Allergic Reaction

Researchers are evaluating the effectiveness, how the body processes the drug, and safety of remibrutinib compared to a placebo in adolescents aged 12 to less than 18 years with chronic spontaneous urticaria not well controlled by H1-antihistamines. The study also aims to collect long-term data on the drug's safety, tolerability, and effectiveness after 24 weeks of treatment and monitor safety up to three years after the last dose. The trial includes three periods: a 24-week double-blind, randomized core period where two-thirds of participants receive remibrutinib orally twice daily and one-third receive placebo, followed by an optional open-label extension where participants who completed the core period may receive remibrutinib for up to six cycles of 24 weeks or enter a treatment-free observational period for up to one year, with options to switch based on symptoms. A further optional long-term treatment-free follow-up lasts up to three years with limited visits. Participants will have about 10 site visits during the core period and between 3 and 15 visits during the extension depending on symptoms, plus annual follow-up visits and phone calls during the long-term follow-up. Researchers will assess changes in urticaria activity and severity scores at baseline and week 12, monitor drug levels in the blood, track adverse events, and evaluate quality of life. Safety and symptom control are closely monitored throughout all study periods.

Researchers are evaluating whether the supplement 5-hydroxytryptophan (5HTP) can improve breathing and reduce anxiety symptoms in children with mild to moderate allergic asthma. This phase 2 study aims to test if 5HTP reduces allergic lung responses, improves lung function measured by Forced Expiratory Volume at one second (FEV1), lowers blood eosinophil counts, and decreases anxiety and depression symptoms. The study is sponsored by Indiana University. Participants will receive either 5HTP or a placebo during two 28-day dosing periods separated by a 3-week washout phase. The 5HTP dose is based on weight: 50mg twice daily for those under 100 lbs, and 100mg twice daily for those over 100 lbs. The study uses a randomized, triple-blind crossover design, meaning participants switch from one treatment to the other during the study. Over about 12 weeks, participants will attend five study visits where lung function tests, blood samples to measure eosinophils, and anxiety/depression questionnaires will be completed. Researchers will monitor changes in lung function, blood markers, and mental health symptoms to evaluate the effects of 5HTP. Safety assessments will ensure participant well-being throughout the study period.

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.

Dentin hypersensitivity (DH) causes sharp, short pain from exposed dentin triggered by chemicals, temperature, or touch. It commonly affects older adults and varies widely in prevalence. This research evaluates the effectiveness of Casein phosphopeptide paste (CPP-ACP) alone or combined with a diode laser called Lasotronix in treating DH, as limited studies have explored this combination. The study involves four groups: one receiving CPP-ACP paste application only, one receiving diode laser therapy only, a third receiving both CPP-ACP and laser treatments, and a control group with no treatment. Lasotronix uses a 635nm wavelength laser designed for safe and effective bio-stimulation and photo-disinfection, while CPP-ACP paste aims to reduce pain by managing dentin sensitivity. Participants aged 25 to 65 with at least one sensitive, vital tooth without decay or defective restoration will be involved. They will undergo treatment and follow-up to assess dentin hypersensitivity over three months. Researchers will monitor pain levels and treatment effects, ensuring safety and adherence to the study protocol throughout the trial period.

Researchers are evaluating the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis (ABPA), a condition that often affects people with severe bronchial asthma. The study follows guidelines from ISHAM for ABPA diagnosis and treatment, aiming to understand how biologics can impact this condition. This is a prospective, multicenter observational cohort study sponsored by Qianfoshan Hospital. Participants receive standard medical treatment consisting of oral prednisone with a tapering dose over several weeks, with or without oral voriconazole. Some patients also receive biological agents combined with this standard therapy for at least four months, following GINA2025 guidelines. The biologics are given alongside existing asthma treatments, such as inhaled corticosteroids and long-acting beta-agonists. The study compares groups receiving biologics plus standard treatment versus standard treatment alone. During the study, researchers monitor participants for one to two years, assessing the number of exacerbations, hospitalizations, time to first exacerbation, remission rates, glucocorticoid use, asthma control, and various immune markers such as serum IgE and eosinophil counts. Safety and overall mortality are also tracked. This extensive follow-up includes measuring treatment responses at eight weeks and ongoing assessments to evaluate long-term effects and disease control.

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 child's 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 studying allergic asthma in children aged 6 to 17 years who identify as African American/Black or Caucasian/White. This randomized, double-blind, placebo-controlled crossover trial evaluates whether the antihistamine Levocetirizine (LTZ) improves asthma control in children with different histamine response types measured by Histamine Lontophoresis with Laser Doppler monitoring (HILD). The study aims to develop a biomarker that predicts therapeutic response and improve treatment decisions in pediatric asthma. Participants will be randomly assigned to receive either Levocetirizine dihydrochloride oral solution (2.5mg for children 6-11 years and 5mg for children over 11) or a placebo, both added to their current asthma therapy. The study includes screening, treatment periods, and assessments at baseline, 6 weeks after starting treatment, and after crossover to the alternate treatment. Each arm lasts approximately 6 weeks, with a total participation time of around 17 weeks. Children will undergo asthma control assessments using the Asthma Control Test (ACT) or Child-Asthma Control Test (C-ACT) depending on age. Other measures include asthma impairment, risk, and quality of life evaluations. Blood draws and HILD testing will be performed to monitor histamine response. The primary outcome is the change in asthma control after 6 weeks of treatment. Safety and adherence will be monitored throughout the 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.