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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)