Allergic Reaction

The purpose is to learn whether the over-the-counter amino acid supplement 5-hydroxytryptophan 5HTP, isolated from the plant Griffonia Simplifolia, can reduce allergic lung responses, improve lung function, and reduce anxiety and depression symptoms in children with allergic asthma. Participants will be randomly assigned to receive either 5HTP or a placebo and will later crossover to the other group. There are 5 study visits over about 12 weeks. The primary outcome is the change in FEV1. The investigators anticipate that 5HTP at the proposed doses will improve lung function as seen in preclinical studies using clinically relevant 5HTP. Other outcomes include blood eosinophil counts, eosinophil numbers in nasal fluid, lung inflammation, and changes in anxiety and depression scores measured using CES-DC and SCARED questionnaires. The study also examines whether 5HTP increases cortisol and prolactin without altering systemic plasma concentrations of 5HTP, serotonin, 5-hydroxyindoleacetic acid 5-HIAA, and dopamine. The results have the potential to influence approaches to improve lung function and asthma-associated anxiety and depression.

Researchers are evaluating the safety and effectiveness of SHR-1819 injection in treating adults with seasonal allergic rhinitis, a condition causing nasal allergy symptoms during pollen seasons. This phase II study is randomized, double-blind, and placebo-controlled, aiming to understand how the drug affects nasal symptoms and its behavior in the body. Participants are randomly assigned to receive one of two doses of SHR-1819 injection or a placebo. The study includes a treatment period lasting up to 4 weeks, where the impact on nasal symptoms is closely monitored. The trial also tracks safety by recording any adverse events for up to 12 weeks. Throughout the study, participants will complete daily symptom diaries and undergo assessments to measure changes in nasal symptoms using a total nasal symptom score. Researchers will collect data on how the drug is processed in the body and monitor participants safety. The total participation time may extend beyond the treatment period to capture all necessary outcome and safety information.

This prospective, multicenter, observational cohort study focuses on patients with allergic bronchopulmonary aspergillosis. The aim is to evaluate the efficacy and safety of biological agents used in these patients across multiple participating centers. The study observes how biological agents perform in the treatment of allergic bronchopulmonary aspergillosis while also assessing their safety.

This research observes children who took part in the TEMPO clinical trial during their first year of life to understand if their early feeding patterns affect the development of allergies or infections in childhood. The study follows these children up to 7.5 years to gather information on allergic symptoms, infections, and related medical care. It is an observational study without additional treatments or interventions. Participants complete self-administered digital questionnaires every three months using a smartphone, tablet, or computer. These questionnaires collect data on allergies, infections, medication use, medical device use, hospitalizations, and emergency room visits. The study is entirely virtual and decentralized, allowing families to participate remotely. Throughout the study, parents provide information via regular online questionnaires, helping researchers track their childs health over time. The main measurements include parent-reported symptoms, medication or device use, and healthcare visits related to allergies and infections. The study runs until March 2029 and includes children aged 3 to 10 years who completed the original TEMPO study.

Researchers are investigating the long-term outcomes of children and young people who completed an 18-month course of oral immunotherapy OIT for peanut, egg, or milk allergy. The study aims to compare changes in health-related quality of life HRQL up to 5-15 years after stopping OIT, focusing on participants who achieved remission and those who did not. This observational study involves participants from four earlier clinical trials related to OIT treatment for these allergies. Participants will attend one follow-up visit where several tests and evaluations will take place. These include a blood test to measure specific immunoglobulin E sIgE levels related to peanut, egg, or milk allergies, and a skin prick test to assess allergy status using various extracts like histamine, saline, house dust mite, rye grass, and the relevant food allergen. Blood collection may be via venipuncture or fingerprick depending on feasibility. Plasma and blood cells will be stored for future research. During the single study visit, participants will complete allergy questionnaires, and blood and skin tests will be conducted to gather data on immune markers and allergy status. Researchers will measure changes in HRQL and the incidence and severity of allergic reactions over the years following OIT. The visit is expected to last about two hours, and results will help understand the long-term effects of OIT on food allergy remission and quality of life.

Food Protein Induced Enterocolitis Syndrome FPIES is a type of non-IgE mediated food allergy that usually occurs in infancy and is often not well known by clinicians. The study aims to collect clinical information and allergy test results from children diagnosed with the acute form of FPIES and to observe their condition over three years. It seeks to better understand the evolution of FPIES, including atypical forms, with no prior prospective data available from France. Children diagnosed with acute FPIES will be followed in this national prospective study conducted at sixteen French centers. Allergy tests such as oral food challenges, skin prick tests, and IgE blood tests will be used for diagnosis and monitoring. Patients will be seen at an initial visit and then annually for up to three years. If tolerance to the offending food is not acquired, an oral food challenge will be performed in the hospital for confirmation. Participants will undergo yearly allergist visits for evaluation of symptoms and allergy testing. Researchers will measure the rate of tolerance acquisition to foods over one, two, and three years post-inclusion, as well as the progression to IgE sensitization and clinical IgE-mediated allergy. Additional outcomes include the presence of multiple FPIES episodes and related atopic conditions. The study will provide insights into the natural history and management of FPIES in children.

Researchers are evaluating GTX-B001, a humanized bispecific antibody targeting proteins on mast cells, in a first-in-human phase 1 study. The trial aims to assess the safety, pharmacokinetics, and pharmacodynamics of a single dose of GTX-B001. It includes both healthy adults and patients with chronic inducible urticaria, specifically cold urticaria and symptomatic dermographism, who remain symptomatic despite antihistamine treatment. This study is randomized, double-blind, and placebo-controlled. The study has two parts Part A enrolls up to 48 healthy participants in five ascending dose cohorts, and Part B enrolls 24 patients with chronic inducible urticaria in two ascending dose cohorts. Participants in both parts are randomly assigned to receive a single intravenous infusion of either GTX-B001 at various doses or a placebo of normal saline. The treatment is administered on Day 1 with follow-up visits extending up to 12 weeks after dosing. Participants will undergo up to 9 visits including screening over 4 weeks and follow-up assessments for 12 weeks post-treatment. Safety is monitored by tracking adverse events, while pharmacokinetics and pharmacodynamics of GTX-B001 are evaluated. For patients in Part B, preliminary efficacy on urticaria signs and symptoms is also assessed. The total participation period covers screening, treatment, and post-treatment monitoring to ensure thorough safety and response evaluation.

Researchers are conducting a phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate camoteskimab in adults with moderate-to-severe atopic dermatitis. The study includes both treatment-naive participants and those who have had an inadequate response to previous biologic therapies, aiming to assess the effectiveness and safety of camoteskimab for this condition. The study has two parts. In Part 1, lasting 24 weeks, participants are randomly assigned to receive one of three doses of camoteskimab or a placebo, all given by subcutaneous injection. In Part 2, which is an extension period, all participants will receive camoteskimab. This design allows comparison of different doses and the placebo before all receive the active treatment. Participants will undergo regular assessments including evaluation of eczema severity, body surface area affected, and itch intensity using specific scales like the Eczema Area and Severity Index EASI and Peak Pruritus Numerical Rating Scale PP-NRS. Researchers will monitor changes from baseline over 24 weeks. Safety and adherence will be closely followed throughout the study, which is planned to continue until April 2028.

Researchers are evaluating treatments for acute allergic bronchopulmonary aspergillosis ABPA, a condition complicating asthma. This trial aims to compare whether a combination of prednisolone and itraconazole reduces the rate of exacerbations within one year better than either prednisolone or itraconazole alone. The study follows 300 adults aged 18 years and older diagnosed with acute ABPA, assessing the impact of these treatments on disease flare-ups. Participants will be randomly assigned to one of three groups prednisolone alone, itraconazole alone, or a combination of both. Prednisolone is given orally in a tapering dose over four months, and itraconazole is given orally twice daily for four months with dose adjustments based on blood levels. The combination group receives both treatments simultaneously for the same duration. Therapeutic drug monitoring for itraconazole is performed at two weeks and two months. During the study, participants undergo baseline tests including demographic, immune, and imaging assessments. Follow-up visits occur every two months initially, then every four months for a total of five visits after treatment completion. Researchers track asthma and ABPA exacerbations over 12 months as the primary outcome. Secondary outcomes include immune response, time to first exacerbation, weight gain, blood sugar changes, and liver function. The study also monitors safety and treatment effects throughout the trial period.

Researchers are evaluating the real-world effectiveness and patient-centered outcomes of remibrutinib in adults with chronic spontaneous urticaria CSU, a condition characterized by spontaneous hives and itching. This prospective, non-interventional study compares patients starting remibrutinib treatment to those starting dupilumab, using validated patient reported outcome tools to measure results. The study is based in the United States and sponsored by Novartis Pharmaceuticals. Participants include adult patients diagnosed with CSU who have been prescribed remibrutinib or dupilumab and are expected to start treatment. The study observes two groups one receiving remibrutinib and the other dupilumab. The treatments are not administered by the study but are prescribed by healthcare providers as part of routine care. The study does not involve drug administration or placebo controls, focusing instead on real-world outcomes and patient satisfaction. During the study, participants use electronic devices to complete assessments including the Urticaria Control Test UCT-7 at baseline, week 1, and week 4 to measure symptom control. Treatment satisfaction is measured with the Treatment Satisfaction Questionnaire for Medication TSQM-9 at baseline and week 4. Researchers will monitor changes in these scores to understand treatment impact and patient satisfaction. The study requires participants to be able to read English and provide consent, with ongoing data collection continuing until the study ends in September 2026.