Phase 2 study for people with Gastro-oesophageal Reflux Disease

Reproduced exactly, unedited. Written for researchers rather than for patients.

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.

Criteria for crossover to EP 104GI from vehicle control (randomized dose optimization portion):

1. Has completed the randomized dose optimization portion of the trial to Week 24, inclusive
2. Without safety concerns for receiving EP 104GI ie, does not meet exclusion criteria or have other safety issue

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, including carboxymethyl cellulose, and polysorbate 80, or to the ingredients in Synacthen / cosyntropin (used in the ACTH stimulation test);
• 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.