An Open-Label Study of Zemaira (Alpha 1-Trypsin Inhibitor) in Subjects With Eosinophilic Esophagitis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a prospective, open-label drug study that will examine the effects of Zemaira (alpha-1 trypsin inhibitor) in patients with Eosinophilic Esophagitis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Participant and/or legally authorized representative must be able to understand and provide informed consent prior to study procedures being performed.

• Willing and able to comply with study visits and activities

• Age ≥ 18 to ≤ 70 years at study enrollment

• Histologically active eosinophilic esophagitis (EoE) at time of screening or within 12 weeks prior to enrollment, with a peak count of ≥ 15 eosinophils (eos)/high powered field (hpf) in any region of the esophagus, with no other known cause for esophageal eosinophilia; involvement of eosinophilic inflammation in other gastrointestinal segments will be allowed but not required or sufficient.

• History of approximately 8 week standard of care (SOC) treatment (e.g., proton pump inhibitors (PPI's), topical corticosteroids) that did not adequately control or treat the EoE or documentation that such treatment was not tolerated. Participant may re-screen if this is not met.

• Stable medical management of EoE (and other eosinophilic disorders, if applicable) including stable dosage of medications in the 8 weeks prior to study enrollment, if applicable. Participants may be on baseline anti-EoE therapy (such as elimination diet, elemental diet, proton pump inhibitors (PPI), topical or systemic glucocorticoids (≤10 milligrams (mg) daily), immunosuppressive agents, cromolyn, and H1 and H2 anti-histamines) as long as there is agreement not to change their dosage.

• Willing to maintain current dietary regimen throughout the course of the study. Diet must have been stable for 8 weeks prior to baseline endoscopy.

Locations
United States
Maryland
The National Institutes of Health
RECRUITING
Bethesda
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Regina Yearout
Regina.Yearout@cchmc.org
(513) 517-2108
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2027-01
Participants
Target number of participants: 15
Treatments
Experimental: Active Drug
Zemaira alpha-proteinase inhibitor
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati
Collaborators: CSL Behring, National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov

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