A Phase 4, Randomized, Multicenter, Double-blind, Parallel-group, 24 Weeks, Placebo-controlled Study Followed by 104 Weeks Open-label to Assess Dupilumab Efficacy on Esophageal Function and Remodeling in Adult Participants With Eosinophilic Esophagitis (EoE)

Status: Active_not_recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis. Duration of study period (per participant) * Screening period: Up to 12 weeks before Week 0 * Randomized double-blind period: 24 weeks * Open label period: 104 weeks * Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first. There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A documented diagnosis of EoE by endoscopic biopsy.

• Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration.

• History (by participant report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening.

• Body weight ≥40 kg.

Locations
United States
California
United Gastroenterologists - Murrieta- Site Number : 8400001
Murrieta
University of California San Francisco - Parnassus Heights- Site Number : 8400020
San Francisco
Florida
Borland Groover Clinic- Site Number : 8400016
Jacksonville
Iowa
University of Iowa- Site Number : 8400006
Iowa City
Idaho
Treasure Valley Medical Research- Site Number : 8400018
Boise
Illinois
Northwestern University- Site Number : 8400003
Chicago
GI Alliance - Glenview- Site Number : 8400012
Glenview
Illinois Gastroenterology Group- Site Number : 8400004
Gurnee
Massachusetts
University of Massachusetts Chan Medical School- Site Number : 8400019
Worcester
Minnesota
Mayo Clinic Hospital Rochester- Site Number : 8400008
Rochester
North Carolina
University of North Carolina at Chapel Hill- Site Number : 8400007
Chapel Hill
Ohio
Cleveland Clinic - Cleveland- Site Number : 8400009
Cleveland
Pennsylvania
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400010
Philadelphia
Texas
Private Practice - Dr. Martin Yudovich- Site Number : 8400015
Houston
GI Alliance - Mansfield- Site Number : 8400017
Mansfield
Other Locations
Brazil
Clínica Loema - Unidade I- Site Number : 0760007
Campinas
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006
Porto Alegre
Itaigara Memorial - Hospital Dia- Site Number : 0760005
Salvador
Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760003
São Paulo
Clinica de Alergia Martti Antila- Site Number : 0760001
Sorocaba
Canada
Investigational Site Number : 1240002
Montreal
Investigational Site Number : 1240004
Vancouver
Investigational Site Number : 1240006
Vancouver
Israel
Investigational Site Number : 3760002
Haifa
Investigational Site Number : 3760006
Haifa
Investigational Site Number : 3760004
Jerusalem
Investigational Site Number : 3760005
Jerusalem
Investigational Site Number : 3760003
Tel Aviv
Switzerland
Investigational Site Number : 7560001
Wetzikon
Investigational Site Number : 7560002
Zurich
Time Frame
Start Date: 2023-11-29
Completion Date: 2028-02-01
Participants
Target number of participants: 64
Treatments
Experimental: Dupilumab
Subcutaneous injection (SC) as per protocol
Placebo_comparator: Placebo
SC injection as per protocol
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: Sanofi

This content was sourced from clinicaltrials.gov