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Peanut Hypersensitivity clinical trials

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NCT ID: NCT05038904 Completed - Food Allergy Clinical Trials

Preventing Anaphylaxis With Acalabrutinib

Start date: December 16, 2021
Phase: Phase 2
Study type: Interventional

Food allergy is a potentially life-threatening condition, and its prevalence continues to increase despite public health efforts. There are currently no known therapies that can reliably prevent food-induced anaphylaxis. This is an open-label study designed to determine the ability acalabrutinib to prevent signs and symptoms of anaphylaxis during an oral food challenge in food-allergic adults.

NCT ID: NCT04603300 Completed - Peanut Allergy Clinical Trials

OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut

Start date: May 15, 2021
Phase: Phase 1
Study type: Interventional

This 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.

NCT ID: NCT03907397 Completed - Food Allergy Clinical Trials

Immune and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy

CAFETERIA
Start date: August 5, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine whether allowing ingestion of sub-threshold amounts of peanut in those with a high threshold (tolerate at least 143 mg peanut protein on supervised double-blind, placebo-controlled oral food challenge [DBPCFC]) will be associated with attaining even higher thresholds over time in children with high threshold peanut allergy compared to those avoiding peanut. The secondary clinical objectives include assessing the development of sustained unresponsiveness (SU, a surrogate term for tolerance without daily ingestion), effects on quality of life, and safety compared to those avoiding peanut. Additionally, this study will phenotype the allergic response to peanut based on threshold and response to exposure. Mechanistic study objectives will determine the immune and molecular basis of the high threshold endotype, identify predictors of response to exposure, and determine mechanisms and biomarkers of remission.

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: 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: 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

NCT ID: NCT03648320 Completed - Peanut Allergy Clinical Trials

The Grown Up Peanut Immunotherapy Study

GUPI
Start date: October 15, 2018
Phase: N/A
Study type: Interventional

To determine efficacy and safety of peanut oral immunotherapy in adults with peanut allergy.

NCT ID: NCT03546413 Completed - Peanut Allergy Clinical Trials

Follow up of LEAP Participants and Their Families

Start date: July 5, 2018
Phase:
Study type: Observational

This prospective, cross-sectional study was designed to improve understanding of how early-life introduction of peanuts may promote the maintenance of tolerance in adolescence and will serve as an additional safety evaluation of the original nutritional intervention.