{"id":2259,"date":"2014-01-15T16:25:00","date_gmt":"2014-01-15T21:25:00","guid":{"rendered":"https:\/\/med.sites.unc.edu\/cedas\/research-1\/current-eoe-research-studies\/"},"modified":"2025-12-09T16:03:11","modified_gmt":"2025-12-09T21:03:11","slug":"current-eoe-research-studies","status":"publish","type":"page","link":"https:\/\/www.med.unc.edu\/cedas\/research-1\/current-eoe-research-studies\/","title":{"rendered":"Eosinophilic Esophagitis (EoE) Research Studies"},"content":{"rendered":"

Eosinophilic Esophagitis (EoE) research studies currently enrolling new participants<\/h1>\n\n\n\n\n\n\n
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BUL8\/ EEA:<\/strong> Double-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis<\/h2>\n

Purpose:<\/strong> The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tablets for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.<\/p>\n

Principal Investigators:<\/strong> Evan Dellon, MD MPH
\nPhase: <\/strong>III<\/div>\n
Sponsor:<\/strong> Dr. Falk Pharma GmbH
\n<\/span><\/span><\/span><\/div>\n

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EDESIA:<\/strong> A US Registry of Eosinophilic Esophagitis Patients Treated With Dupixent as Standard of Care (R668-EE-2328)<\/h2>\n

Purpose:<\/strong> To collect data on the characteristics, treatment patterns, and outcomes among patients with EoE with initiated treatment with Dupixient in routine clinical practice in the US. To generate longer-term real-world safety data of Dupixient in EoE patients<\/p>\n

Principal Investigators:<\/strong> Evan Dellon, MD MPH
\nPhase: <\/strong>IV (Observational)<\/div>\n
Sponsor:<\/strong> Regeneron
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EoE-201:<\/strong> A Phase 2, Randomized, Double-Blind, Multi-Center, 3-Part Study in Adult and Adolescent Subjects with Eosinophilic Esophagitis (EoE) to Evaluate the Safety and Efficacy of Vonoprazan 10 mg and 20 mg Compared to Placebo After 12 Weeks and to Evaluate the Safety and Efficacy of Vonoprazan 10 mg and 20 mg Up to 52 Weeks<\/h2>\n

Purpose:<\/strong> The primary objective of this study is to assess the efficacy of vonoprazan 20 mg once daily (QD) compared to placebo QD in the number of participants with a peak eosinophilic histologic response <15 eosinophils per high-power field (eos\/hpf) after 12 weeks of therapy.<\/p>\n

Principal Investigators:<\/strong> Evan Dellon, MD MPH
\nPhase: <\/strong>II<\/div>\n
Sponsor:<\/strong> Phathom Pharmaceuticals, Inc.
\n<\/span><\/span><\/span><\/div>\n

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Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR)<\/h2>\n

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Interested participants can join the contact registry through the Rare Diseases Clinical Research Network. Please follow the link: RareDiseasesNetwork.org<\/a><\/p>\n

Purpose: <\/strong>To learn about eosinophilic gastrointestinal disorders (EGIDs) and support individuals with the disorders by building a network of patients, researchers, and health care professionals.
\nPrincipal Investigators<\/strong>: Evan Dellon, MD MPH at UNC. Marc Rothenberg, MD, PhD at Cincinnati Children’s Hospital
\nSponsor:<\/strong> Cincinnati Children’s Hospital<\/div>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
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Please contact us for more information regarding any of the above active CEDAS research studies<\/span><\/h3>\n

Ariel Sanderford<\/strong><\/p>\n

Ariel_Sanderford@med.unc.edu<\/p>\n

Send me an Email!<\/a><\/p>\n

Closed to Enrollment<\/span><\/span><\/h1>\n
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FLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomize, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis<\/h2>\n

Closed to enrollment<\/p>\n

Purpose:<\/strong> To evaluate the efficacy (histological response) of APT-1011 in adults with eosinophilic esophagitis (EoE)
\nPrincipal Investigator:<\/strong> Evan Dellon, MD MPH
\nSponsor:<\/strong> Adare Pharmaceuticals
\n<\/span><\/div>\n

Visit clinicaltrials.gov to learn more about this FLUTE Study<\/span><\/a><\/p>\n

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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
\n<\/span><\/h2>\n

Currently enrolling<\/p>\n

Purpose: <\/strong>To evaluate the the safety and effectiveness of oral budesonide suspension (OBS)
\nPrincipal Investigator:<\/strong> Evan Dellon, MD MPH
\n<\/strong>Sponsor: <\/strong>Shire<\/span><\/div>\n

Visit clinicaltrials.gov to learn more about this Study of OBS in Adolescent and Adult Subjects<\/span><\/span><\/a><\/p>\n

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iDiet: Application of a Novel Allergen-Specific Immune Signature-Directed approach to Dietary Elimination Therapy in Patients with EoE<\/h2>\n

Enrollment closed<\/p>\n

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.
\nPrincipal Investigator: Evan Dellon, MD MPH
\nSponsor: UNC Team Translational Science Award<\/div>\n

Visit ClinicalTrials.gov to learn more about this study:iDiet study<\/a><\/p>\n

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Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis (EoE) – TREET Trial<\/h2>\n

Enrollment closed<\/p>\n

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.
\nPrincipal Investigator: Evan Dellon, MD MPH
\nSponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)<\/div>\n

Visit ClinicalTrials.gov to learn more about this study: Budesonide Versus Fluticasone for Treatment of EoE<\/a><\/p>\n

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Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis – RPC02-201<\/h2>\n

Enrollment closed<\/p>\n

Purpose: To test RPC4046, an investigational drug in development by Receptos, Inc. for the potential treatment of Eosinophilic Esophagitis (EoE).
\nPrincipal Investigator: Evan Dellon, MD MPH
\nSponsor: Receptos, Inc.<\/div>\n

Visit ClinicalTrials.gov to learn more about this study: Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis<\/a><\/span><\/p>\n

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Diagnosis and Monitoring of Eosinophilic Esophagitis Using the Cytosponge<\/h2>\n

Enrollment closed<\/p>\n

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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.
\nPrincipal Investigator: Evan Dellon, MD MPH
\nSponsor and Collaborators: C.U.R.E.D. Foundation, Mayo Clinic, University of Cambridge<\/div>\n

Visit clinicaltrials.gov to learn more about this study: Diagnosis and Monitoring of EoE Using Cytosponge<\/a><\/p>\n

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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<\/h2>\n

Enrollment closed<\/p>\n

Purpose: To evaluate the the safety and effectiveness of dupilumab
\nPrincipal Investigator: Evan Dellon, MD MPH
\nSponsor: Regeneron Pharmaceuticals Inc<\/span><\/div>\n

Visit clinicaltrials.gov to learn more about this Study of Dupilumab<\/span> in Adult Patients With Active Eosinophilic Esophagitis (EoE<\/span>)<\/a><\/p>\n

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Please contact us for more information regarding any of the above active CEDAS research studies:<\/p>\n