A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)

Sanofi

Status and phase: Active, not recruiting; Phase 4

Conditions: Eosinophilic Oesophagitis

Treatments: Drug: Placebo; Drug: Dupilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06101095

U1111-1280-5266 (Registry Identifier)

2022-502491-23 (Registry Identifier)

LPS17558

Details and patient eligibility

About

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).

Full description

The duration per participant will be up to 152 weeks.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

• Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome).
• Active Helicobacter pylori infection.
• History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery.
• 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.
• History of bleeding disorders or esophageal varices.
• Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline.
• Initiation or change of a food elimination diet regimen or reintroduction of a previously eliminated food group in the 6 weeks prior to screening.
• Participation in prior dupilumab clinical study or participants currently treated or have been treated with commercially available dupilumab or contraindicated to dupilumab per local labelling.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 2 patient groups, including a placebo group

Dupilumab

Experimental group

Description:

Subcutaneous injection (SC) as per protocol

Treatment:

Drug: Dupilumab

Placebo

Placebo Comparator group

Description:

SC injection as per protocol

Treatment:

Drug: Placebo