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Peanut Hypersensitivity clinical trials

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NCT ID: NCT03881696 Active, not recruiting - Peanut Allergy Clinical Trials

Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

OUtMATCH
Start date: July 22, 2019
Phase: Phase 3
Study type: Interventional

This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.

NCT ID: NCT03859700 Enrolling by invitation - Peanut Allergy Clinical Trials

Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children

EPOPEX
Start date: December 6, 2018
Phase: Phase 3
Study type: Interventional

Open-label, follow-up study for subjects who completed the EPITOPE study.

NCT ID: NCT03852342 Completed - Peanut Allergy Clinical Trials

Reactive Doses and Times During Oral Food Challenge to Peanut

PeaNewT
Start date: October 10, 2018
Phase:
Study type: Observational

Peanut allergy is a growing public health problem in developed countries with more and more hospitalizations for anaphylaxis. It has been determined that sensitization to certain peanut proteins such as rAra h 2, is predictive of allergy and could predict the severity of reaction (anaphylaxis) during Oral food challenges (OFC). So far, consensual threshold for cutaneous test and IgE as predictor in the positivity of OFC have not been determined. Identification of reactive doses for OFC and phenotype of patients would help to personalize management of patients subgroups, with an optimal security.

NCT ID: NCT03849079 Terminated - Peanut Allergy Clinical Trials

Validation of the HYPONUT Product

Start date: September 24, 2019
Phase: N/A
Study type: Interventional

The HYPONUT product was previously validated in a laboratory setting ("Procédé de préparation d'aliment hypoallergénique", n° FR1250977) on 2012. A international patent was then obtained on 2013. Through the present study, the investigators would like to prove that the hypoallergenicity of the product is sustained in a clinical setting. Patients allergic to peanuts currently undergo in vivo tests to confirm their allergy: skin prick tests, and oral food challenges. In vitro tests are also performed (i.e. IgE levels for peanut and peanut components). The follow-up of patients consists in regular yearly or semestral evaluations. During one of these evaluation, the investigators will skin tests patients with the hyponut product to verify if they are sensitized to this last one as well. When skin tests will be negative, the investigators will propose to patients to take some of the product to verify its tolerability as well.

NCT ID: NCT03835767 Recruiting - Clinical trials for Milk and/or Peanut Allergy

Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis

Start date: April 19, 2019
Phase: Phase 2
Study type: Interventional

Background: Atopic dermatitis (AD), also called eczema, makes skin dry, red, and itchy. People with AD are more likely to get a food allergy than people without AD. But some food allergy tests are not always accurate in people with AD. Researchers want to study if people are truly allergic to milk and/or peanuts. Objectives: To improve the ways doctors test for food allergy in people with AD. Eligibility: People ages 3 21 who have had AD; have a high total IgE level (an allergic antibody); might have a milk and/or peanut allergy; and are currently enrolled in another NIH study Design: Participants will be screened under another protocol. Participants will have a physical exam, blood tests, and medical history. Participants will breathe into a plastic device that measures lung strength. Participants may get a small plastic tube inserted in their arm. Participants who have not had an allergic reaction to food in the past 3 years will do 1 or more oral food challenge (OFCs) depending on their allergies. They will eat a little bit of the food they might be allergic to. They will be watched for a reaction. If they have one, they will know for sure they are allergic. They may keep eating bigger portions of the food until they either have a reaction or finish all the food. In some OFCs, participants will get a placebo food. OFCs will last a few hours or 2 days. Participants will repeat all tests at each OFC. Participation can last up to 12 months. ...

NCT ID: NCT03793608 Completed - Peanut Allergy Clinical Trials

Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

Start date: March 12, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who safely pass a double-blind placebo-controlled food challenge (DBPCFC) at week 24. The secondary objectives are: - To determine whether dupilumab treatment improves peanut tolerability, defined as a change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC - To evaluate the safety and tolerability of dupilumab treatment in peanut allergic patients - To evaluate the effects of dupilumab treatment on the levels of peanut-specific Immunoglobulin E (IgE) - To evaluate the treatment effect of dupilumab on the average wheal size after a titrated skin prick test (SPT), as measured by area under curve (AUC) of the average wheal size induced by peanut extract at different concentrations - To assess the incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab in patients over time

NCT ID: NCT03755713 Completed - Peanut Allergy Clinical Trials

A Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine

Start date: March 12, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal (ID) injection in adolescent participants with peanut allergy.

NCT ID: NCT03736447 Completed - Peanut Allergy Clinical Trials

Peanut Oral Immunotherapy Study of Early Intervention for Desensitization

POSEIDON
Start date: December 27, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to < 4 years.

NCT ID: NCT03703791 Terminated - Peanut Allergy Clinical Trials

Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents

Start date: October 24, 2018
Phase: Phase 3
Study type: Interventional

To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODITâ„¢) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17 years.

NCT ID: NCT03682770 Completed - Peanut Allergy Clinical Trials

Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)

Start date: October 3, 2018
Phase: Phase 2
Study type: Interventional

Primary objective is to assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a post up-dosing double-blind placebo-controlled food challenge (DBPCFC) at visit 16. Secondary objectives are: - To assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the cumulative tolerated dose (log transformed) of peanut protein during a post up-dosing DBPCFC at visit 16 - To assess whether dupilumab as (indefinite [continuously]) adjunct to AR101 compared to placebo maintains desensitization, defined as an increase in the proportion of participants who pass a post maintenance DBPCFC at visit 22 - To assess whether dupilumab as (limited [previously]) adjunct to AR101 compared to placebo maintains desensitization, defined as an increase in the proportion of participants who pass a post maintenance DBPCFC at visit 22 - To evaluate the safety and tolerability of dupilumab as adjunct to AR101 compared to placebo - To assess the effect of dupilumab (compared to placebo) as adjunct to AR101 on the change in peanut-specific Immunoglobulin E (sIgE), Immunoglobulin G (IgG), Immunoglobulin G4 (IgG4), and peanut-specific IgG4/IgE ratio - To assess if dupilumab increases the tolerability of AR101 as measured by the daily symptoms (electronic diary [e-diary]) during the up-dosing phase