A Phase 1b/2a, Open Label Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104IAR in Adults with Eosinophilic Esophagitis (RESOLVE)

Recruiting

• Conditions: Digestive system disorder; Swelling of esophagus; 10017969

• Registration Number: NL-OMON56323
• Lead Sponsor: Eupraxia Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

1. Adults 18 to 75 years of age, inclusive
2. Symptomatic EoE defined as:
a. SDI >= 5 at screening and baseline
b. Confirmed historical diagnosis of EoE with PEC > 15/hpf
3. For women of childbearing potential, a negative pregnancy test (at baseline)
and willing to use a
highly effective method of birth control between baseline and end of study
4. Willing and able to adhere to study-related procedures and visit schedule
5. Willing and able to provide informed consent

Exclusion Criteria

1. 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
2. Presence of oral or esophageal mucosal infection of any type (bacterial,
viral, or fungal)
3. Any oropharyngeal or dental condition that prevents normal eating
4. Known severe esophageal motility disorders other than EoE
5. 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.)
6.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.
7. Known hypersensitivity, or intolerance to corticosteroids, or to any of the
ingredients in the investigational medicinal product, including carboxymethyl
cellulose, hyaluronic acid, and polysorbate 80, or to the ingredients in
Synacthen (used in the ACTH stimulation test)
8. Use of systemic corticosteroids within 60 days prior to baseline, or
swallowed topical corticosteroids within 60 days prior to baseline, or extended
use of high-potency dermal topical corticosteroids within 60 days prior to
baseline
09. Use of a new inhaled or intranasal corticosteroid within 60 days prior to
baseline, or a change in dose of an inhaled or intranasal corticosteroid within
60 days of baseline (a temporary dose change lasting <= 14 days is permitted)
10. Initiation of an elimination diet or elemental diet within 30 days prior to
baseline (dietary therapy must remain stable throughout the study)
11. Use of biologic immunomodulators in the 90 days prior to baseline
12. Use of immunosuppressive drugs, or potent cytochrome CYP3A4 inhibitors in
the 90 days prior to baseline
13. Initiated, discontinued, or changed dosage regimen of PPIs for any
condition such as GERD or allergic rhinitis within 4 weeks prior to baseline.
Doses must remain stable throughout the study
14. Morning serum cortisol level <= 5 µg/dL (138 nmol/L) at Screening visit
15. Use of another investigational product within the 30 days prior to
baseline, or an investigational biologic within 90 days prior to baseline, or
current/planned participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety<br /><br>• Frequency and severity of treatment-emergent adverse events (TEAEs)<br /><br>• Change from baseline in clinical safety laboratory measurements at Weeks 4<br /><br>and 12<br /><br>• Change from baseline in morning serum cortisol levels 24 hours postdose and<br /><br>at Weeks 2, 4, 8, 12, and 24 and Week 52 for participants who receive >40 mg<br /><br>total dose<br /><br>• Change from baseline in vital signs at 1 and 24 hours postdose and at Weeks<br /><br>2, 4, 8, 12 and physical examination results at Weeks 2, 4, 8, 12<br /><br><br /><br><br /><br>Pharmacokinetics:<br /><br>• Plasma concentrations of FP, measured at baseline (predose), 2 and 24 hours<br /><br>postdose, and at Weeks 2, 4, 8, 12, 24, and Weeks 36 and 52 for participants<br /><br>who receive >40 mg total dose.</p><br>