OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity...
Peanut AllergyThis is a phase 1, multi-center, randomized, double-blind, placebo-controlled study in adult participants with peanut allergy. Participants will be randomized in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. The treatment group will be blinded to the investigator, participants, and the Intrommune study team.
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)...
Peanut AllergyThe purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.
Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy...
Peanut AllergyThe PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous immunotherapy (EPIT).
The Peanut Oral Immunotherapy Study: Safety, Efficacy and Discovery
Peanut AllergyDetermine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed after the initial 3 month avoidance period Secondary Objectives: Identify the basic immune mechanisms which can explain the differences in the effects of OIT in desensitized vs. tolerant individuals. Determine whether immune monitoring measurements reflecting underlying mechanisms during OIT can be used to predict responses to OIT in individual subjects and, ultimately, to improve the safety and efficacy outcomes in peanut OIT protocols.
Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy
Peanut AllergyThe purpose of this phase 1b study is to evaluate the safety and tolerability of repeated epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device) in peanut allergic subjects.
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for...
Peanut HypersensitivityFood Hypersensitivity1 moreThe purpose of this study is to explore the safety and efficacy of a sublingual (under the tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in inducing desensitization and long term tolerance in children with persistent peanut allergy.
Peanut Epicutaneous Phase II Immunotherapy Clinical Trial
Peanut HypersensitivityFood Hypersensitivity3 moreFood allergy occurs when the immune system reacts against foods. The immune system is the part of the body that protects us from illness and germs, but it can also cause allergies. Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries. There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be severe and life threatening. The only way that you can prevent an allergic reaction is to avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and people can be accidently exposed to peanut proteins. Treatment for accidental exposure include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin) which must be carried at all times. DBV Technologies has developed an epicutaneous delivery system, a patch that puts the peanut protein on the skin.
Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children...
Peanut AllergyThe objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: To assess the efficacy of Viaskin Peanut after up to 36 months of treatment. To evaluate the safety of long-term treatment with Viaskin Peanut. To evaluate sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after treatment with Viaskin Peanut.
Immunotherapy for Peanut Allergy
AllergyCurrently, when a food allergy is diagnosed, the "standard of care" is strict avoidance of the allergic food and ready access to self-injectable epinephrine. Yet, accidental ingestions do occur. Unfortunately, for a ubiquitous food such as peanut, the possibility of an inadvertent ingestion is great. It is estimated that over 50% of individuals who are allergic to peanuts will have an accidental reaction to peanuts over a 2-year period. The purpose of this study is to determine if peanut sublingual immunotherapy (SLIT) reduces the number and/or symptoms of accidental peanut ingestion in peanut allergic subjects. We would anticipate that the subjects on the peanut SLIT protocol would experience few adverse effects with accidental peanut ingestion over the course of the two years of SLIT. The primary endpoint to evaluate the effectiveness of SLIT will be a negative DBPCFC to peanuts (8 grams) at the completion of the two years of the study.
Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults
Food HypersensitivityHypersensitivity2 moreThe purpose of this study is to evaluate the safety and side effects of a study product that contains recombinant modified peanut proteins (EMP-123) in healthy and peanut-allergic participants. This is a first in human study. As of November 2009, this study is no longer recruiting healthy volunteers and will only be recruiting individuals with peanut allergies.