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Zemaira for Eosinophilic Esophagitis Pilot Study

This study is testing Zemaira (alpha-1 trypsin inhibitor) in people with Eosinophilic Esophagitis (an immune condition causing inflammation of the esophagus). Researchers want to see if Zemaira can change the level of a specific protein, alpha1 anti-trypsin (A1AT), in the esophagus after 4 weeks. They will also track any side effects for 20 weeks. You may be able to join if you are between 18 and 70 years old and have active Eosinophilic Esophagitis. This study plans to enroll 15 participants, but its current status (whether it's recruiting or not) is unclear.

Study design
This is a Phase II, open-label study, meaning both you and the study team will know you are receiving Zemaira. It plans to enroll 15 participants.
What's involved
You would receive weekly intravenous infusions of Zemaira for 4 weeks. You would also have assessments during treatment and for 12 weeks after your last dose.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 12 weeks after your last dose of the study drug.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05485155

Zemaira Eosinophilic Esophagitis Pilot Study

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Children's Hospital Medical Center, Cincinnati
~15 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Alpha-proteinase inhibitor

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in esophageal alpha1 anti-trypsin (A1AT) concentration
Measured over 4 weeks
+1 more outcome measured

Conditions

Eosinophilic Esophagitis

Explore related trials

Eosinophilic Esophagitis

Where it's being run

2 sites across 2 states
Maryland1
Ohio1

Study leadership

  • Marc Rothenberg · PRINCIPAL_INVESTIGATOR · Cincinnati Children's Hospital Medical Center

Who to contact

Regina Yearout
[email protected]
(513) 517-2108
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

A myocardial infarction within the last 6 months.
Blood pressure \> 179/99 mmHg
Diabetics with a hemoglobin A1C (HbA1C) \> 7% and that are deemed to have uncontrolled diabetes as defined by the physician 13. History of cancer: Individuals who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the participant is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained. Individuals who have had other malignancies are eligible provided that the individual is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained. 14. Current or recent use of any investigational drug (within 3 months or 5 half-lives, whichever is longer, prior to screening). 15. Currently participating or planning to participate in another clinical study involving an investigational drug during the course of this study. 16. Presence of steroid-responsive diseases (e.g., asthma) with a recent (within the last 6 months) history of disease exacerbations requiring steroid treatment. 17. Current use of systemic steroids with daily dose \> 10 mg for any reason or steroid burst for \> 3 days within 1 month of screening. 18. Current pregnancy or breastfeeding. 19. Any esophageal stricture unable to be passed with a standard, diagnostic upper endoscope. 20. Esophageal varices or interventional treatment for esophageal varices that, in the opinion of the investigator, would put the participant at undue risk for significant complications from an endoscopy procedure. 21. History of alcohol or drug abuse within 6 months prior to screening. 22. Participant or his/her immediate family is a member of the investigational team. 23. Presence of clinically significant laboratory abnormalities at the screening that meets one or more of the following criteria:

What this trial measures

  • Change in esophageal alpha1 anti-trypsin (A1AT) concentration4 weeks

    Absolute change from baseline A1AT esophageal concentration in participants receiving Zemaira to 24 hours after the last infusion at 4 weeks

  • Adverse events20 weeks

    The number of Adverse Events (AE), including Serious Adverse Events (SAE), related to the study drug.