VE416 for Treatment of Food Allergy

Launched by MASSACHUSETTS GENERAL HOSPITAL · May 1, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called VE416 to see how effective it is for people with peanut allergies. The trial will compare VE416 given before or during peanut oral immunotherapy (a method where small amounts of peanut protein are gradually given to help the body tolerate peanuts) to just the peanut oral immunotherapy alone. The trial is currently looking for participants between the ages of 12 and 55 who have a documented peanut allergy and can provide proof of this allergy through specific tests.

If you or someone you know is considering participating, you should be aware that participants will undergo a safe food challenge and will need to sign consent forms. However, certain individuals, such as those with a history of severe allergic reactions or specific medical conditions, may not be eligible to join. This trial could help researchers learn more about how to better treat peanut allergies and improve safety for people affected by them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • People of all ethnic/racial/gender groups aged 12-55 years old with a documented medical history of peanut allergy.
• • Evidence of peanut-specific IgE by either: positive skin prick test to peanut (reaction wheal at least 5 mm larger than saline control) or serum peanut-specific IgE _5 kU/L at screening visit.
• • Ara h 2 specific IgE \>0.35 kU/L at screening visit.
• • Willing to sign informed consent or whose parent or legal guardian is willing to sign the consent form (age appropriate).
• • Willing to sign the assent form, if age appropriate.
• • (For continuation into Phase II only) Allergic reaction requiring treatment at _ 100 mg dose of peanut protein during Entry Challenge.
• Exclusion Criteria:
• • History of severe anaphylaxis as defined by hypoxia (cyanosis or SpO2 \<92% during reaction), documented hypotension (documented systolic BP \>30% below predicted normal for sex, height, weight or from known baseline), neurological compromise (confusion, loss of consciousness), or incontinence.
• • Severe or Moderate asthma as defined using the severity criteria of the current NHLBI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/).
• • Poorly-controlled asthma as defined by FEV1 \<80% or any of the following symptoms: nighttime awakening \>2 days/week or rescue medication use \>2 days / week.
• • Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
• • Inability to cooperate with and/or perform oral food challenge procedures.
• • Inability to swallow size 0 capsule
• • Primary Immune Deficiency
• • Allergy to oat confirmed by skin prick testing and history
• • Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors
• • Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
• • Hematocrit \<0.36 for adult females or \<0.38 for adult males Weight \<23 kg
• • Use within the past 6 months of other systemic immunomodulatory treatments including allergen immunotherapy, or use of biologics with an immune target, including omalizumab.
• • 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 study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study may also exclude a participant from the study.