A Trial Evaluating EP-104IAR in Adults With Eosinophilic Esophagitis
Eosinophilic Esophagitis
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis
Eligibility Criteria
Inclusion Criteria: Symptomatic EoE; For women of childbearing potential, a negative pregnancy test and willing to use a highly effective method of birth control until end of study; Willing and able to adhere to study-related procedures and visit schedule; Willing and able to provide informed consent. Exclusion Criteria: Concomitant esophageal disease, relevant GI disease, or any condition, history, or laboratory abnormality that might interfere with the study; Oral or esophageal mucosal infection of any type (bacterial, viral, or fungal); Oropharyngeal or dental conditions that prevents normal eating; Severe esophageal motility disorders other than EoE; Contraindication to or factors that substantially increase risks associated with EGD or biopsy, or narrowing of the esophagus that precludes EGD with a standard 9-10 mm endoscope, stricture requiring dilation within 8 weeks prior to Screening, or the need for dilation prior to EGD at Baseline; Any condition for which the use of corticosteroids is contraindicated (Participants with well controlled non-insulin dependent diabetes are permitted); Active or quiescent systemic fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. Or recent use of IV or oral antibiotics; Hypersensitivity, or intolerance to corticosteroids, or to any of the ingredients in the investigational medicinal product; Recent use of disallowed medications, or unwillingness to not use disallowed medications during the study; Recent initiation of a elimination or elemental diet (dietary therapy must remain stable throughout the study); Morning serum cortisol level ≤ 5 μg/dL (138 nmol/L); Clinically significant abnormal laboratory values; Recent or currently planned participation in another interventional trial ; Previous participation in this study and had received study treatment; Females who are pregnant, breastfeeding, or planning to become pregnant during the study; Malignancies or history of malignancy within prior 5 years, except for treated or excised non-metastatic BCC, SCC of the skin, or cervical carcinoma in situ; History of alcohol or drug abuse; Any other reason, that, in the Investigator's opinion, unfavorably alters participant risk, confounds results, or prevents the participant from complying with study requirements.
Sites / Locations
- Princess Alexandra HospitalRecruiting
- Royal Adelaide HospitalRecruiting
- G.I. Research InstituteRecruiting
- Amsterdam UMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
EP-104IAR 4 mg
EP-104IAR 8 mg
EP-104IAR 12 mg
EP-104IAR 16 mg
EP-104IAR 10 mg
EP-104IAR 20 mg
EP-104IAR 30 mg
EP-104IAR 40 mg
4 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
8 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
16 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
4 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
8 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
16 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.