A Trial to Evaluate EP-104IAR in Adults With Eosinophilic Esophagitis (EoE). (RESOLVE)

Eupraxia Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Eosinophilic Esophagitis

Treatments: Drug: EP-104IAR

Study type: Interventional

Funder types: Industry

Identifiers

NCT05608681

EP-104IAR-102 (RESOLVE)

Details and patient eligibility

About

An open-label, dose-escalation study to explore the safety, tolerability and pharmacokinetics of EP-104IAR in adults with eosinophilic esophagitis (EoE). Endoscopic and histologic assessments will also be evaluated to understand the local effects of EP-104IAR on eosinophilic EoE disease activity.

Approximately 27 to 33 participants will be enrolled in dose escalation: 3-6 participants per dose cohort in approximately 9 cohorts. 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).

The study involves 8-10 site visits spread over approximately 24-52 weeks.

All participants will receive active study drug (EP-104IAR), The study drug 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-104IAR.

Participants will complete questionnaires to assess symptoms of dysphagia and odynophagia and will undergo 3-4 EGDs with esophageal biopsies at the Baseline/Dosing Visit, at 4, 12 and 36 weeks post dose.

Enrollment: 57 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 9 patient groups

EP-104IAR 4 mg

Experimental group

Description:

4 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Treatment:

Drug: EP-104IAR

EP-104IAR 8 mg

Experimental group

Description:

8 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Treatment:

Drug: EP-104IAR

EP-104IAR 20 mg

Experimental group

Description:

8 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Treatment:

Drug: EP-104IAR

EP-104IAR 30 mg

Experimental group

Description:

12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Treatment:

Drug: EP-104IAR

EP-104IAR 48 mg

Experimental group

Description:

12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Treatment:

Drug: EP-104IAR

EP-104IAR 64 mg

Experimental group

Description:

16 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Treatment:

Drug: EP-104IAR

EP-104IAR 72 mg

Experimental group

Description:

12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Treatment:

Drug: EP-104IAR

EP-104IAR 96 mg

Experimental group

Description:

16 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Treatment:

Drug: EP-104IAR

EP-104IAR 120 mg

Experimental group

Description:

20 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Treatment:

Drug: EP-104IAR