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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)
NCT06101095 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06101095
The ClinicalTrials.gov registry entry for NCT06101095 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06101095 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Illinois, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06101095?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06101095?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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