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Showing 1-20 of 37 trials
NCT06256146
Protocols for Oral Immunotherapy (OIT) for the main food allergens have been recently incorporated in clinical practice for food allergies and their clinical benefits have been acknowledged in European and Canadian official guidelines. There has been some reluctance in both clinicians and patients to implement these therapies, primarily because of the risk of allergic reactions during the desensitization process. This study will investigate if protocols using low doses of a food allergen or processed versions of the allergen can be both effective in conferring desensitization while inducing fewer allergic symptoms during the desensitization process.
NCT05424731
This is an open label expanded access program for male and female patients 2 years or older, to provide continued desensitization treatment with DBV712 250 mcg.
NCT03881696
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.
NCT03835767
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. ...
NCT05695261
This is a phase II trial that aims at evaluating the safety and tolerability of oral encapsulated fecal microbial transplantation therapy (MTT) in peanut allergic patients. In this research the investigators would like to learn more about ways to treat peanut allergies. The primary objective for Part A is to evaluate whether MTT with antibiotic pretreatment can increase the threshold of peanut reactivity during a double-blind placebo-controlled food challenge from \<=100 mg peanut protein to 300 mg after 28 days of MTT /placebo therapy and 4 months post therapy initiation. The primary objective for Part B is to evaluate whether MTT with antibiotic pretreatment can lead to sustained unresponsiveness (SU) defined as tolerating the same dose of peanut protein administered during a food challenge at baseline and 12 weeks after OIT cessation.
NCT07117669
This is a Phase 1/2 study to evaluate the safety and clinical activity of ENP-501 in non-peanut allergic (NPA) healthy participants and participants with an established peanut allergy (PA)
NCT03859700
Open-label, follow-up study for subjects who completed the EPITOPE study.
NCT04511494
Open label study with peanut oral immunotherapy (OIT). Peanut allergic children aged 1-3 years of age will be randomized 2:1 to: 1. Peanut OIT with slow up-dosing (40-60 weeks) up to a maintenance dose of 285 mg daily oral peanut protein or 2. Control group with peanut allergic children who do not undergo OIT. 3. In addition, a group of healthy children without allergic diseases will be included in the study. The primary outcome is tolerance to at least 750 mg peanut protein at a challenge after 3 years and sustained unresponsiveness (i.e. tolerance) to 750 mg peanut protein after 3 years of OIT followed by 4-6 weeks of avoidance. Efficacy and safety will be compared between group 1 and 2. Group 3 is a control group for analyses of immunological markers.
NCT03907397
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.
NCT02851277
The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal or intramuscular injection in adults with peanut allergy.
NCT03648320
To determine efficacy and safety of peanut oral immunotherapy in adults with peanut allergy.
NCT02149719
Peanut allergy is increasingly common, especially in countries such as UK and Australia. There is currently no accepted routine clinical therapy to cure peanut allergy. Recently studies have looked at desensitising people with peanut allergy by giving them small daily doses of roasted peanut. Although this therapy works for some people, its effects are not generally long lasting and it is associated with many side effects during protocol, resulting in a significant rate of drop-outs. Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may therefore provide a safer way of inducing desensitisation in patients who are allergic to roasted peanut, by first inducing tolerance to boiled peanut. Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted peanut, in peanut-allergic individuals.
NCT03682770
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
NCT04222491
This is an open label observational single center study of clinical food oral immunotherapy outcomes with biomarker samples and participant and/or caregiver-completed questionnaires in participants between 6 months and 65 years of age with IgE-mediated peanut allergy undergoing food oral immunotherapy.
NCT04950504
This study is a two-part Phase 1b/2a First-in-Human (FIH) randomized, double-blind, placebo-controlled clinical trial to assess the safety, tolerability, pharmacodynamics, and efficacy of multiple ascending doses of CNP-201 in Part A, with the goal of identifying a safe and tolerable dose level to be evaluated further in a larger number of subjects in Part B.
NCT04974970
The purpose of this trial is to assess the safety and efficacy of peanut immunotherapy in children and adults with peanut allergy. Participants will receive immunotherapy with peanut every 2 weeks for a period of 3 months.
NCT05662800
The aim of the study is to assess the prevalence of peanut, tree nuts, and sesame allergy in Polish children at high risk of food allergy. Additionally, the timing of the development of peanut, tree nuts and sesame allergy in the first three years of life in a high-risk population will be assessed.
NCT01955109
The 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.
NCT03793608
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
NCT02304991
Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. \[Time Frame: Baseline, 36 months\] Secondary Objectives: A secondary outcome of this objective will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance). To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. \[Time Frame: Baseline, 39 months\]