NCT05608681 A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).
| NCT ID | NCT05608681 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Eupraxia Pharmaceuticals Inc. |
| Condition | Eosinophilic Esophagitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 117 participants |
| Start Date | 2023-03-31 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 117 participants in total. It began in 2023-03-31 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase 1b/2 study to explore the safety, efficacy and pharmacokinetics of EP-104GI in adults with eosinophilic esophagitis (EoE). Endoscopic and histologic assessments will also be evaluated to understand the local effects of EP-104GI on eosinophilic EoE disease activity. Approximately 27 to 33 participants will be enrolled in dose escalation: 3-6 participants per dose cohort. The number of participants enrolled in escalation will depend on the number of dose escalation cohorts evaluated, and dose cohorts needing to be expanded. An additional 10-24 participants will be enrolled in 1 or 2 cohorts of 10-12 participants each at tolerable dose regimen(s) selected based on the accumulated clinical data to identify the recommended phase 2 dose(s) (RP2D). In the Phase 2 randomized dose optimization portion of the study, approximately 120 subjects will be randomized to Dose A (120 mg total dose), Dose B (160 mg total dose), or matching vehicle control, with an overall assignment ratio of 1:1:1. The total number of participants in both portions of the study will be approximately 160. The study involves 8-10 site visits spread over approximately 52 weeks. Participants in an extended PK sub study will have up to 4 additional visits, to a maximum of 108 weeks post-dose. The participants will either receive the active study drug (EP-104GI) or matching vehicle control. Matching vehicle control will be used only in randomized dose optimization portion of the study. Participants randomized to receive vehicle control may receive EP-104GI (Dose A or Dose B) following the completion of Week 24 providing they meet eligibility criteria for crossover to EP-104GI. Participants randomized to receive EP-104GI on Day 0 will not receive EP-104GI or vehicle control at Week 24. The study drug or matching vehicle control will be administered by qualified personnel during an esophagogastroduodenoscopy (EGD) procedure at the Baseline/Dosing visit. Safety will be assessed throughout the study. Blood and urine samples will be collected at site visits for laboratory assessments and to measure plasma levels of EP-104GI. Participants will complete questionnaires to assess symptoms of dysphagia and odynophagia and will undergo 3-5 EGDs with esophageal biopsies at the Baseline, Week 4 (dose escalation phase only), Week 12, Week 24 (randomized dose optimization phase only), Week 26, and Week 52 (randomized dose optimization phase only).
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. 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.
Contact & Investigator
Mark Kowalski, MD PhD
STUDY DIRECTOR
Eupraxia Pharmaceuticals
Frequently Asked Questions
Who can join the NCT05608681 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Eosinophilic Esophagitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05608681 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05608681 currently recruiting?
Yes, NCT05608681 is actively recruiting participants. Contact the research team at pravikumar@eupraxiapharma.com for enrollment information.
Where is the NCT05608681 trial being conducted?
This trial is being conducted at Sydney, Australia, Brisbane, Australia, Brisbane, Australia, Maroochydore, Australia and 11 additional locations.
Who is sponsoring the NCT05608681 clinical trial?
NCT05608681 is sponsored by Eupraxia Pharmaceuticals Inc.. The principal investigator is Mark Kowalski, MD PhD at Eupraxia Pharmaceuticals. The trial plans to enroll 117 participants.