Urticaria (Hives)

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.

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.

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 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.

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 evaluating camoteskimab, a drug being studied in adults with moderate-to-severe atopic dermatitis. This phase 2b study is multicenter, randomized, double-blind, and placebo-controlled, aiming to assess the drug's effects compared to placebo. Participants include those who have not been treated before and those who have had an inadequate response to previous biologic therapies. The study has two parts: Part 1 is a 24-week period where participants are randomly assigned to one of four groups receiving one of three doses of camoteskimab or a placebo, all given by subcutaneous injection. In Part 2, an extension period, all participants will receive camoteskimab. This design allows researchers to compare the drug doses with placebo initially and then provide treatment to all participants. Participants will be involved for at least 24 weeks in the placebo-controlled phase and beyond during the extension. They will undergo assessments including the Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), and peak itch ratings. Researchers will measure changes in eczema severity, itch intensity, and skin condition over time. Safety and adherence will be monitored throughout the study period to evaluate the drug's effects and tolerability.

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.

The FARE Patient Registry is a prospective observational study focused on collecting detailed health and basic information about individuals living with food allergies. Its purpose is to encourage open sharing of de-identified data and to support participation in clinical trials, ultimately aiming to advance scientific discoveries related to food allergy causes and contributing factors. This registry does not involve any treatment or interventions but gathers real-world experiences from participants with food allergies. It serves as a platform for the food allergy community to contribute data that can help researchers understand the extent and etiology of food allergies. Participants provide their health information and experiences, which are stored in the registry for ongoing research use. The main outcome measured is the creation of a registry that characterizes food allergies and factors influencing their development. The study is observational, with no interventions, and participation can continue until the study end date in August 2027.

Researchers are evaluating the safety and effectiveness of baricitinib for treating severe or very severe alopecia areata, a condition causing hair loss, in children aged 6 to less than 18 years. This Phase 3 clinical trial aims to determine how well baricitinib works in this young population, with careful monitoring of outcomes related to hair regrowth and patient well-being. Participants will be randomly assigned to one of three groups: a high dose of baricitinib, a low dose of baricitinib, or a placebo. The study includes four periods: a 5-week screening phase to determine eligibility, a 36-week double-blind treatment period where participants receive their assigned treatment, an approximately 2-year long-term extension to observe longer-term effects, and a 4-week follow-up after treatment ends. Some participants may continue to receive treatment after the extension for up to 180 weeks. During the trial, children will undergo regular assessments including the Severity of Alopecia Tool (SALT) score to measure hair loss, patient-reported outcomes on scalp hair, eyebrow, and eyelash hair, as well as evaluations of anxiety, depression, and quality of life. Blood tests will monitor drug levels and immune response. Participants will be closely followed throughout the study periods to track changes and ensure safety, with the total participation lasting over two years depending on extension eligibility.

Researchers are conducting an observational study to understand how dupilumab is used and performs in real-world patients with chronic spontaneous urticaria (CSU). The study focuses on assessing dupilumab's effectiveness, safety, and usage patterns by collecting data from patients' medical records, routine clinical care, and patient-reported outcomes. This study will take place in the United States and aims to provide insights over a 24-month follow-up period. Participants in this study receive dupilumab treatment as prescribed by their own doctors as part of routine medical care, without any treatment administered by the study itself. After the decision to treat with dupilumab is made, patients can self-screen and enroll if eligible. The study does not interfere with treatment decisions but observes how the medication is used and its impact in everyday clinical settings over two years. During the study, participants will be monitored for various aspects including their disease activity, quality of life, work productivity, treatment satisfaction, and any hospitalizations related to CSU. Data will be collected at baseline and throughout up to 24 months. Safety events and medication use patterns will also be recorded. Participants' information is gathered through medical files and questionnaires, with follow-up continuing until the study ends, withdrawal, loss to follow-up, or death.