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Peanut Allergy clinical trials

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NCT ID: NCT04761835 Withdrawn - Food Allergy Clinical Trials

STEP-IT-UP - Peanut Allergy Study for Infants

Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

Multicenter randomized (1:1) trial of strict avoidance versus sub-threshold dietary introduction of peanut in peanut allergic infants 4-14 months of age who react at a minimum cumulative dose of at least 430 mg of peanut protein at initial oral food challenge (OFC) for 12 months, followed by cross-over to sub-threshold dietary introduction of peanut in those randomized initially to avoidance.

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: NCT04511494 Active, not recruiting - Peanut Allergy Clinical Trials

Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT

SmaChO
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

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 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.

NCT ID: NCT04415593 Recruiting - Peanut Allergy Clinical Trials

High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

In this trial the investigators aim to assess the effectiveness and safety of oral immunotherapy with peanut protein in high and low dose (300mg versus 150mg) in children with peanuts allergy.

NCT ID: NCT04371627 No longer available - Peanut Allergy Clinical Trials

Viaskin® Peanut (DBV712) Expanded Access Protocol

Start date: n/a
Phase:
Study type: Expanded Access

This is an open label expanded access program for male and female patients ≥ 4 years old.

NCT ID: NCT04222491 Enrolling by invitation - Peanut Allergy Clinical Trials

Food Oral Immunotherapy for Peanut Allergy

Start date: June 25, 2020
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04163562 Recruiting - Peanut Allergy Clinical Trials

Oral Immunotherapy for Peanut Allergic Patients

Start date: March 6, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Multicenter, double-blind, randomized, placebo-controlled phase I/II study to determine the safety, tolerability, potential efficacy and dose finding of INP20, an oral immunotherapy in peanut-allergic patients. The overall study design consists of two sequential periods of Part A and Part B. Part A is a dose escalation study in patients from 12 to 65 years old with a history of immediate hypersensitive reaction to peanut protein. Six diferent oral-dose of INP20 will be administered to 6 cohorts of patients once daily for 2 weeks. Part B is a 6-month double-blind, placebo-controlled, randomized and parallel groups study. Patients will be randomized in a 1:1:1 ratio into three (3) different treatment groups, including placebo and the two doses of peanut protein selected from Part A. They will recieve INP20 once daily for 6 months.

NCT ID: NCT03936998 Recruiting - Peanut Allergy Clinical Trials

VE416 for Treatment of Food Allergy

Start date: June 28, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

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.

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: 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.