DDrare: Database of Drug Development for Rare Diseases

Searched query = "Eosinophilic gastrointestinal disease", "Eosinophilic gastroenteritis", "Eosinophilic esophagitis", "Eosinophilic colitis", "Eosinophilic gastro-intestinal disorder", "EGID", "Neonatal food-protein induced enterocolitis", "N-FPIES"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0.5 mg budesonide effervescent tablet for orodispersible use; 1 mg budesonide effervescent tablet for orodispersible use; 1mg budesonide effervescent tablet for orodispersible use; 2mg budesonide effervescent tablet for orodispersible use; 5 mg Montelukast; AK002; APT-1011; APT-1011 - 3 mg; Allergen; Allergy immunotherapy (allergy shots); Antolimab; BUDESONIDE; BUET 0.5 mg; BUET 1mg; BUET 2mg; BUU 0.4mg/ml; Barium; Beclomethasone dipropionate; Behavioral: six-foods elimination diet; Benralizumab; Bethanechol; Budesonide; Budesonide 0.5mg orodispersible tablet twice daily; Budesonide 1mg orodispersible tablet twice daily; Budesonide [0.4mg/ml] viscous suspension; Budesonide oral suspension; Budesonide oral suspension [0.2 mg/ml]; Budesonide plus Prevacid; CALY-002; Cromolyn; DUPILUMAB; Device: EsophaCap; Device: Intraluminal Impedance; Device: NIOX MINO® Airway Inflammation Monitor; Device: Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy; Dexlansoprazole; Diagnostic Test: Barium Esophagram; Diagnostic Test: Bone Mineral Density (DEXA) scan; Diagnostic Test: Endoscopy while on study drug; Diagnostic Test: Height measurement; Diagnostic Test: Physical Examination and Questionnaires; Diagnostic Test: Retrospective evaluation of endoscopy prior to study drug; Diagnostic Test: Vitamin D Measurement; Dupilumab; Dupilumab (blinded); Dupilumab (open-label); Dupixent; ESO-101; EUR-1100; Esomeprazole; FLUTICASONE PROPIONATE; Famotidine; Florence 30 µg/mL; Florence 60 µg/mL; Florence 90 µg/mL; Flovent; Fluticasone; Fluticasone MDI; Fluticasone Propionate; Fluticasone Propionate, 800 mcg twice daily (post 4FED failure); Fluticasone Propionate, 880 mcg twice daily (after 6FED failure); Fluticasone Propionate, USP; Fluticasone propionate; Gold; High dose budesonide suspension; High dose budesonide tablet; Honey; Infliximab; Inhaled/swallowed budesonide; Intubated with Propofol (IP); Intubated with Sevoflurane (IS); Lansoprazole; Lirentelimab; Lirentelimab (AK002); Loratadine; Losartan; Losartan Potassium; Low dose budesonide tablet; MEDI-563; MOMETASONE FUROATE; MONITOR; Mepolizumab; Mepolizumab 100 mg; Mepolizumab 300 mg; Milk; Mometasone; Mometasone furoate; Montelukast; Montelukast/ Singulair; Nasonex; Nitric Oxide; OC000459; Omalizumab; Omeprazole; Omeprazole 20mg BID; Oral Budesonide; Oral Budesonide Suspension (MB-9); Oral Budesonide Suspension (OBS); Oral Viscous Budesonide; Oral Viscous Budesonide (OVB); Oral cromolyn sodium; Other: 1 Food Elimination Diet; Other: 1 Food Elimination Diet Therapy; Other: 4 Food Elimination Diet; Other: 4 Food Elimination Diet (post 1FED failure); Other: 6 Food Elimination Diet (after 1FED failure); Other: 6 Food Elimination Diet Therapy; Other: Antigen (wheat base soy sauce) spray; Other: Assessment of medication compliance; Other: D-xylose; Other: Elimination diet; Other: Honey; Other: Medication Compliance Phone Call; Other: Oral Nitric Oxide testing; Other: Saline; Other: Symptom Survey; Other: Xanthan Gum; Potassium; Procedure: Esophageal dilation; Procedure: Esophagogastroduodenoscopy; Procedure: Intraluminal Impedance; Propofol; QAX576; RPC4046; Radiation: Computerized Tomography scan; Radiation: Esophageal Barium Xray; Radiation: Planar Images; Radiation: Single Photon Emission Computed Tomography scans; Reslizumab; SB-240563; SCH55700; Sevoflurane; Sirolimus; Steroid and Proton Pump Inhibitor Therapy; Sucralfate; Swallowed fluticasone; Technetium Tc 99M; Technetium Tc 99m; Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms; Viaskin Milk 500 mcg; Viscous/swallowed budesonide; Vitamin D; Vonoprazan; Wheat; Xanthan gum; Xylose; Zofran - no intubation

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04620811 (ClinicalTrials.gov)	December 3, 2020	3/11/2020	An 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 Duodenitis	Drug: lirentelimab	Allakos, Inc.	NULL	Enrolling by invitation	18 Years	80 Years	All	170	Phase 3	United States
2	EUCTR2019-004391-19-NL (EUCTR)	30/07/2020	13/05/2020	Study to Evaluate the Efficacy and Safety of AK002 in Patients with Active Eosinophilic Esophagitis	A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safetyof AK002 in Adult and Adolescent Patients with Active Eosinophilic Esophagitis	Active Eosinophilic Esophagitis (EoE) MedDRA version: 20.0;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Antolimab Product Code: AK002 INN or Proposed INN: Antolimab	Allakos Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Phase 2;Phase 3	United States;Australia;Netherlands
3	NCT04322708 (ClinicalTrials.gov)	July 6, 2020	24/3/2020	A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis	A 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 Esophagitis	Eosinophilic Esophagitis	Other: Placebo;Drug: lirentelimab (AK002)	Allakos, Inc.	NULL	Recruiting	12 Years	80 Years	All	300	Phase 2;Phase 3	United States;Australia;Netherlands
4	NCT04322604 (ClinicalTrials.gov)	June 18, 2020	24/3/2020	A 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 Duodenitis	Drug: lirentelimab (AK002);Other: Placebo	Allakos, Inc.	NULL	Recruiting	18 Years	80 Years	All	160	Phase 3	United States
5	NCT03664960 (ClinicalTrials.gov)	November 14, 2018	6/9/2018	An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis	A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Safety and Tolerability of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis	Eosinophilic Gastritis;Eosinophilic Gastroenteritis	Drug: AK002	Allakos, Inc.	NULL	Active, not recruiting	18 Years	80 Years	All	58	Phase 2	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT03496571 (ClinicalTrials.gov)	July 18, 2018	6/4/2018	A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis	A 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 Gastroenteritis	Eosinophilic Gastritis;Eosinophilic Gastroenteritis	Drug: AK002;Other: Placebo	Allakos, Inc.	NULL	Completed	18 Years	80 Years	All	65	Phase 2	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04620811
(ClinicalTrials.gov)

December 3, 2020

3/11/2020

An 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 Duodenitis

Drug: lirentelimab

Allakos, Inc.

NULL

Enrolling by invitation

18 Years

80 Years

All

170

Phase 3

United States

EUCTR2019-004391-19-NL
(EUCTR)

30/07/2020

13/05/2020

Study to Evaluate the Efficacy and Safety of AK002 in Patients with Active Eosinophilic Esophagitis

A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safetyof AK002 in Adult and Adolescent Patients with Active Eosinophilic Esophagitis

Active Eosinophilic Esophagitis (EoE)
MedDRA version: 20.0;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Antolimab
Product Code: AK002
INN or Proposed INN: Antolimab

Allakos Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Phase 2;Phase 3

United States;Australia;Netherlands

NCT04322708
(ClinicalTrials.gov)

July 6, 2020

24/3/2020

A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis

A 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 Esophagitis

Eosinophilic Esophagitis

Other: Placebo;Drug: lirentelimab (AK002)

Allakos, Inc.

NULL

Recruiting

12 Years

80 Years

All

300

Phase 2;Phase 3

United States;Australia;Netherlands

NCT04322604
(ClinicalTrials.gov)

June 18, 2020

24/3/2020

A 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 Duodenitis

Drug: lirentelimab (AK002);Other: Placebo

Allakos, Inc.

NULL

Recruiting

18 Years

80 Years

All

160

Phase 3

United States

NCT03664960
(ClinicalTrials.gov)

November 14, 2018

6/9/2018

An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Safety and Tolerability of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

Eosinophilic Gastritis;Eosinophilic Gastroenteritis

Drug: AK002

Allakos, Inc.

NULL

Active, not recruiting

18 Years

80 Years

All

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03496571
(ClinicalTrials.gov)

July 18, 2018

6/4/2018

A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

A 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 Gastroenteritis

Eosinophilic Gastritis;Eosinophilic Gastroenteritis

Drug: AK002;Other: Placebo

Allakos, Inc.

NULL

Completed

18 Years

80 Years

All

Phase 2

United States