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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Vancomycin plus VE416 before PNOIT
Combination productVancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks followed by PNOIT
Vancomycin plus VE416 with PNOIT
Combination productPlacebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT
Placebo plus VE416 with PNOIT
Combination productPlacebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT
Placebo plus placebo with PNOIT
Combination productPlacebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by placebo for VE416 PO QD x 6 weeks with concomitant PNOIT
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: vancomycin plus VE416 before PNOITExperimental treatment 1 intervention
Group B: Vancomycin plus VE416 with PNOITExperimental treatment 1 intervention
Group C: Placebo plus VE416 with PNOITExperimental treatment 1 intervention
Group D: Placebo plus placebo with PNOITActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Endpoint- Phase 1b
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame
7 weeks2
Primary Endpoint- Phase II
The geometric mean of the maximum tolerated dose (MTD) of peanut protein at DBPCFC1
Time frame
23 weeks, with 24 week Post-Phase II maintenance phase followed by a DBPCFCSecondary outcomes
1
Secondary Endpoint- Efficacy
The percentage of patients tolerating 600 mg (1030 mg cumulative) at DBPCFC1 without treatment
Time frame
54 weeks2
Secondary Endpoint- Safety
The occurrence of treatment related adverse events
Time frame
54 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Vedanta Biosciences, Inc.
Collaborator
Source ClinicalTrials.gov