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Department of Medicine

Eosinophilic Esophagitis (EoE) Research Studies

Eosinophilic Esophagitis (EoE) research studies currently enrolling new participants

BUL8/ EEA: 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

Purpose: 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.

Principal Investigators: Evan Dellon, MD MPH
Phase: III
Sponsor: Dr. Falk Pharma GmbH
UNC Study Link: UNC Research For Me 
Interested? Send us an email
ClinicalTrials.gov ID: NCT06596252

Visit ClinicalTrials.gov to learn more about this study: BUL-8/EEA

EDESIA: A US Registry of Eosinophilic Esophagitis Patients Treated With Dupixent as Standard of Care (R668-EE-2328)

Purpose: 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

Principal Investigators: Evan Dellon, MD MPH
Phase: IV (Observational)
Sponsor: Regeneron
UNC Study Link: UNC Research For Me 
Interested? Send us an email
ClinicalTrials.gov ID: NCT06693531

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

EoE-201: 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

Purpose: 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.

Principal Investigators: Evan Dellon, MD MPH
Phase: II
Sponsor: Phathom Pharmaceuticals, Inc.
UNC Study Link: UNC Research For Me 
Interested? Send us an email
ClinicalTrials.gov ID: NCT06693531

Visit ClinicalTrials.gov to learn more about this study: EoE-201

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

 

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

Ariel Sanderford

Ariel_Sanderford@med.unc.edu

Send me an Email!

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: