 20203/11/2020An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Efficacy and Safety of AK002 in Patients That Were Previously Enrolled in AK002-016 or AK002-012 Studies and Have Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)Eosinophilic Gastritis;Eosinophilic DuodenitisDrug: lirentelimabAllakos, Inc.NULLEnrolling by invitation18 Years80 YearsAll170Phase 3United States
39EUCTR2020-000082-16-NL
(EUCTR)
29/10/202003/09/2020A study to investigate the efficacy and tolerability of the drug ESO-101 in adult patients with inflammation of the esophagusA randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitis Active eosinophilic esophagitis
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ESO-101
Product Code: ESO-101
INN or Proposed INN: mometasone
Other descriptive name: MOMETASONE FUROATE
EsoCap AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2Spain;Germany;Netherlands;Switzerland
40NCT04149470
(ClinicalTrials.gov)
October 7, 202030/10/2019Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)Eosinophilic EsophagitisDrug: Omeprazole 20mg BIDUniversity of Colorado, DenverChildren's Hospital ColoradoRecruiting8 Years22 YearsAll90Phase 4United States
41NCT04593251
(ClinicalTrials.gov)
September 28, 202013/10/2020Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic EsophagitisA Multicentre, SAD, and MAD Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IV Treatment of CALY-002 in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic EsophagitisEosinophilic Esophagitis;Celiac DiseaseBiological: CALY-002;Biological: PlaceboCalypso Biotech BVNULLRecruiting18 YearsN/AAll95Phase 1Belgium;Germany;Netherlands
42NCT04543409
(ClinicalTrials.gov)
September 22, 202018/8/2020A Study of Benralizumab in Patients With Eosinophilic EsophagitisA Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic EsophagitisEosinophilic EsophagitisBiological: Benralizumab;Biological: Matching placeboAstraZenecaNULLRecruiting12 Years65 YearsAll170Phase 3United States;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;United Kingdom
43JPRN-jRCT2061200026
22/09/202004/11/2020A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic EsophagitisThe aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. The effect of doses of benralizumab on EoE histologic signs and symptoms will be assessed over a 52-week treatment period (including a 24-week double-blind placebo-controlled treatment period and a 28-week open-label treatment period). It is proposed that benralizumab will deplete eosinophils from GI tissue(s), improve the symptoms of dysphagia, and improve endoscopy scores as well as other markers of disease activity. Upon completion of the initial 52-week treatment period, patients will be offered an additional Open Label Extension period of at least 1 year, with benralizumab treatment and ongoing study assessments. - MESSINA Eosinophilic Esophagitis
D3255C00001
Biological: Benralizumab
Solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume.
Biological: Matching placebo
Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC), 1 mL fill volume
Hibi KazushigeNULLRecruiting>= 12age old<= 65age oldBoth170Phase 3Canada;France;Germany;Israel;Italy;Netherlands;Poland;Russia;Spain;UK;US;Japan
44NCT04394351
(ClinicalTrials.gov)
September 1, 20207/5/2020Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic EsophagitisEosinophilic Esophagitis (EoE)Drug: Dupilumab;Drug: Matching PlaceboRegeneron PharmaceuticalsSanofiActive, not recruiting1 Year11 YearsAll102Phase 3United States;Canada
45EUCTR2019-001521-27-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
46EUCTR2019-004391-19-NL
(EUCTR)
30/07/202013/05/2020Study to Evaluate the Efficacy and Safety of AK002 in Subjects with Active Eosinophilic EsophagitisA Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safetyof AK002 in Adult and Adolescent Subjects with Active Eosinophilic Esophagitis Active Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: AK002
INN or Proposed INN: not available
Allakos Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2;Phase 3United States;Australia;Netherlands
47NCT04248712
(ClinicalTrials.gov)
July 10, 202028/1/2020Antihistamines in Eosinophilic EsophagitisA Phase II, Randomized, Placebo-controlled Study Evaluating the Efficacy of Antihistamines in the Treatment of Eosinophilic Esophagitis (the ATEE Study)Eosinophilic EsophagitisDrug: Famotidine;Drug: Loratadine;Drug: PlaceboMayo ClinicNULLRecruiting18 YearsN/AAll50Phase 2United States
48EUCTR2019-002871-32-FR
(EUCTR)
06/07/202011/05/2020A Study of Benralizumab in Patients with Eosinophilic EsophagitisA Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify
Product Name: benralizumab
Product Code: MEDI-563
INN or Proposed INN: benralizumab
Other descriptive name: benralizumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3United States;France;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
49NCT04322708
(ClinicalTrials.gov)
July 6, 202024/3/2020A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic EsophagitisA Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab (AK002) in Adult and Adolescent Patients With Active Eosinophilic EsophagitisEosinophilic EsophagitisOther: Placebo;Drug: lirentelimab (AK002)Allakos, Inc.NULLActive, not recruiting12 Years80 YearsAll277Phase 2/Phase 3United States;Australia;Netherlands
50NCT04322604
(ClinicalTrials.gov)
June 18, 202024/3/2020A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)Eosinophilic Gastritis;Eosinophilic DuodenitisDrug: lirentelimab (AK002);Other: PlaceboAllakos, Inc.NULLActive, not recruiting18 Years80 YearsAll180Phase 3United States
51EUCTR2019-002871-32-IT
(EUCTR)
11/05/202031/08/2021A Study of Benralizumab in Patients with Eosinophilic EsophagitisA Multicenter, Randomized, Double-blind, Parallel-group, Placebocontrolled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA Eosinophilic Esophagitis (EoE)
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: benralizumab
Product Code: [MEDI-563]
INN or Proposed INN: benralizumab
ASTRAZENECA ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3France;United States;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
52EUCTR2019-002871-32-DE
(EUCTR)
09/04/202027/01/2020A Study of Benralizumab in Patients with Eosinophilic EsophagitisA Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify
Trade Name: Fasenra
Product Name: benralizumab
Product Code: MEDI-563
INN or Proposed INN: benralizumab
Other descriptive name: benralizumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3France;United States;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy;Japan
53EUCTR2019-001521-27-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
54EUCTR2017-003737-29-NL
(EUCTR)
01/04/202009/04/2019Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis Active eosinophilic esophagitis and maintenance of remission in 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: Budesonide oral suspension [0.2 mg/ml]
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2;Phase 3Portugal;Greece;Spain;Israel;Germany;Netherlands;United Kingdom
55EUCTR2019-002871-32-NL
(EUCTR)
02/03/202008/01/2020A Study of Benralizumab in Patients with Eosinophilic EsophagitisA Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify
Trade Name: Fasenra
Product Name: benralizumab
Product Code: MEDI-563
INN or Proposed INN: benralizumab
Other descriptive name: benralizumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3France;United States;Canada;Spain;Poland;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Italy;Japan
56EUCTR2019-002871-32-GB
(EUCTR)
24/02/202018/03/2020A Study of Benralizumab in Patients with Eosinophilic EsophagitisA Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify
Product Name: benralizumab
Product Code: MEDI-563
INN or Proposed INN: benralizumab
Other descriptive name: benralizumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3United Kingdom;Italy;Japan;Germany;Netherlands;Israel;Russian Federation;Poland;Spain;Canada;France;United States
57EUCTR2019-002871-32-ES
(EUCTR)
05/02/202020/12/2019A Study of Benralizumab in Patients with Eosinophilic EsophagitisA Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify
Product Name: benralizumab
Product Code: MEDI-563
INN or Proposed INN: benralizumab
Other descriptive name: benralizumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3United States;France;Canada;Poland;Spain;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
58NCT04281108
(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, LPNULLActive, not recruiting18 YearsN/AAll143Phase 3Germany;United States;Spain;Australia
59EUCTR2019-002691-14-IT
(EUCTR)
30/10/201924/05/2021Oral viscous budesonide administration for 3 months in a population of patients affected by esophageal atresia and eosinophilic esophagitis.VISCOUS BUDESONIDE IN PATIENTS AFFECTED BY EOSINOPHILIC ESOPHAGITIS, OPERATED FOR ESOPHAGEAL ATRESIA - na Eosinophilicesophagitis (EoE) in Esophageal atresia (EA).
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide
Product Code: [na]
INN or Proposed INN: Budesonide
Product Name: Budesonide
Product Code: [na]
INN or Proposed INN: Budesonide
Product Name: Budesonide
Product Code: [na]
INN or Proposed INN: Budesonide
IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMANULLNot RecruitingFemale: yes
Male: yes
9Phase 2Italy
60EUCTR2018-000844-25-DE
(EUCTR)
21/10/201913/11/2018A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
61EUCTR2018-000844-25-SE
(EUCTR)
09/10/201915/11/2018A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
290Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
62NCT03615950
(ClinicalTrials.gov)
October 1, 201924/7/2018Effects of Swallowed Steroids on Bone Density and Growth in Pediatric Eosinophilic EsophagitisEffects of Swallowed Corticosteroids on Bone Mineral Density and Growth Velocity in Children With Eosinophilic EsophagitisEosinophilic EsophagitisDiagnostic Test: Bone Mineral Density (DEXA) scan;Diagnostic Test: Vitamin D Measurement;Diagnostic Test: Height measurement;Other: Assessment of medication complianceArkansas Children's Hospital Research InstituteUniversity of ArkansasRecruiting5 Years12 YearsAll60United States
63EUCTR2017-003737-29-GR
(EUCTR)
18/09/201903/09/2019Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis Active eosinophilic esophagitis and maintenance of remission in 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: Budesonide oral suspension [0.2 mg/ml]
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2;Phase 3Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom
64EUCTR2017-003737-29-GB
(EUCTR)
01/08/201924/10/2019Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis Active eosinophilic esophagitis and maintenance of remission in 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: Budesonide oral suspension [0.2 mg/ml]
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom
65EUCTR2018-000844-25-GB
(EUCTR)
12/07/201920/11/2018A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 3United States;Portugal;Spain;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
66EUCTR2018-000844-25-PT
(EUCTR)
08/07/201926/12/2018A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
425Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
67EUCTR2018-000844-25-NL
(EUCTR)
03/07/201911/12/2018A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
68EUCTR2018-000844-25-BE
(EUCTR)
14/06/201914/03/2019A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 3Canada;United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;Sweden
69EUCTR2017-003737-29-PT
(EUCTR)
24/05/201929/01/2019Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis Active eosinophilic esophagitis and maintenance of remission in 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: Budesonide oral suspension [0.2 mg/ml]
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2;Phase 3Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom
70EUCTR2017-003737-29-ES
(EUCTR)
11/04/201918/01/2019Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis Active eosinophilic esophagitis and maintenance of remission in 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: Budesonide oral suspension [0.2 mg/ml]
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom
71EUCTR2018-000844-25-ES
(EUCTR)
05/04/201917/05/2019A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
425Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
72NCT03656380
(ClinicalTrials.gov)
March 20, 201930/8/2018Mepo for EoE StudyA Multi-center, Randomized, Double Blind, Parallel-arm, Placebo Controlled Trial of Mepolizumab for Treatment of Adults and Adolescents With Active Eosinophilic Esophagitis and Dysphagia-predominant SymptomsEoE;Eosinophilic EsophagitisDrug: Mepolizumab 300 mg;Drug: Mepolizumab 100 mg;Other: PlaceboUniversity of North Carolina, Chapel HillGlaxoSmithKline;University of Utah;Northwestern University;MNGI Digestive Health, P.A.Recruiting16 Years75 YearsAll72Phase 2United States
73EUCTR2018-000844-25-FR
(EUCTR)
05/03/201914/11/2018A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
425 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
74EUCTR2018-000844-25-IT
(EUCTR)
05/02/201928/03/2019A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
425Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
75NCT03664960
(ClinicalTrials.gov)
November 14, 20186/9/2018An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic DuodenitisA Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Safety and Tolerability of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)Eosinophilic Gastritis;Eosinophilic Gastroenteritis;Eosinophilic DuodenitisDrug: AK002Allakos, Inc.NULLActive, not recruiting18 Years80 YearsAll58Phase 2United States
76NCT03781596
(ClinicalTrials.gov)
October 2, 201811/11/2018EoE RCT Fluticasone and Omeprazole vs Fluticasone AloneRandomized Controlled Trial Comparing Fluticasone Plus Omeprazole With Fluticasone Alone for Eosinophilic EsophagitisEosinophilic EsophagitisDiagnostic Test: Retrospective evaluation of endoscopy prior to study drug;Other: Symptom Survey;Other: Medication Compliance Phone Call;Diagnostic Test: Endoscopy while on study drug;Drug: Fluticasone;Drug: Omeprazole;Drug: Placebo oral capsuleClaire DanielsNULLRecruiting6 Years60 YearsAll100Phase 4United States
77NCT03633617
(ClinicalTrials.gov)
September 24, 201814/8/2018Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)Eosinophilic EsophagitisDrug: Dupilumab;Drug: PlaceboRegeneron PharmaceuticalsSanofiActive, not recruiting12 YearsN/AAll321Phase 3United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom
78NCT03496571
(ClinicalTrials.gov)
July 18, 20186/4/2018A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic GastroenteritisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic GastroenteritisEosinophilic Gastritis;Eosinophilic GastroenteritisDrug: AK002;Other: PlaceboAllakos, Inc.NULLCompleted18 Years80 YearsAll65Phase 2United States
79EUCTR2016-004749-10-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
80NCT04803162
(ClinicalTrials.gov)
November 14, 201714/3/2021The Role of HRM and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected EoEThe Role of High-resolution Esophageal Manometry and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected Eosinophilic EsophagitisEosinophilic EsophagitisDiagnostic Test: High-resolution manometry;Diagnostic Test: Serum biomarkers;Diagnostic Test: Gastrointestinal Quality of Life index;Drug: Omeprazole 20 MG Oral TabletWroclaw Medical UniversityNULLActive, not recruiting18 YearsN/AAll58Poland
81EUCTR2014-001485-99-DK
(EUCTR)
27/10/201706/07/2017Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in 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: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
204Phase 3Spain;Belgium;Denmark;Netherlands;United Kingdom;Switzerland
82EUCTR2016-004749-10-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
83NCT03245840
(ClinicalTrials.gov)
October 5, 20178/8/2017Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)A Phase 3, Multicenter, Open-label Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE)Eosinophilic Esophagitis (EoE)Drug: Budesonide oral suspensionShireTakeda Development Center Americas, Inc.Active, not recruiting11 Years55 YearsAll133Phase 3United States
84EUCTR2014-001485-99-IT
(EUCTR)
29/09/201720/01/2021Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo formaintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinicopathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in 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: Compressa effervescente 1 mg di budesonide per uso orodispersibile
Product Code: BUET 1 mg
INN or Proposed INN: BUDESONIDE
Product Name: Compressa effervescente 0,5 mg di budesonide per uso orodispersibile
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
DR. FALK PHARMA GMBHNULLNot RecruitingFemale: yes
Male: yes
204Phase 3Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Eswatini;Spain
85EUCTR2016-004749-10-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
86NCT03191864
(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
87NCT03290482
(ClinicalTrials.gov)
June 19, 201724/8/2017Natural History of Eosinophilic EsophagitisNatural History of Eosinophilic Esophagitis: A Longitudinal Follow-up Over 10 YearsEosinophilic EsophagitisDiagnostic Test: Barium Esophagram;Device: EsophaCap;Diagnostic Test: Physical Examination and QuestionnairesMayo ClinicNULLCompleted18 YearsN/AAll65United States
88NCT03029091
(ClinicalTrials.gov)
May 23, 201720/1/2017An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE)A Preliminary Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue DisorderEosinophilic EsophagitisDrug: Losartan PotassiumChildren's Hospital Medical Center, CincinnatiNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);National Institute of Allergy and Infectious Diseases (NIAID);Office of Rare Diseases (ORD);National Center for Advancing Translational Science (NCATS)Completed5 Years25 YearsAll15Phase 2United States
89EUCTR2014-001485-99-NL
(EUCTR)
24/08/201602/05/2016Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 19.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
204Phase 3Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Switzerland
90ChiCTR-DOD-16009003
2016-08-042016-08-10Perspective Study On Eosinophilic GastroenteritisPerspective Study On Eosinophilic Gastroenteritis Eosinophilic GastroenteritisGold Standard:;Index test:;Endoscopy Center, Department of Gastroenterology, The Third Affiliated Hospital of Sun Yat-sen University.NULLRecruitingBothTarget condition:0;Difficult condition:0China
91NCT04069429
(ClinicalTrials.gov)
July 201627/7/2019Radiation Dose in Humans From Orally Administered Tc99m-HeparinRadiation Dose in Humans From Orally Administered Tc99m-HeparinEosinophilic EsophagitisRadiation: Computerized Tomography scan;Radiation: Single Photon Emission Computed Tomography scans;Drug: Technetium Tc 99M;Radiation: Planar Images;Procedure: EsophagogastroduodenoscopyUniversity of UtahNULLCompleted18 Years70 YearsAll8Early Phase 1United States
92NCT02778867
(ClinicalTrials.gov)
May 20, 201612/10/2015SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet StudySix Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid TrialEosinophilic Gastrointestinal Disorders (EGIDs);Eosinophilic Esophagitis (EoE)Other: 1 Food Elimination Diet Therapy;Other: 6 Food Elimination Diet Therapy;Other: 6 Food Elimination Diet (after 1FED failure);Drug: Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)Children's Hospital Medical Center, CincinnatiNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);National Institute of Allergy and Infectious Diseases (NIAID);Office of Rare Diseases (ORD);National Center for Advancing Translational Science (NCATS)Completed18 Years60 YearsAll129Phase 2/Phase 3United States
93NCT02736409
(ClinicalTrials.gov)
April 29, 201622/3/2016An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE)Eosinophilic Esophagitis (EoE)Drug: Oral Budesonide Suspension (OBS);Drug: PlaceboShireNULLCompleted11 Years55 YearsAll200Phase 3United States;United Kingdom
94NCT02722148
(ClinicalTrials.gov)
April 21, 201624/3/2016Application of a Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy in Patients With Eosinophilic Esophagitis (IDiET)Application of a Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy in Patients With Eosinophilic Esophagitis (IDiET)Eosinophilic EsophagitisDevice: Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination TherapyUniversity of North Carolina, Chapel HillNational Institutes of Health (NIH)Completed16 Years80 YearsAll24N/AUnited States
95NCT02610816
(ClinicalTrials.gov)
March 21, 201612/10/2015Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed GlucocorticoidsEosinophilic Esophagitis (EoE) Intervention Trial-Randomized 1 Food Elimination vs. 4 Food Elimination Diet Followed by Swallowed GlucocorticoidsEosinophilic Esophagitis;Eosinophilic Gastrointestinal Disorders (EGIDs)Other: 1 Food Elimination Diet;Other: 4 Food Elimination Diet;Other: 4 Food Elimination Diet (post 1FED failure);Drug: Fluticasone Propionate, 800 mcg twice daily (post 4FED failure)Children's Hospital Medical Center, CincinnatiPatient-Centered Outcomes Research InstituteCompleted6 Years17 YearsAll67Phase 2/Phase 3United States
96JPRN-UMIN000021041
2016/02/1515/02/2016A study investigating the therapeutic effect of vonoprazan on the patients with proton pump inhibitor resistant eosinophilic esophagitisA study investigating the therapeutic effect of vonoprazan on the patients with proton pump inhibitor resistant eosinophilic esophagitis - A study investigating the therapeutic effect of vonoprazan on the patients with proton pump inhibitor resistant eosinophilic esophagitis Eosinophilic esophagitisadministration of Vonoprazan (20mg/day for 2 months)Second department of Internal Medicine, Shimane University Faculty of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female5Not selectedJapan
97EUCTR2014-001485-99-ES
(EUCTR)
22/01/201617/11/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 18.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
204Phase 3Spain;Switzerland
98EUCTR2014-001485-99-BE
(EUCTR)
22/01/201623/07/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in 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: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
204Phase 3Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland
99NCT02493335
(ClinicalTrials.gov)
January 15, 20167/7/2015Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic EsophagitisDouble-blind, Randomized, Placebo-controlled, Phase III Study on the Efficacy and Tolerability of a 48-week Treatment With Two Different Doses of Budesonide Effervescent Tablets vs. Placebo for Maintenance of Clinico-pathological Remission in Adult Patients With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Budesonide 0.5mg orodispersible tablet twice daily;Drug: Budesonide 1mg orodispersible tablet twice daily;Drug: Placebo orodispersible tablet twice dailyDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsAll204Phase 3Germany
100EUCTR2014-001484-12-NL
(EUCTR)
23/12/201512/10/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active substance), phase III study on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis - Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis Active eosinophilic esophagitis
MedDRA version: 18.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Spain;Belgium;Germany;Netherlands;Switzerland
101EUCTR2014-001485-99-GB
(EUCTR)
23/12/201523/10/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in 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: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
204Phase 3Belgium;Spain;Denmark;Netherlands;Germany;Switzerland;United Kingdom
102EUCTR2014-001485-99-DE
(EUCTR)
08/12/201529/06/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in 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: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
204Phase 3Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland
103NCT02605837
(ClinicalTrials.gov)
December 7, 20154/11/2015A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is AchievedOral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled StudyEosinophilic Esophagitis (EoE)Drug: Oral Budesonide Suspension (OBS);Drug: PlaceboShireNULLCompleted11 Years55 YearsAll318Phase 3United States
104NCT02434029
(ClinicalTrials.gov)
November 11, 201530/4/2015Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic EsophagitisDouble-blind, Randomized, Placebo-controlled, Phase III Trial on the Efficacy and Tolerability of a 6-week Treatment With Budesonide Effervescent Tablets vs. Placebo for Induction of Clinico-pathological Remission in Adult Patients With Active Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Budesonide 1mg orodispersible tablet twice daily;Drug: Placebo orodispersible tablet twice dailyDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsAll88Phase 3Germany
105EUCTR2014-001484-12-BE
(EUCTR)
09/10/201519/05/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active substance), phase III study on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis - Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis Active eosinophilic esophagitis
MedDRA version: 18.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Spain;Belgium;Netherlands;Germany;Switzerland
106NCT02579876
(ClinicalTrials.gov)
October 201514/10/2015Milk Patch for Eosinophilic EsophagitisA Double, Blind Placebo-controlled, Randomized Trial to Study Efficacy and Safety of the Viaskin Milk for Treating Milk Induced Eosinophilic Esophagitis in ChildrenEosinophilic Esophagitis;Milk AllergyDrug: Viaskin Milk 500 mcg;Drug: Viaskin PlaceboChildren's Hospital of PhiladelphiaDBV TechnologiesCompleted4 Years17 YearsAll20Phase 2United States
107EUCTR2014-001484-12-DE
(EUCTR)
22/09/201509/04/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active substance), phase III study on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis - Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis Active eosinophilic esophagitis
MedDRA version: 19.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Spain;Belgium;Netherlands;Germany;Switzerland
108EUCTR2014-001484-12-ES
(EUCTR)
18/08/201510/07/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active substance), phase III study on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis - Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis Active eosinophilic esophagitis
MedDRA version: 18.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Belgium;Spain;Netherlands;Germany;Switzerland
109NCT02379052
(ClinicalTrials.gov)
May 12, 201527/2/2015Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE)A Randomized, Double-Blind, Parallel, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Dupilumab in Adult Patients With Active Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Dupilumab;Drug: PlaceboRegeneron PharmaceuticalsSanofiCompleted18 Years65 YearsAll47Phase 2United States
110NCT02434705
(ClinicalTrials.gov)
April 201530/4/2015Food Antigen in Eosinophilic EsophagitisProtocol for Food Antigen Staining in Esophageal Mucosa in Patients With Eosinophilic EsophagitisEosinophilic EsophagitisOther: Antigen (wheat base soy sauce) sprayMayo ClinicNULLActive, not recruiting18 Years80 YearsAll20United States
111NCT02019758
(ClinicalTrials.gov)
January 1, 201518/12/2013Budesonide Versus Fluticasone for Treatment of Eosinophilic EsophagitisBudesonide Versus Fluticasone for Treatment of Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Oral Viscous Budesonide;Drug: Fluticasone MDI;Drug: Placebo slurry;Drug: Placebo inhalerUniversity of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed16 Years80 YearsAll129Phase 4United States
112NCT02353078
(ClinicalTrials.gov)
January 201526/1/2015The Effect of Sucralfate Slurry in Patients With Eosinophilic EsophagitisThe Effect of Sucralfate Slurry on Dilated Intercellular Spaces, Tight Junctions, Mucosal Impedance and Mucosal Activity in Patients With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Sucralfate;Procedure: Intraluminal Impedance;Device: Intraluminal ImpedanceMayo ClinicNULLCompleted18 Years80 YearsAll3Early Phase 1United States
113NCT02371941
(ClinicalTrials.gov)
December 201411/2/2015Oral Cromolyn Sodium for the Treatment of Eosinophilic EsophagitisA Randomized, Double-blind, Placebo-controlled Study of the Use of Oral Cromolyn Sodium for the Treatment of Eosinophilic EsophagitisEosinophilic EsophagitisDrug: oral cromolyn sodium;Drug: PlaceboUniversity of TennesseeNULLCompleted2 Years18 YearsAll16Phase 4United States
114NCT02314455
(ClinicalTrials.gov)
September 201410/11/2014Esophageal Absorption in EoEEsophageal Absorption in Eosinophilic EsophagitisEosinophilic EsophagitisOther: D-xyloseMayo ClinicNULLTerminated18 Years80 YearsBoth14N/AUnited States
115NCT02098473
(ClinicalTrials.gov)
August 31, 201425/3/2014Dose Ranging Study of RPC4046 in Eosinophilic EsophagitisA Phase2, Multi-Center, Multi-national, Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of RPC4046 in Adult Subjects With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: RPC4046;Drug: PlaceboCelgeneNULLCompleted18 Years65 YearsAll100Phase 2United States;Canada;Switzerland
116NCT02113267
(ClinicalTrials.gov)
April 201410/4/2014Mometasone-furoate for Treatment of Eosinophilic Esophagitis - a Randomized Placebo Controlled Study.Treatment of Eosinophilic Esophagitis With Mometason Furoat Aerosol: a Randomised, Placebo-controled Phase II Study for Evaluation of Treatment Effect on Group Level Including Symtom QuestionnairesEosinophilic EsophagitisDrug: Mometasone furoate;Drug: PlaceboMogens BoveVastra Gotaland RegionTerminated18 YearsN/AAll40Phase 2Sweden
117NCT02058537
(ClinicalTrials.gov)
February 20144/2/2014Bethanechol for Eosinophilic EsophagitisBethanechol for Treatment of Eosinophilic Esophagitis (EoE)Eosinophilic Esophagitis (EoE)Drug: BethanecholUniversity of IowaNULLTerminated18 Years75 YearsAll2Phase 2United States
118NCT02125851
(ClinicalTrials.gov)
January 201421/2/2014Comparison of Esophageal Clearance Times of Oral Budesonide PreparationsComparison of Esophageal Clearance Times of Oral Budesonide PreparationsEosinophilic EsophagitisOther: Xanthan Gum;Other: HoneyWalter Reed National Military Medical CenterNULLCompleted18 Years75 YearsBoth24N/AUnited States
119EUCTR2012-005842-39-SE
(EUCTR)
20/12/201305/11/2013Treatment of patients with eosinophilic esophagitis with mometason furoat aerosol: a randomised, placebo-controled phase II studyTreatment of eosinophilic esophagitis with mometason furoat aerosol: a randomised, placebo-controled phase II study for evaluation of treatment effect on group level including symtom questionnaires Eosinphilic Esophagitis;Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]Trade Name: NasonexNU-sjukvården, Norra Älvsborgs LänssjukhusNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSweden
120NCT01808196
(ClinicalTrials.gov)
October 10, 201330/1/2013Testing Effectiveness of Losartan in Patients With EoE With or Without a CTDA Preliminary, Open-label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder.Eosinophilic Esophagitis;Connective Tissue DisordersDrug: Losartan PotassiumChildren's Hospital Medical Center, CincinnatiNULLCompleted5 Years21 YearsAll6Phase 2United States
121NCT01929824
(ClinicalTrials.gov)
August 201314/8/2013Nasal Nitric Oxide Levels in Eosinophilic Esophagitis (EoE)A Pilot Study: Nasal Nitric Oxide Levels in Eosinophilic Esophagitis.Eosinophilic EsophagitisOther: Oral Nitric Oxide testingMayo ClinicNULLCompleted18 YearsN/AAll50United States
122NCT01821898
(ClinicalTrials.gov)
July 9, 201327/3/2013Eosinophilic Esophagitis Clinical Therapy Comparison TrialEosinophilic Esophagitis Clinical Therapy Comparison TrialEosinophilic EsophagitisDrug: Oral Budesonide;Other: Elimination dietBaylor College of MedicineNULLTerminated3 Years17 YearsAll5Phase 2United States
123NCT01814059
(ClinicalTrials.gov)
March 7, 201315/3/2013Sirolimus for Eosinophil-Associated Gastrointestinal DisordersA Phase 1, Open-Label Study of Sirolimus in Eosinophil-Associated Gastrointestinal DisordersEosinophilic Gastroenteritis;Eosinophilic EsophagitisDrug: sirolimusNational Institute of Allergy and Infectious Diseases (NIAID)NULLTerminated18 Years65 YearsAll4Phase 1United States
124NCT01865825
(ClinicalTrials.gov)
March 201323/5/2013Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)?PPI Responsive Esophageal Eosinophilia: GERD or Eosinophilic Esophagitis?Erosive EsophagitisRadiation: Esophageal Barium XrayMayo ClinicNULLCompleted18 YearsN/AAll20N/AUnited States
125NCT01846962
(ClinicalTrials.gov)
November 201230/4/2013Dietetic Versus Topical Steroids for Pediatric Eosinophilic EsophagitisCOMPARISON OF TREATMENT FOR PEDIATRIC EOSINOPHILIC ESOPHAGITIS: A RANDOMIZED CLINICAL TRIAL (DIETETIC Versus TOPICAL STEROIDS)Eosinophilic EsophagitisDrug: Budesonide;Drug: Fluticasone;Behavioral: six-foods elimination diet;Drug: Oral Viscous Budesonide (OVB)Azienda Policlinico Umberto INULLCompleted6 Months18 YearsAll64Phase 4Italy
126NCT01685034
(ClinicalTrials.gov)
October 20125/9/2012Allergy Immunotherapy in the Management of Eosinophilic EsophagitisEvaluation of the Clinical, Endoscopic and Histologic Effects of Environmental Allergy Immunotherapy in the Treatment of Eosinophilic EsophagitisEosinophilic EsophagitisBiological: Allergy immunotherapy (allergy shots)United States Naval Medical Center, San DiegoNULLWithdrawn18 YearsN/ABoth0N/ANULL
127NCT01642212
(ClinicalTrials.gov)
July 23, 201213/7/2012OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label ExtensionOral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label ExtensionEosinophilic Esophagitis (EoE)Drug: Oral Budesonide Suspension (MB-9);Drug: PlaceboShireNULLCompleted11 Years40 YearsAll93Phase 2United States
128NCT01479231
(ClinicalTrials.gov)
March 201222/11/2011Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic EsophagitisPredictors of PPI Response in Eosinophilic EsophagitisGastroesophageal Reflux Disease;Eosinophilic Esophagitis;DysphagiaDrug: dexlansoprazoleMayo ClinicNULLWithdrawn18 Years80 YearsBoth0Phase 1/Phase 2United States
129EUCTR2009-016692-29-BE
(EUCTR)
20/02/201224/11/2011A study to investigate the efficacy and tolerance of budesonide tablets and suspension in patients suffering from esophagitis over a 14 day periodDouble-blind, double-dummy, randomized, placebo-controlled, phase IIa study on the efficacy and tolerability of a 14-day treatment with budesonide effervescent tablets vs. viscous budesonide suspension vs. placebo in patients with eosinophilic esophagitis - Budesonide effervescent tablets vs. viscous budesonide suspension vs. placebo in EE Active eosinophilic esophagitis
MedDRA version: 14.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 2mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 2mg
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide [0.4mg/ml] viscous suspension
Product Code: BUU 0.4mg/ml
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Belgium;Germany;Switzerland
130NCT01702701
(ClinicalTrials.gov)
January 20124/10/2012Eosinophilic Esophagitis Treatment: Montelukast vs FluticasoneEosinophilic Esophagitis Treatment: Montelukast vs FluticasoneEosinophilic Esophagitis;DysphagiaDrug: Montelukast;Drug: FluticasoneMedical College of WisconsinNULLWithdrawn18 YearsN/AAll0Phase 3United States
131NCT01498497
(ClinicalTrials.gov)
January 201216/12/2011A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021Six Month Safety Follow-up Study for PR-021 [Multicenter, Randomized, Double-blind, Placebo-controlled, Safety and Tolerability Phase 1/2a Study of Two Dosing Regimens of EUR-1100 for Oral Use, in Eosinophilic Esophagitis Subjects]Eosinophilic EsophagitisDrug: EUR-1100;Drug: PlaceboForest LaboratoriesNULLCompleted12 Years55 YearsAll14Phase 1/2United States
132NCT01458418
(ClinicalTrials.gov)
December 201118/10/2011A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in ChildrenA Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in ChildrenEosinophilic EsophagitisDrug: Montelukast;Other: placebo;Drug: 5 mg MontelukastChildren's Mercy Hospital Kansas CityNULLTerminated2 Years17 YearsAll4N/AUnited States
133NCT01386112
(ClinicalTrials.gov)
September 201128/6/2011Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic EsophagitisA Multicenter, Randomized, Double-blind, Placebo-controlled, Safety and Tolerability Phase 1/2a Study of Two Dosing Regimens of EUR-1100 for Oral Use, in Subjects With Eosinophilic Esophagitis (EoE)Eosinophilic EsophagitisDrug: EUR-1100;Drug: placeboAptalis PharmaNULLCompleted12 Years55 YearsBoth24Phase 1/Phase 2United States
134NCT02280616
(ClinicalTrials.gov)
June 201129/10/2014Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Eosinophilic EsophagitisDouble-blind, Double-dummy, Randomized, Placebo-controlled, Phase IIa Study on the Efficacy and Tolerability of a 14-day Treatment With Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Patients With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: low dose budesonide tablet;Drug: high dose budesonide tablet;Drug: high dose budesonide suspension;Drug: PlaceboDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsBoth76Phase 2Germany
135NCT01624129
(ClinicalTrials.gov)
January 20118/2/2011New Serological Markers for Eosinophilic EsophagitisEosinophilic EsophagitisDrug: FluticasoneTechnische Universität MünchenNULLRecruiting18 Years80 YearsBoth20N/AGermany
136NCT01056783
(ClinicalTrials.gov)
August 201025/1/2010Proof of Concept Study of OC000459 in Eosinophilic EsophagitisA Randomized, Placebo-controlled, Double-blind, Single-centre Proof-of-concept Study of OC000459 in Adult Patients With Active Eosinophilic EsophagitisEosinophilic EsophagitisDrug: OC000459;Drug: PlaceboOxagen LtdNULLCompleted18 Years75 YearsBoth26Phase 2Switzerland
137NCT01170234
(ClinicalTrials.gov)
August 201023/7/2010Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic EsophagitisExhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic EsophagitisEosinophilic EsophagitisDevice: NIOX MINO® Airway Inflammation MonitorTufts Medical CenterNULLCompleted7 Years65 YearsAll14United States
138NCT01016223
(ClinicalTrials.gov)
March 201018/11/2009A Randomized Double Blind Placebo Controlled Study of the Effect of Swallowed Beclomethasone Dipropionate on Inflammatory Markers in Adult Patients With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Beclomethasone dipropionate;Drug: placeboPenn State UniversityNULLCompleted18 Years65 YearsBoth20Phase 1United States
139NCT02038894
(ClinicalTrials.gov)
December 20091/5/2013Comparing Anesthetic Techniques in Children Having EsophagogastroduodenoscopiesComparison Of Different Anesthetic Techniques In Children Undergoing EsophagogastroduodenoscopiesEosinophilic EsophagitisDrug: Intubated with Sevoflurane (IS);Drug: Intubated with Propofol (IP);Drug: Zofran - no intubation;Drug: PropofolChildren's Hospital Medical Center, CincinnatiNULLCompleted1 Year12 YearsAll179N/AUnited States
140NCT01022970
(ClinicalTrials.gov)
November 200925/11/2009Efficacy and Safety of QAX576 in Patients With Eosinophilic EsophagitisA Double Blinded Randomized Placebo-controlled Trial of Intravenous QAX576 in the Treatment of Eosinophilic Esophagitis (EoE)Eosinophilic EsophagitisDrug: QAX576 placebo;Drug: QAX576Novartis PharmaceuticalsNULLCompleted18 Years50 YearsAll25Phase 2United States
141NCT00961233
(ClinicalTrials.gov)
October 200914/8/2009Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis.Eosinophilic EsophagitisDrug: inhaled/swallowed budesonide;Drug: viscous/swallowed budesonideUniversity of North Carolina, Chapel HillAstraZenecaCompleted18 YearsN/AAll25N/AUnited States
142NCT01040598
(ClinicalTrials.gov)
June 200927/12/2009Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease ModelIdentifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease ModelEosinophilic EsophagitisBiological: OmalizumabO & O Alpan LLCGenentech, Inc.Completed12 Years76 YearsBoth19Phase 1United States
143NCT00762073
(ClinicalTrials.gov)
January 8, 200929/9/2008Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic EsophagitisOral Viscous Budesonide Suspension (MB-7) in Subjects With Eosinophilic Esophagitis: A Randomized, Placebo-Controlled, Dose-Ranging Study in Children and AdolescentsEosinophilic Esophagitis (EoE)Drug: budesonide;Drug: placeboShireNULLCompleted2 Years18 YearsAll82Phase 2United States
144NCT00880906
(ClinicalTrials.gov)
August 200825/8/2008Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic EsophagitisProspective, Single-Blinded, Randomized Controlled Trial With Sham Comparing Standard Therapy With or Without Esophageal Dilatation in Patients With Eosinophilic EsophagitisSuspected Eosinophilic EsophagitisProcedure: Esophageal dilation;Drug: Steroid and Proton Pump Inhibitor TherapyVanderbilt UniversityTakedaCompleted18 Years75 YearsAll50N/AUnited States
145NCT00635089
(ClinicalTrials.gov)
July 20086/3/2008Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic EsophagitisAn Open-Label Safety and Efficacy Study of Reslizumab (CTx55700) for the Treatment of Pediatric Subjects With Eosinophilic Esophagitis Who Completed Study Res-5-0002Eosinophilic EsophagitisDrug: reslizumabCeption TherapeuticsCephalonCompleted5 YearsN/AAll190Phase 3United States;Canada
146NCT00728481
(ClinicalTrials.gov)
May 200815/7/2008The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic EsophagitisThe Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic EsophagitisEosinophilic Esophagitis;Gastroesophageal Reflux Disease;EE;GERDDrug: Esomeprazole;Drug: BudesonideMayo ClinicAstraZenecaCompleted18 Years80 YearsAll51Phase 2/Phase 3United States
147NCT00895817
(ClinicalTrials.gov)
April 20086/5/2009Fluticasone Versus Esomeprazole to Treat Eosinophilic EsophagitisComparison of Aerosolized Swallowed Fluticasone to Esomeprazole for the Treatment of Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Swallowed fluticasone;Drug: EsomeprazoleWalter Reed Army Medical CenterNULLCompleted18 YearsN/AAll42N/AUnited States
148NCT00538434
(ClinicalTrials.gov)
March 20081/10/2007Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 YearsAn Efficacy and Safety Study of Reslizumab (CTx55700) in the Treatment of Eosinophilic Esophagitis in Subjects Aged 5 to 18 YearsEosinophilic EsophagitisBiological: Reslizumab;Other: SalineCeption TherapeuticsNULLCompleted5 Years18 YearsAll227Phase 2/Phase 3United States;Canada
149NCT00638456
(ClinicalTrials.gov)
February 200812/3/2008Use of Topical Budesonide in the Treatment of Eosinophilic EsophagitisUse of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical TrialEosinophilic EsophagitisDrug: Budesonide plus Prevacid;Drug: placebo plus PrevacidRanjan DohilMeritage Pharma, Inc.Completed1 YearN/AAll32Phase 2United States
150NCT01404832
(ClinicalTrials.gov)
October 200727/7/2011The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump InhibitorsThe Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump InhibitorsGastroesophageal Reflux Disease;Eosinophilic EsophagitisDrug: Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptomsDallas VA Medical CenterTAP Pharmaceutical Products Inc.Terminated18 YearsN/AAll102Phase 4United States
151NCT00523354
(ClinicalTrials.gov)
August 200730/8/2007Off Label Use of Infliximab in Adult Patients With Severe Eosinophilic EsophagitisPhase 2 Proof-of-Concept Study to Analyze the Efficacy of in TNF-Alpha Blockade in Adult Patients With Severe, Corticosteroid-Dependent Eosinophilic EsophagitisEsophagitisDrug: InfliximabSwiss EE Study GroupNULLCompleted18 Years70 YearsBothPhase 2Switzerland
152NCT00511316
(ClinicalTrials.gov)
August 20071/8/2007Trial of Montelukast in Eosinophilic EsophagitisA Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Montelukast/ Singulair;Drug: PlaceboMayo ClinicMerck Sharp & Dohme Corp.;Merck Sharp & Dohme Corp.Completed18 Years100 YearsBoth41Phase 1United States
153NCT00426283
(ClinicalTrials.gov)
January 200722/1/2007A Study of Flovent in Patients With Eosinophilic EsophagitisA Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Flovent;Other: PlaceboMarc Rothenberg, MDNULLCompleted3 Years30 YearsAll42Phase 2United States
154NCT00358449
(ClinicalTrials.gov)
September 11, 200627/7/2006Intravenous Mepolizumab In Children With Eosinophilic EsophagitisA Randomized, Double-blind, Parallel Group Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Mepolizumab (SB240563)(0.55mg/kg, 2.5mg/kg or 10mg/kg) in Pediatric Subjects With Eosinophilic Esophagitis, Aged 2 to 17 Years (Study MEE103219)Oesophagitis, EosinophilicDrug: mepolizumabGlaxoSmithKlineNULLCompleted2 Years17 YearsAll84Phase 2United States;Australia;Canada;United Kingdom
155EUCTR2005-006074-10-GB
(EUCTR)
15/06/200607/02/2006A randomized, double-blind, parallel group clinical trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab (SB240563) (0.55mg/kg, 2.5mg/kg or 10mg/kg) in pediatric subjects with eosinophilic esophagitis, aged 2 to 17 years - Mepolizumab in paediatric eosinophilic oesophagitisA randomized, double-blind, parallel group clinical trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab (SB240563) (0.55mg/kg, 2.5mg/kg or 10mg/kg) in pediatric subjects with eosinophilic esophagitis, aged 2 to 17 years - Mepolizumab in paediatric eosinophilic oesophagitis Eosinophilic oesophagitisProduct Name: Mepolizumab
Product Code: SB-240563
INN or Proposed INN: Mepolizumab
GlaxoSmithKline Research & Development Ltd.NULLNot Recruiting Female: yes
Male: yes
72 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
156NCT00271349
(ClinicalTrials.gov)
December 200529/12/2005Budesonide for Eosinophilic EsophagitisBudesonide for Eosinophilic Esophagitis: a Randomized, Placebo-controlled, Double-blind Treatment StudyEosinophilic EsophagitisDrug: BudesonideSwiss EE Study GroupNULLCompleted14 Years70 YearsBoth28Phase 2Switzerland
157NCT00123630
(ClinicalTrials.gov)
November 200521/7/2005A Pilot Study of the Treatment of Eosinophilic Esophagitis With OmalizumabA Pilot Study of the Treatment of Eosinophilic Esophagitis With OmalizumabEsophagitisDrug: omalizumab;Drug: PlaceboUniversity of UtahNovartis PharmaceuticalsCompleted12 Years60 YearsAll30Phase 2United States
158NCT00275561
(ClinicalTrials.gov)
November 200510/1/2006Topical Steroid Treatment for Eosinophilic EsophagitisA Randomized Placebo-controlled Trial of Swallowed Fluticasone in Treatment of Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Fluticasone;Drug: PlaceboMayo ClinicNULLCompleted18 Years60 YearsAll42Phase 2United States
159NCT00148603
(ClinicalTrials.gov)
September 20056/9/2005Montelukast in the Treatment of Duodenal EosinophiliaMontelukast in the Treatment of Duodenal Eosinophilia in Children With Dyspepsia: Effect on Eosinophil Density and Activation in Relation to PharmacokineticsEosinophilic Gastroenteritis;DyspepsiaDrug: montelukastChildren's Mercy Hospital Kansas CityMerck Sharp & Dohme Corp.Completed8 Years17 YearsBoth24N/AUnited States
160NCT00123656
(ClinicalTrials.gov)
August 200421/7/2005Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic EsophagitisComparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic EsophagitisEsophagitisDrug: esomeprazole;Drug: fluticasoneUniversity of UtahAmerican Society for Gastrointestinal EndoscopyCompleted18 Years80 YearsBoth30Phase 2United States
161NCT00084097
(ClinicalTrials.gov)
June 2, 20045/6/2004Omalizumab to Treat Eosinophilic GastroenteritisPilot Study of Omalizumab in Eosinophilic GastroenteritisGastroenteritisDrug: OmalizumabNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted12 Years76 YearsAll30Phase 2United States
162NCT00266578
(ClinicalTrials.gov)
October 200215/12/2005A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic DisordersEffect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled TrialEosinophilic EsophagitisDrug: Fluticasone PropionateMarc RothenbergNULLCompleted3 Years30 YearsBoth30Phase 3United States
163NCT00266565
(ClinicalTrials.gov)
December 200115/12/2005Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic SyndromeA Phase I/II Study of the Effect of Intravenous Anti-IL-5 (Mepolizumab) SB 240563 on the Outcome and Management of Hypereosinophilic SyndromesHypereosinophilic Syndromes;Eosinophilic Gastroenteritis;Churg-Strauss Syndrome;Eosinophilic EsophagitisDrug: MepolizumabChildren's Hospital Medical Center, CincinnatiNULLCompleted18 Years65 YearsAll24Phase 1/Phase 2United States
164NCT00017862
(ClinicalTrials.gov)
June 200115/6/2001Anti-Interleukin-5 Antibody to Treat Hypereosinophilic SyndromeA Pilot Phase II Study of the Efficacy of Humanized Anti-IL5 Antibody (SCH55700) in Reducing Eosinophilia in Patients With Hypereosinophilic Syndrome or Eosinophilic Gastroenteritis Refractory to or Intolerant of Conventional TherapyHypereosinophilic SyndromeDrug: SCH55700National Institute of Allergy and Infectious Diseases (NIAID)NULLCompletedN/AN/ABoth10Phase 2United States
165EUCTR2019-002871-32-PL
(EUCTR)
15/01/2020A Study of Benralizumab in Patients with Eosinophilic EsophagitisA Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify
Product Name: benralizumab
Product Code: MEDI-563
INN or Proposed INN: benralizumab
Other descriptive name: benralizumab
AstraZeneca ABNULLNAFemale: yes
Male: yes
170Phase 3France;United States;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy;Japan
166EUCTR2014-002465-30-IT
(EUCTR)
24/06/2014Spontaneous study on the efficacy and safety of an oral viscous suspension of budesonide administered to children affected by eosinophilic esophagitis.Spontaneous study on the efficacy and safety of an oral viscous suspension of budesonide administered to children affected by eosinophilic esophagitis. Eosinophilic Esophagitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Budesonide
Product Code: Budesonide
INN or Proposed INN: BUDESONIDE
Dip. Pediatria UOC Gastroenterologia ed Epatologia PediatricaNULLNAFemale: yes
Male: yes
Phase 2Italy
167EUCTR2020-004336-16-AT
(EUCTR)
22/03/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLNAFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand
168EUCTR2020-004335-24-BE
(EUCTR)
24/12/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLNAFemale: yes
Male: yes
259Phase 3Portugal;Spain;Austria;Israel;United Kingdom;Italy;United States;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
169EUCTR2017-003737-29-DE
(EUCTR)
17/12/2018Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis Active eosinophilic esophagitis and maintenance of remission in 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: Budesonide oral suspension [0.2 mg/ml]
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom
170EUCTR2020-004335-24-AT
(EUCTR)
18/11/2021A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLNAFemale: yes
Male: yes
259Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan
171EUCTR2020-004336-16-BE
(EUCTR)
07/05/2021A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitisA Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis EOSINOPHILIC ESOPHAGITIS
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Cendakimab
Product Code: CC-93538
INN or Proposed INN: Cendakimab
Celgene International II SàrlNULLNAFemale: yes
Male: yes
399Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand