Clinical Research Directory

Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy

The goal of this clinical trial is to evaluate the safety, pharmacokinetics, and effectiveness of MY006, a therapy designed to prevent severe or potentially life-threatening allergic reactions caused by accidental peanut intake. In the first part of the study, adult participants receive one dose or two doses of MY006 or a placebo, administered by subcutaneous injection. The safety of MY006, including the number of adverse events, injection-site reactions, and immunogenicity, in these participants will be reviewed by an independent Safety Monitoring Committee and, if the safety is judged acceptable, the second part of the study will be started. In the second part of the study, adult and adolescent participants with peanut allergy receive one dose of MY006 or a placebo, administered by subcutaneous injection. Several weeks later, the participants are given a food peanut challenge to assess reactions and treatment effects. The duration of the study for participants is for up to 32 weeks.

Efficacy, Safety and Pharmacokinetics of LP-003 in Peanut Allergic Patients

This study will evaluate the safety and efficacy of LP-003 for an increasing the amount of peanut protein that people with a peanut allergy can tolerate without having allergic symptoms. The study will include participants 12 to 55 years of age with a confirmed peanut allergy. Participants will be randomly assigned to receive LP-003 or placebo. LP-003 will be given by an injection under the skin (subcutaneous) once every 8 weeks during the first 24 weeks of treatment. Participants will not know the treatment they are receiving until the end of the study. The primary efficacy endpoints will be the proportion of participants in each group who successfully consume a single dose of ≥600 mg of peanut protein during a supervised double-blind, placebo-controlled food challenge at Week 24. Participants who complete the 24 weeks will continue for another 24 weeks in a blinded (participants will not know what treatment they are on) extension period, followed by a blinded follow-up period for continued safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments. The total study duration for each participant is approximately 84 weeks.

Flow CAST® Peanut Trial

This will be a multi-center, prospective evaluation, conducted at a minimum of four (4) U.S. sites. Sites will enroll peanut allergic subjects, subjects with allergies other than peanut and apparently healthy non-atopic control subjects and collect blood samples for testing using Flow CAST® and the comparative ImmunoCAP sIgE test.

Multi-Food Oral Immunotherapy for Peanut and Tree Nuts

This study aims to evaluate the efficacy and safety of multi-food oral immunotherapy (multi-OIT) using peanut and tree nuts proteins in children with confirmed food allergy to at least two allergens. Participants will be randomized in a 2:1 ratio to receive either multi-OIT or standard management consisting of an elimination diet. The primary objective is to evaluate immunotherapy efficacy defined as achieving tolerance to a cumulative dose of 4444 mg of protein during an oral food challenge (OFC-2) for at least one allergen that elicited a reaction during baseline challenge (OFC-1), compared with the control group. Secondary outcomes include the proportion of participants tolerating multiple allergens at the target cumulative dose; the incidence, type, and severity of adverse events classified according to the World Allergy Organization (WAO) grading system; changes in immunological parameters, including allergen-specific IgE and IgG4 levels; changes in skin prick test responses; changes in the quality of life of patients and their families.

BÜHLMANN BAT (Basophil Activation Test) in Allergy Diagnosis (Exploratory Pilot Study)

The goal of this exploratory pilot study is to generate early data needed for future validation studies of the automated BÜHLMANN BAT (Basophil activation test) assay. The main questions it aims to answer are: Does the BAT assay use the optimal allergen concentrations for stimulation, and how do its preliminary cut-offs perform in a real-world clinical scenario? Participants older than 1.5 years who are being evaluated for possible allergy sensitization will provide one additional blood tube during their routine blood draw as part of the regular medical care. The study involves only one visit and does not provide direct personal benefit.

A Long Term, Observational Follow-Up Study of Children and Young People Who Underwent an 18-Month Course of Oral Immunotherapy Treatment for Peanut, Egg or Milk Allergy (5-15 Years Post-Treatment)

The goal of this observational study is to learn about the long-term outcomes of children and young people who underwent an 18-month course of oral immunotherapy (OIT) treatment for peanut, egg or milk allergy. It aims to: • Compare long-term changes in health-related quality of life (HRQL) at 5-15 years after stopping OIT in participants who achieved remission and those who did not. Participants will attend a single follow-up visit for: * A blood test * Skin prick test (SPT) * Allergy questionnaires

The Role of Filaggrin Mutations and Sensitization Pathways in Allergic Rhinitis and Peanut Allergy

Caucasian male and female participants age 18 years of age and older will be enrolled in this study if they have known birch or peanut allergies or known to be non-atopic. Participants will undergo skin testing to confirm their allergies if not completed in the last 12 months. Medications and medical history will be captured with a focus on atopic disorders. Participants will undergo birch and peanut patch testing to assess penetration and if potential correlation exists with filaggrin genotyping and phenotyping. Blood samples will be drawn from participants and DNA isolated for genotyping of null mutations in filaggrin.

Blood Samples for the Study of Peanut, Tree Nut and Other Food Allergies

Food allergies are now a major problem. These experiments involve getting blood from people with food allergies and from people without food allergies. The blood collected will be used to answer questions and find information about peanut and other food allergies. Samples will come from: * People signed up by the investigators at the University of Colorado Denver * University of North Carolina, Massachusetts General Hospital, Children's Hospital of Colorado and the Immune Tolerance Network (Benaroya Research Institute) where people have been treated for peanut allergies * University of North Carolina, Massachusetts General Hospital, National Jewish Health and The Children's Hospital in Denver where people have taken part or will take part in clinically indicated oral food challenges. Blood and health histories from the University of North Carolina, Massachusetts General Hospital, National Jewish Health, The Children's Hospital and the Immune Tolerance Network will not have personal information linked. The specific aims of this experiment are: 1. Come up with a lab test that will predict how bad an allergic reaction will be to peanuts. 2. Find out what part of a peanut causes allergic reactions. 3. Come up with preventions that can block peanut allergies. 4. Find the strongest proteins in walnuts.