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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: NCT04984876 Terminated - Allergy, Peanut Clinical Trials

Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy

Start date: December 7, 2021
Phase: Phase 3
Study type: Interventional

This is a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) subcutaneous injection every 4 weeks (SCq4w) in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy.

NCT ID: NCT04974970 Terminated - Food Allergy Clinical Trials

Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy

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

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.

NCT ID: NCT04950504 Terminated - Peanut Allergy Clinical Trials

Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-201 in Subjects Ages 16-35 With Peanut Allergy

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

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.

NCT ID: NCT04887441 Active, not recruiting - Food Allergy Clinical Trials

Allergology: Information, Data and Knowledge Organization

ALLERGIDOC
Start date: September 1, 2019
Phase:
Study type: Observational

Digital technology is essential in the field of health, via connected objects, the medical Internet or even telemedicine; and the info-communication practices (ways of getting information and communicating) of the actors go through digital devices. In addition, at present, the mass of activity documents to be managed in healthcare establishments and an abundant supply of documentary resources in health, available on the Internet, lead to infobesity, information pollution, and work overload. These phenomena lead to an increase in the time spent searching for relevant information and even to the burnout of healthcare professionals. A contextualization of the information communication systems through which the practices of health professionals pass therefore seems necessary so that the tools for managing, extracting and organizing knowledge can support these actors in their work. In the field of allergies, there are many players, and the information that is useful to them is abundant and heterogeneous. This study is based on the hypothesis that a knowledge organization model, developed from existing practices, could make it possible to obtain satisfactory results when searching for information, and be integrated into the daily practices of actors by linking up with other already existing systems and tools.

NCT ID: NCT04881773 Active, not recruiting - Peanut Allergy Clinical Trials

Oral Low Doses Tolerance INduction Study for Peanuts

OLDTINYpeanut
Start date: September 1, 2018
Phase:
Study type: Observational

Several protocols have been proposed in scientifis literature, for oral tolerance induction (OIT) protocols for peanuts. A meta-analysis showed that the data in the literature are rather in favor of the exclusion of peanuts, and that OIT doesn't allow to expect significant levels of peanut protein consumed by the patient, and is associated with an increased risk of anaphylaxis and epinephrine use. Also, in most published protocols, patients with a history of anaphylactic shock, severe asthma, or multiple history of anaphylaxis are excluded. To date, no protocol has been validated for this type of treatment, and each center follows locally validated schemes. In our unit, the investigators use an OIT protocol that starts at low doses (first dose at 2.68 mg peanut protein) and doses increase is scheduled every 4 to 12 weeks (instead of every 2 weeks). The investigators do not exclude patients with asthma or those with a history of peanut anaphylaxis (grade 2 or 3). The investigators have noted that our protocol is associated with a good safety profile and good efficacy, probably due to the fact that the investigators start at low doses and increase the dose with a prolonged delay, compared to previously published protocols. For this reason, the investigators decided to evaluate the results the investigators obtained in our patients and to better analyze the efficacy and safety profile of our protocol.

NCT ID: NCT04872218 Active, not recruiting - Peanut Allergy Clinical Trials

Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy

ATARI
Start date: March 1, 2022
Phase: Phase 2
Study type: Interventional

This is a phase 2a, multi-center, randomized and double-blind placebo-controlled trial comparing 24 weeks of abatacept versus placebo used as adjuvant to oral immunotherapy to induce remission in adolescents and adults with persistent severe peanut allergy. This is a proof-of-concept trial in which the primary outcome will be the suppression of the initial peanut specific IgE surge during OIT, which is used as a proxy outcome of peanut allergy remission. Adolescents and adults with persistent severe peanut allergy (n=14) will be randomized to either abatacept or placebo at a ratio 1:1 for a total period of 24 weeks. Peanut oral immunotherapy will be initiated the day following the first administration of the investigational product. Sustained tolerance to peanut will be assessed at 36 weeks.

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: NCT04604431 Enrolling by invitation - Clinical trials for Food Allergy in Infants

Intervention to Reduce Early (Peanut) Allergy in Children

iREACH
Start date: November 4, 2020
Phase: N/A
Study type: Interventional

iREACH is a five-year NIH funded study aimed at assessing and improving pediatric clinician adherence to the 2017 NIAID Prevention of Peanut Allergy (PPA) Guidelines. iREACH has been developed as an electronic health record (EHR) integrated Clinical Decision Support (CDS) tool together with educational modules on the PPA guidelines to assist clinicians in implementing the 2017 NIAID PPA Guidelines. A practice-based, two-arm, cluster-randomized clinical trial will evaluate the effectiveness of iREACH in increasing pediatric clinician adherence to the PPA Guidelines and explore the end-goal of reducing peanut allergy incidence by age 2.5 years in the intervention vs control group. This study has the potential to: 1) provide evidence regarding the effectiveness of iREACH in promoting clinical processes and outcomes related to the PPA Guidelines, 2) provide important insight about practice-based implementation of PPA Guidelines by pediatric clinicians, allergists and caregivers, and 3) facilitate rapid, widespread implementation of PPA Guidelines and reduce peanut allergy incidence across the US.

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.