BridgeMD
New treatment option for Peanut Allergy
Official title VE416 for Treatment of Food Allergy
ClinicalTrials.gov ID: NCT03936998
What this study is testing
What is Vancomycin plus VE416 before PNOIT?
Vancomycin plus VE416 before PNOIT is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for peanut allergy.
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 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 55
You may be able to join if
- 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...
- 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.
You likely can't join if
- History of severe anaphylaxis as defined by hypoxia (cyanosis or SpO2 \ 30% below predicted normal for sex, height, weight or from known baseline)...
- Severe or Moderate asthma as defined using the severity criteria of the current NHLBI Guidelines for the Diagnosis and Management of Asthma...
- Poorly-controlled asthma as defined by FEV1 \ 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...
- Inability to cooperate with and/or perform oral food challenge procedures.
- Inability to swallow size 0 capsule
See the full eligibility 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.
- History of severe anaphylaxis as defined by hypoxia (cyanosis or SpO2 \ 30% below predicted normal for sex, height, weight or from known baseline), neurological compromise (confusion, loss of consciousness), or...
- 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 \ 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, 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, 12 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, 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.