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L'essai clinique NCT06101095 pour Eosinophilic Oesophagitis est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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SanofiA 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)
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L'essai clinique NCT06101095 est conçu pour étudier le treatment de Eosinophilic Oesophagitis. Il s'agit d'un essai interventionnel en Phase IV. Son statut actuel est : actif, pas en recrutement. L'essai a débuté le 29 novembre 2023 et vise à recruter 64 participants. Dirigé par Sanofi, l'essai devrait être terminé d'ici le 1 février 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 18 juin 2025.
Résumé succinct
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).
Description détaillée
The duration per participant will be up to 152 weeks.
Titre officiel
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)
Conditions
Eosinophilic OesophagitisPublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'essai
- LPS17558
- U1111-1280-5266 (Identifiant de registre) (ICTRP)
- 2022-502491-23 (Identifiant de registre) (CTIS)
Numéro NCT
Date de début (réel)
2023-11-29
Dernière mise à jour publiée
2025-06-18
Date de fin (estimée)
2028-02-01
Inscription (estimée)
64
Type d'essai
Interventionnel
PHASE
Phase IV
Statut
Actif, pas en recrutement
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Triple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalDupilumab Subcutaneous injection (SC) as per protocol | Dupilumab Subcutaneous injection (SC) as per protocol |
Comparateur placeboPlacebo SC injection as per protocol | PLACEBO SC injection as per protocol |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe (EndoFLIP) | 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. | From baseline to Week 24 |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Percent change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe | 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. | From baseline up to Week 24 |
Absolute change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe | 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. | From baseline up to Week128 |
Percent change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe | 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. | From Baseline up to Week 128 |
Change from baseline in eosinophilic esophagitis-endoscopic reference score (EoE-EREFS) | EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease. | From baseline up to Week 128 |
Change from baseline in eosinophilic esophagitis (EoE-HSS) Grade | Severity (grade) and extent (stage) of esophageal abnormalities are scored using a 4-point scale (0 normal; 3 maximum change). Higher score indicates greater severity and extent of histological abnormalities. | From Baseline up to Week 128 |
Change from baseline in EoE-HSS Stage | Severity (grade) and extent (stage) of esophageal abnormalities are scored using a 4-point scale (0 normal; 3 maximum change). Higher score indicates greater severity and extent of histological abnormalities. | From Baseline up to Week 128 |
Proportion of participants who achieved peak Esophageal Intraepithelial Eosinophil Count of ≤6 eosinophils/high power field (Eos/HPF) | Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). | At Weeks 24, 76 and 128 |
Proportion of participants who achieved peak Esophageal Intraepithelial Eosinophil Count of ≤15 Eos/HPF | Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). | At Weeks 24, 76 and 128 |
Change from baseline in normalized enrichment score (NES) for EoE diagnostic panel (EDP) transcriptome signature | NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease). | From baseline up to Week 128 (EOT) |
Change from baseline in normalized enrichment score (NES) for type 2 inflammation transcriptome signature | NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease). | From Baseline up to Week 128 (EOT) |
Incidence of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs) | From the first IMP administration up to end of post treatment follow up period (week139) | |
Incidence of adverse events of special interest (AESIs) | From the first IMP administration up to end of post treatment follow up period (week139) |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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.
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
Regeneron Pharmaceuticals211 essais cliniques actifs à explorerAucune donnée de contact disponible
30 Centres de l'essai dans 5 pays
Investigational Site Number : 7560001, Wetzikon, 8620, Switzerland
Investigational Site Number : 7560002, Zurich, 8091, Switzerland
British Columbia
Investigational Site Number : 1240006, Vancouver, British Columbia, V5Z 1M9, Canada
Investigational Site Number : 1240004, Vancouver, British Columbia, V6Z 2K5, Canada
Quebec
Investigational Site Number : 1240002, Montreal, Quebec, H4A 3T2, Canada
California
United Gastroenterologists - Murrieta- Site Number : 8400001, Murrieta, California, 92563, United States
University of California San Francisco - Parnassus Heights- Site Number : 8400020, San Francisco, California, 94143, United States
Florida
Borland Groover Clinic- Site Number : 8400016, Jacksonville, Florida, 32256, United States
Idaho
Treasure Valley Medical Research- Site Number : 8400018, Boise, Idaho, 83706, United States
Illinois
Northwestern University- Site Number : 8400003, Chicago, Illinois, 60611, United States
GI Alliance - Glenview- Site Number : 8400012, Glenview, Illinois, 60026, United States
Illinois Gastroenterology Group- Site Number : 8400004, Gurnee, Illinois, 60031, United States
Iowa
University of Iowa- Site Number : 8400006, Iowa City, Iowa, 52242, United States
Massachusetts
University of Massachusetts Chan Medical School- Site Number : 8400019, Worcester, Massachusetts, 01655, United States
Minnesota
Mayo Clinic Hospital Rochester- Site Number : 8400008, Rochester, Minnesota, 55905, United States
North Carolina
University of North Carolina at Chapel Hill- Site Number : 8400007, Chapel Hill, North Carolina, 27514, United States
Ohio
Cleveland Clinic - Cleveland- Site Number : 8400009, Cleveland, Ohio, 44195, United States
Pennsylvania
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400010, Philadelphia, Pennsylvania, 19104, United States
Texas
Private Practice - Dr. Martin Yudovich- Site Number : 8400015, Houston, Texas, 77087, United States
GI Alliance - Mansfield- Site Number : 8400017, Mansfield, Texas, 76063, United States
Estado de Bahia
Itaigara Memorial - Hospital Dia- Site Number : 0760005, Salvador, Estado de Bahia, 41825-010, Brazil
Rio Grande do Sul
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006, Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
São Paulo
Clínica Loema - Unidade I- Site Number : 0760007, Campinas, São Paulo, 13010-001, Brazil
Clinica de Alergia Martti Antila- Site Number : 0760001, Sorocaba, São Paulo, 18040-425, Brazil
Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760003, São Paulo, 01323-020, Brazil
Investigational Site Number : 3760006, Haifa, 3104802, Israel
Investigational Site Number : 3760002, Haifa, 3109601, Israel
Investigational Site Number : 3760005, Jerusalem, 9103102, Israel
Investigational Site Number : 3760004, Jerusalem, 9112001, Israel
Investigational Site Number : 3760003, Tel Aviv, 6423906, Israel