VE416 for Treatment of Food Allergy
ConditionPeanut Allergy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-55
SponsorMassachusetts General Hospital
About this trial
This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Vancomycin plus VE416 before PNOIT
- Vancomycin plus VE416 with PNOIT
- Placebo plus VE416 with PNOIT
- Placebo plus placebo with PNOIT
Treatment groups
60 Participants
are divided into 4 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Vedanta Biosciences, Inc.
Collaborator
Source ClinicalTrials.gov