Actively Recruiting
VE416 for Treatment of Food Allergy
Led by Massachusetts General Hospital · Updated on 2023-10-18
60
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
V
Vedanta Biosciences, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VE416 for Treatment of Food Allergy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- People aged 12 to 55 years with a documented medical history of peanut allergy
- Positive skin prick test to peanut (wheal at least 5 mm larger than saline control) or serum peanut-specific IgE ≥ 5 kU/L at screening
- Ara h 2 specific IgE > 0.35 kU/L at screening
- Willing to sign informed consent or have a parent/legal guardian sign if age appropriate
- Willing to sign assent form if age appropriate
- For Phase II continuation, must have allergic reaction needing treatment at ≥ 100 mg peanut protein during Entry Challenge
You will not qualify if you...
- History of severe anaphylaxis with hypoxia, low blood pressure, neurological compromise, or incontinence
- Moderate or severe asthma per NHLBI guidelines
- Poorly controlled asthma defined by FEV1 < 80% or frequent symptoms or rescue medication use
- Other severe medical problems including autoimmune, chronic immune inflammatory, or gastrointestinal inflammatory conditions
- Unable to cooperate with or perform oral food challenge procedures
- Unable to swallow size 0 capsule
- Primary immune deficiency
- Allergy to oat confirmed by skin prick test and history
- Current use of beta blockers, ACE inhibitors, or monoamine oxidase inhibitors
- Women who are pregnant, planning pregnancy, or breastfeeding
- Low hematocrit (<0.36 females, <0.38 males) or weight < 23 kg
- Use of systemic immunomodulatory treatments or biologics targeting immune system within past 6 months
- Other medical conditions or findings that increase risk or interfere with study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
W
Wayne G Shreffler, MD, PhD
CONTACT
J
Jannat Gill, BDS, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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