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Department of Medicine

Eosinophilic Esophagitis (EoE) Research Studies

Eosinophilic Esophagitis (EoE) research studies currently enrolling new participants

A multi-center, randomized, double blind, parallel-arm, placebo controlled trial of mepolizumab for treatment of adults and adolescents with active eosinophilic esophagitis and dysphagia-predominant symptoms (Mepo for EoE Study)

Purpose: To determine whether mepolizumab is more effective than placebo for improving symptoms of dysphagia and decreasing esophageal eosinophil counts in adults and adolescents with active eosinophilic esophagitis after an initial 3 month treatment course, and will also assess the impact of an additional 3 months of treatment.

Principal Investigators: Evan Dellon, MD MPH
Sponsor: GlaxoSmithKline

Visit ClinicalTrials.gov to learn more about this study: Mepo for EoE

Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR)

Interested participants can join the contact registry through the Rare Diseases Clinical Research Network. Please follow the link: RareDiseasesNetwork.org

Purpose: To learn about eosinophilic gastrointestinal disorders (EGIDs) and support individuals with the disorders by building a network of patients, researchers, and health care professionals.
Principal Investigators: Evan Dellon, MD MPH at UNC. Marc Rothenberg, MD, PhD at Cincinnati Children’s Hospital
Sponsor: Cincinnati Children’s Hospital

Risk Factors and Biomarkers for Diagnosis and Treatment of EoE

Currently enrolling by invitation only

Purpose: To learn about eosinophilic esophagitis (EoE) and find a better and less invasive way other than endoscopy to diagnose EoE.
Principal Investigator: Evan Dellon, MD MPH
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Visit ClinicalTrials.gov to learn more about this study: Risk Factors and Biomarkers for Diagnosis and Treatment of EoE

UNC Eosinophilic Esophagitis (EoE) Patient Registry

Currently enrolling by invitation only

Purpose: To learn about eosinophilic esophagitis (EoE) in children, adolescents, and adults.
Principal Investigator: Evan Dellon, MD MPH
Sponsor: University of North Carolina at Chapel Hill

A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) with Eosinophilic Esophagitis (EoE) – SHP621-302

Currently enrolling by invitation only

Purpose: To evaluate the long term safety and effectiveness of oral budesonide suspension (OBS)
Principal Investigator: Evan Dellon, MD MPH
Sponsor: Shire

Visit clinicaltrials.gov to learn more about this Study of Long-Term OBS in Adolescent and Adult Subjects

A Phase 3, Multicenter, Open-label Continuation Study with Budesonide Oral Suspension (OBS) for Adolescent and Adult Subjects with Eosinophilic Esophagitis (EoE) – SHP621-303

Currently enrolling by invitation only

Purpose: To evaluate the long term safety and effectiveness of oral budesonide suspension (OBS)
Principal Investigator: Evan Dellon, MD MPH
Sponsor: Shire

Visit clinicaltrials.gov to learn more about this Study of Long-Term OBS in Adolescent and Adult Subjects

A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) (R66-EE-1774)

Currently enrolling

Purpose: To determine the treatment effect of dupilumab compared with placebo
Principal Investigator: Evan Dellon, MD MPH
Sponsor: Regeneron Pharmaceuticals, Inc.

Visit clinicaltrials.gov to learn more about this R668-EE-1774

 

Please contact us for more information regarding any of the above active CEDAS research studies

Closed to Enrollment

FLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomize, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis

Closed to enrollment

Purpose: To evaluate the efficacy (histological response) of APT-1011 in adults with eosinophilic esophagitis (EoE)
Principal Investigator: Evan Dellon, MD MPH
Sponsor: Adare Pharmaceuticals

Visit clinicaltrials.gov to learn more about this FLUTE Study

Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) with Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study – SHP621-301

Currently enrolling

Purpose: To evaluate the the safety and effectiveness of oral budesonide suspension (OBS)
Principal Investigator: Evan Dellon, MD MPH
Sponsor: Shire

Visit clinicaltrials.gov to learn more about this Study of OBS in Adolescent and Adult Subjects

iDiet: Application of a Novel Allergen-Specific Immune Signature-Directed approach to Dietary Elimination Therapy in Patients with EoE

Enrollment closed

Purpose: To see if a new way to test for food allergies can help people with Eosinophilic Esophagitis (EoE) learn if certain foods make the disease worse.
Principal Investigator: Evan Dellon, MD MPH
Sponsor: UNC Team Translational Science Award

Visit ClinicalTrials.gov to learn more about this study:iDiet study

Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis (EoE) – TREET Trial

Enrollment closed

Purpose: To determine whether oral viscous budesonide (OVB) or fluticasone metered dose inhaler (MDI) most effectively treats EoE by improving histologic findings and symptoms, which medication provides a more durable treatment response, and whether biomarkers can predict treatment response.
Principal Investigator: Evan Dellon, MD MPH
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Visit ClinicalTrials.gov to learn more about this study: Budesonide Versus Fluticasone for Treatment of EoE

Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis – RPC02-201

Enrollment closed

Purpose: To test RPC4046, an investigational drug in development by Receptos, Inc. for the potential treatment of Eosinophilic Esophagitis (EoE).
Principal Investigator: Evan Dellon, MD MPH
Sponsor: Receptos, Inc.

Visit ClinicalTrials.gov to learn more about this study: Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

Diagnosis and Monitoring of Eosinophilic Esophagitis Using the Cytosponge

Enrollment closed

Purpose: To assess the safety, acceptability, and accuracy of Cytosponge for diagnosis and monitoring of Eosinophilic Esophagitis (EoE) in comparison to endoscopy with biopsy as the gold standard.
Principal Investigator: Evan Dellon, MD MPH
Sponsor and Collaborators: C.U.R.E.D. Foundation, Mayo Clinic, University of Cambridge

Visit clinicaltrials.gov to learn more about this study: Diagnosis and Monitoring of EoE Using Cytosponge

A Randomized, Double-Blind, Parallel, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Dupilumab in Adult Patients with Active Eosinophilic Esophagitis (EoE) – R668-EE-1324

Enrollment closed

Purpose: To evaluate the the safety and effectiveness of dupilumab
Principal Investigator: Evan Dellon, MD MPH
Sponsor: Regeneron Pharmaceuticals Inc

Visit clinicaltrials.gov to learn more about this Study of Dupilumab in Adult Patients With Active Eosinophilic Esophagitis (EoE)

Please contact us for more information regarding any of the above active CEDAS research studies: