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A Trial to Evaluate EP 104GI in Adults with Eosinophilic Esophagitis (EoE) (RESOLVE)
EU CTIS ID: 2024-516689-13-00
What this study is testing
Phase 1b: To determine the safety, tolerability, and RP2D(s) and regimen(s) of EP 104GI Phase 1b: To determine the pharmacokinetic (PK) profile of EP 104GI Phase 2: To evaluate the efficacy of EP 104GI on the severity and extent of Eosinophilic Esophagitis (EoE) disease measured by the EoE Histology Scoring System (EoEHSS)
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults 18 to 75 years of age, inclusive
- Symptomatic EoE defined as: a. Phase 1b, dose escalation portion: SDI score ≥ 5 at screening and baseline; Phase 2, randomized portion: SDI score ≥ 5 at screening and DSQ total score ≥ 10 over a 14 day period during screening (at least 11 of 14 days must be completed) b. Confirmed historical diagnosis of EoE with PEC > 15/hpf
- For women of childbearing potential, a negative pregnancy test (at baseline) and willing to use a highly effective method of birth control for at least 4 weeks before Day 0, and for at least 52 weeks following the dose of study drug (Day 0 or Week 24)
- 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 (Phase 2, randomized dose optimization portion): 1. Has completed the Phase 2, randomized dose optimization portion of the trial to Week 24, inclusive 2. Without safety concerns for receiving EP 104GI (i.e., does not meet exclusion criteria or have other safety issue)
You likely can't join if
- Any concomitant esophageal disease and relevant GI disease including but not limited to eosinophilic gastritis or enteritis (defined by clinicopathologic features), erosive esophagitis Los Angeles grade C or higher, Barrett’s esophagus, previous esophageal surgery, Celiac disease, inflammatory bowel disease, or any condition or history of illness or laboratory abnormality that in the investigator’s judgment might interfere with study procedures or ability to complete the study. Note: Participants with occasional gastroesophageal reflux disease (GERD) symptoms without severe (Los Angeles grade C or higher) endoscopic erosive reflux esophagitis are permitted
- 10. Use of a new inhaled or intranasal corticosteroid within 60 days prior to dosing, or a change in dose of an inhaled or intranasal corticosteroid within 60 days of dosing (a temporary dose change lasting ≤ 14 days is permitted)
- 11. Initiation of an elimination diet or elemental diet within 30 days prior to dosing (dietary therapy must remain stable throughout the study)
- Use of biologic immunomodulators in the 90 days prior to dosing
- Use of immunosuppressive drugs, or potent cytochrome P450 3A4 inhibitors in the 90 days prior to dosing
- Initiated, discontinued, or changed dosage regimen of PPIs for any condition such as GERD or allergic rhinitis within 4 weeks prior to dosing. Doses must remain stable throughout the study
See the full eligibility criteria
Who can join
- Adults 18 to 75 years of age, inclusive
- Symptomatic EoE defined as: a. Phase 1b, dose escalation portion: SDI score ≥ 5 at screening and baseline; Phase 2, randomized portion: SDI score ≥ 5 at screening and DSQ total score ≥ 10 over a 14 day period during screening (at least 11 of 14 days must be completed) b. Confirmed historical diagnosis of EoE with PEC > 15/hpf
- For women of childbearing potential, a negative pregnancy test (at baseline) and willing to use a highly effective method of birth control for at least 4 weeks before Day 0, and for at least 52 weeks following the dose of study drug (Day 0 or Week 24)
- 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 (Phase 2, randomized dose optimization portion): 1. Has completed the Phase 2, randomized dose optimization portion of the trial to Week 24, inclusive 2. Without safety concerns for receiving EP 104GI (i.e., does not meet exclusion criteria or have other safety issue)
- Criteria for participation in the Extended PK Substudy: 1. Willing and able to provide informed consent for the Extended PK Substudy. 2. Has not used any products containing FP within 7 days prior to the PK visit. 3. Had detectable plasma FP (above the lower limit of quantitation) at their previous PK visit.
What rules you out
- Any concomitant esophageal disease and relevant GI disease including but not limited to eosinophilic gastritis or enteritis (defined by clinicopathologic features), erosive esophagitis Los Angeles grade C or higher, Barrett’s esophagus, previous esophageal surgery, Celiac disease, inflammatory bowel disease, or any condition or history of illness or laboratory abnormality that in the investigator’s judgment might interfere with study procedures or ability to complete the study. Note: Participants with occasional gastroesophageal reflux disease (GERD) symptoms without severe (Los Angeles grade C or higher) endoscopic erosive reflux esophagitis are permitted
- 10. Use of a new inhaled or intranasal corticosteroid within 60 days prior to dosing, or a change in dose of an inhaled or intranasal corticosteroid within 60 days of dosing (a temporary dose change lasting ≤ 14 days is permitted)
- 11. Initiation of an elimination diet or elemental diet within 30 days prior to dosing (dietary therapy must remain stable throughout the study)
- Use of biologic immunomodulators in the 90 days prior to dosing
- Use of immunosuppressive drugs, or potent cytochrome P450 3A4 inhibitors in the 90 days prior to dosing
- Initiated, discontinued, or changed dosage regimen of PPIs for any condition such as GERD or allergic rhinitis within 4 weeks prior to dosing. Doses must remain stable throughout the study
- Morning serum cortisol level ≤ 5 μg/dL (138 nmol/L) at Screening visit
- Use of another investigational product within the 30 days prior to dosing, or an investigational biologic within 90 days prior to dosing, or current/planned participation in another interventional trial during this study
- Previous participation in this study and had received study treatment
- Female participants who are pregnant, breastfeeding, or planning to become pregnant within 52 weeks postdose
- The following laboratory values at screening: a. Elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3× upper limit of normal (ULN), bilirubin, alkaline phosphatase (ALP), and/or creatinine > 1.5× ULN b. Elevated prothrombin time or international normalized ratio > 1.5× ULN c. Hemoglobin A1c (HbA1c) value of ≥ 8.0% (64 mmol/mol) (Note: individuals with insulin dependence or non insulin dependent poorly controlled diabetes will be excluded)
- Presence of oral or esophageal mucosal infection of any type (bacterial, viral, or fungal)
- Malignancies or history of malignancy within 5 years of screening, except for adequately treated or completely excised nonmetastatic basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ
- History of patient reported alcohol or drug abuse within 6 months prior to screening
- Unwillingness to withhold protocol prohibited medications during the trial
- Any other reason, including a severe acute or chronic medical or psychiatric condition(s) or laboratory abnormality, that, in the opinion of the investigator, is likely to unfavorably alter participant risk benefit, confound study results, or make it difficult for the participant to fully comply with study requirements
- Any oropharyngeal or dental condition that prevents normal eating
- Known severe esophageal motility disorders other than EoE
- Contraindication to or factors that substantially increase the risk associated with EGD or esophageal biopsy, or narrowing of the esophagus that precludes EGD with a standard 9 10 mm endoscope, stricture requiring dilation within the 8 weeks prior to Screening, or the need for dilation prior to EGD at baseline
- A history or presence of any condition for which the use of corticosteroids is contraindicated (e.g., insulin dependent diabetes mellitus, Cushing’s syndrome, Addison’s disease, cortisol related endocrinopathy, etc.) Note: Participants with well controlled non insulin dependent diabetes are permitted.
- Known active or quiescent systemic fungal, bacterial (including tuberculosis), viral (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV]), or parasitic infections, or ocular herpes simplex. Or any infection requiring intravenous [IV] antibiotics within 4 weeks of baseline, or oral antibiotics within 2 weeks of baseline
- Known hypersensitivity, or intolerance to corticosteroids, or to any of the ingredients in the investigational medicinal product (IMP), including carboxymethyl cellulose, and polysorbate 80, or to the ingredients in Synacthen / cosyntropin (used in the ACTH stimulation test)
- Use of systemic corticosteroids and any use of FP within 60 days prior to dosing, or swallowed topical corticosteroids within 60 days prior to dosing, or extended use of high potency dermal topical corticosteroids within 60 days prior to dosing
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United Kingdom
- Switzerland
- New Zealand
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United Kingdom; Switzerland; New Zealand; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.