A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)

Phase 1

• Conditions: Eosinophilic Esophagitis (EoE); MedDRA version: 20.1Level: PTClassification code 10064212Term: Eosinophilic oesophagitisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-000844-25-DE
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-13
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

1. A documented diagnosis of EoE by endoscopic biopsy prior to screening
2. Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration
3. History (by patient report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening.

Are the trial subjects under 18? yes
Number of subjects for this age range: 82
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 198
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Key Exclusion Criteria (Parts A & B):
1. Body weight =40 kg
2. Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
3. Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening.
4. Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
5. Active Helicobacter pylori infection
6. History of achalasia, Crohn’s disease, ulcerative colitis, celiac disease, and prior esophageal surgery
7. Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening
8. History of bleeding disorders or esophageal varices
9. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Key Exclusion Criteria (Part C):
1. Participants who, during the double-blind treatment period (Part A or Part B), developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to study drug, which in the opinion of the investigator could indicate that continued treatment with study drug may present an unreasonable risk for the participant.
2. Participants who became pregnant during the double-blind treatment period
3. Participants who are prematurely discontinued from study drug due to an AE (patients who are prematurely discontinued from study drug due to lack of efficacy are eligible to enter Part C)
4. Patients who did not undergo endoscopy with biopsies prior to receiving rescue treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified