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NCT06101095 · ClinicalTrials.gov registry record · Phase 4
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)
A Phase 4 study of Eosinophilic Oesophagitis, sponsored by Sanofi.
- Active
- Registry status
- Phase 4
- Development phase
- 69
- Enrollment target
- 20
- Study locations
NCT06101095: Active Phase 4 study of Eosinophilic Oesophagitis, sponsored by Sanofi.
NCT06101095 is a Phase 4 study of Eosinophilic Oesophagitis that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 69 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06101095, a Phase 4 study of Eosinophilic Oesophagitis, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 69 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Distensibility plateau provides an assessment of esophageal function. An increase in distensibility plateau indicates an improvement in esophageal function and a decrease in distensibility plateau indicates a worsening of esophageal function.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dupilumab
Study Locations (20)
Illinois
- Northwestern University- Site Number : 8400003 - Chicago
- GI Alliance - Glenview- Site Number : 8400012 - Glenview
- Illinois Gastroenterology Group- Site Number : 8400004 - Gurnee
California
- United Gastroenterologists - Murrieta- Site Number : 8400001 - Murrieta
- University of California San Francisco - Parnassus Heights- Site Number : 8400020 - San Francisco
Texas
- Private Practice - Dr. Martin Yudovich- Site Number : 8400015 - Houston
- GI Alliance - Mansfield- Site Number : 8400017 - Mansfield
São Paulo
- Clínica Loema - Unidade I- Site Number : 0760007 - Campinas
- Clinica de Alergia Martti Antila- Site Number : 0760001 - Sorocaba
Florida
- Borland Groover Clinic- Site Number : 8400016 - Jacksonville
Idaho
- Treasure Valley Medical Research- Site Number : 8400018 - Boise
Iowa
- University of Iowa- Site Number : 8400006 - Iowa City
Massachusetts
- University of Massachusetts Chan Medical School- Site Number : 8400019 - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2023-11-29 |
| Est. Completion | 2028-02-01 |
| Phase | Phase 4 |
What the registry record for NCT06101095 still lists
NCT06101095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Eosinophilic Oesophagitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06101095 names 20 study sites across 15 states, led by Illinois, California, Texas.
Frequently Asked Questions
What is clinical trial NCT06101095 about?
NCT06101095 is a clinical study titled "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)". 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 funct...
What is the current status of trial NCT06101095?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 69 participants. The study started on 2023-11-29. Estimated completion is 2028-02-01.
What conditions does trial NCT06101095 study?
This clinical trial studies the following conditions: Eosinophilic Oesophagitis.
What interventions are being tested in trial NCT06101095?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG).
Who is sponsoring clinical trial NCT06101095?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06101095 being conducted?
This trial has 20 study locations across California, Florida, Idaho, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06101095's enrollment target sits among peer trials
69 1070th of 2000 higher than 926 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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