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New treatment option for Eosinophilic Esophagitis
Official title Zemaira Eosinophilic Esophagitis Pilot Study
ClinicalTrials.gov ID: NCT05485155
What this study is testing
What is Alpha-proteinase inhibitor?
Alpha-proteinase inhibitor is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for eosinophilic esophagitis.
Also referred to as Zemaira.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, open-label drug study that will examine the effects of Zemaira (alpha-1 trypsin inhibitor) in patients with Eosinophilic Esophagitis.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Participant and/or legally authorized representative must be able to understand and provide informed consent prior to study procedures being...
- 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...
- History of approximately 8 week standard of care (SOC) treatment (e.g., proton pump inhibitors (PPI's), topical corticosteroids) that did not...
You likely can't join if
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Current active H. pylori infection. A history of H. pylori infection needs to have medical documentation of one of the three acceptable eradication...
- Another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome\ , Churg Strauss vasculitis, eosinophilic granuloma or a...
- Systemic gastrointestinal disorders such as Crohn's disease, inflammatory bowel disease, or Celiac disease not including chronic gastritis, chronic...
- Diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
- Known immunoglobulin A (IgA) deficiency (i.e., IgA level \< 8 mg/dL at screening).
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- Willing to maintain current dietary regimen throughout the course of the study. Diet must have been stable for 8 weeks prior to baseline endoscopy.
What rules you out
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Current active H. pylori infection. A history of H. pylori infection needs to have medical documentation of one of the three acceptable eradication tests: antigen, breath or histology. Participants with current active...
- Another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome\ , Churg Strauss vasculitis, eosinophilic granuloma or a parasitic infection). \ Hypereosinophilic syndrome defined by multiple...
- Systemic gastrointestinal disorders such as Crohn's disease, inflammatory bowel disease, or Celiac disease not including chronic gastritis, chronic duodenitis, mucosal eosinophilia or other EGID's.
- Diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
- Known immunoglobulin A (IgA) deficiency (i.e., IgA level \< 8 mg/dL at screening).
- Current coronavirus disease of 2019 (COVID-19) infection (i.e., detection of the presence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) before the screening endoscopy using testing done at the...
- Hematological disorders that prevent the blood from clotting (e.g., hemophilia, Von Willebrand disease, clotting factor deficiencies).
- Currently on anti-coagulation medications (except aspirin/Non-steroidal anti-inflammatory drugs).
- Known history of hypersensitivity following infusions of human blood or blood components (e.g., human immunoglobulins or human albumin).
- Known history of hypersensitivity or anaphylaxis to Zemaira or other A1AT products.
- Uncontrolled, or poorly controlled, comorbid conditions including, but not limited to, cardiovascular diseases, hypertension and diabetes as defined by the following criteria:
- 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
- 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...
- Current or recent use of any investigational drug (within 3 months or 5 half-lives, whichever is longer, prior to screening).
- Currently participating or planning to participate in another clinical study involving an investigational drug during the course of this study.
- Presence of steroid-responsive diseases (e.g., asthma) with a recent (within the last 6 months) history of disease exacerbations requiring steroid treatment.
- Current use of systemic steroids with daily dose \> 10 mg for any reason or steroid burst for \> 3 days within 1 month of screening.
- Current pregnancy or breastfeeding.
- Any esophageal stricture unable to be passed with a standard, diagnostic upper endoscope.
- Esophageal varices or treatment 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.
- History of alcohol or drug abuse within 6 months prior to screening.
- Participant or his/her immediate family is a member of the investigational team.
- Presence of clinically significant laboratory abnormalities at the screening that meets one or more of the following criteria:
- Serum alanine aminotransferase (ALT) ≥ 3 times upper limit of normal (ULN)
- Serum total bilirubin ≥2 times ULN
- Absolute neutrophil count (ANC) ≤ 1000 cells/mm3
- Hemoglobin (Hgb) ≤ 10.0 g/dL
- Platelet count ≤ 100,000/mm3
- Glomerular Filtration Rate (GFR) ≤ 44 mL/min/1.73 m2
- Planned or anticipated major surgical procedure during the study.
- Known or suspected immunodeficiency disorder, including human immunodeficiency disorder (HIV) or a history of invasive opportunistic infections (e.g., tuberculosis, non-tuberculous mycobacterial infections...
- Planned or anticipated use of any prohibited medications and procedures during the study.
- Currently on Zemaira for other indications.
- Initiation, discontinuation or change in the dosage regimen of the following medications within 8 weeks prior to the baseline endoscopy: Proton pump inhibitors Leukotriene inhibitors Nasal and/or inhaled corticosteroids...
- Presence of the following esophageal disorders: achalasia cardia, Barrett's esophagus or precancerous lesions noted on the endoscopy.
- Women of childbearing potential, or male participants with female partners of childbearing potential, who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment...
- Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) for one month prior to...
- Intrauterine device; intrauterine hormone-releasing system
- Bilateral tubal ligation
- Vasectomized partner
- And/or sexual abstinence
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.