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NCT07408219
This is a United States (US) based, prospective, non-interventional, provider-referral study to evaluate the real-world effectiveness and patient-centered outcomes of remibrutinib in chronic spontaneous urticaria (CSU) patients using validated patient reported outcome (PRO) tools.
NCT07256392
The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials. This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.
NCT00852943
Background: * Mast cells are responsible for most symptoms of allergic reactions. In some allergic diseases, it is unusually easy to cause mast cells to release their contents and cause allergic reactions. In other cases, mast cells grow abnormally and, in rare cases, can result in tumors. Mast cells also control other parts of the immune system. * Understanding why mast cells behave abnormally in allergic diseases is important to finding better ways for diagnosing and treating these potentially life-threatening disorders. Objectives: * To screen mast cells at the genetic and functional levels to characterize abnormalities, identify mutations, detect carrier states, and/or develop therapies for such disorders. * To create a library of information about inherited diseases of mast cell homeostasis and activation, including piebaldism (problems with skin and hair pigmentation), anaphylaxis (severe allergic reaction), allergies, asthma, atopic dermatitis (eczema), allergic rhinitis ( hay fever ), food allergies, urticaria/angioedema (hives/swelling), immunodeficiency diseases, and autoimmune diseases. Eligibility: * Patients between the ages of 1 and 80 years who have been referred by a physician and are known to have or be suspected of having an inherited disorder of mast cells, in particular patients (and their relatives) with piebaldism, allergies, or anaphylaxis that is not caused by allergies. Design: * Study population will consist of up to 1000 participants in a 5-year period. One third of the study population will consist of patients; the other two thirds will consist of biological relatives. * Evaluation is limited to testing on blood specimens; no treatment will be provided. * Clinical and research laboratory evaluations of patients will include the following: * Clinical evaluation and previous laboratory tests as documented in outside medical records by health care providers. A standard questionnaire will also be administered at the time of subject enrollment. * Blood collection for clinical laboratory testing, tailored to each subject s clinical evaluation where appropriate (5 ml). * Blood collection for research laboratory testing, tailored to each subject s clinical evaluation including genetic screening and assessment of mast cell growth and functioning and storage of additional frozen blood specimens for future studies (up to an additional 30 ml). * Evaluations of blood relatives will include the following: * Clinical evaluation as documented from outside medical records by health care providers and administration of a standard questionnaire. * Blood collection where indicated for diagnostic or research purposes. * After 12 consecutive months on the study, results from initial evaluation will be reviewed. Subjects with findings deemed to be of continued interest will be contacted and invited to remain as active participants to this protocol for another year, provided that they renew their consent to participate.
NCT07358364
Prospective, multi-country, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.
NCT06455202
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
NCT07486583
To evaluate the efficacy of Autologous Whole Blood Therapy versus conventional treatment using fourfold dose of antihistamines in Autologus serum skin test (ASST) positive and negative Chronic Idiopathic Urticaria (CIU) patients and suggest its possible mechanism of action.
NCT07481019
The goal of this clinical trial is to evaluate whether an electronic patient-reported outcome measure (ePROM)-guided flexible scheduling system can improve outpatient clinic resource utilisation in patients attending dermatology outpatient clinics for routine follow-up. The main questions it aims to answer are: * Does the intervention reduce the number of actualised outpatient visits over 12 months compared with standard fixed scheduling? * Does the intervention group achieve higher adherence to monthly ePROM monitoring, as measured by the proportion of completed ePROM submissions?
NCT05936567
This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.
NCT05513001
The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 core studies. This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.
NCT06445023
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
NCT07431658
Chronic spontaneous urticaria (CSU) is an immune-mediated skin disorder characterized by pruritic wheals and/or angioedema. This study aims to evaluate the relationship between diet-derived antioxidant capacity and oxidative stress with CSU presence, disease activity, and response to omalizumab. Adults with active CSU and age/BMI-matched healthy controls will provide non-consecutive 3-day dietary records (two weekdays and one weekend day). Dietary antioxidant capacity will be calculated using ORAC metrics via BeBiS software. Oxidative stress biomarkers (total oxidant status, total antioxidant status, oxidative stress index, malondialdehyde, and advanced oxidation protein products) will be measured from venous blood samples. CSU disease activity will be assessed using UAS7 and UCT, along with an urticaria quality of life questionnaire. In CSU patients who receive omalizumab as clinically indicated, assessments will be repeated after 3 months to evaluate treatment response and associated changes in diet and oxidative stress markers.
NCT06544018
Circadian rhythms are characterized by the physiology's adaptation to the alternation of day and night, enabling to adapt to the environment. These rhythms are generated by a molecular clock within each cell. At the molecular level, the circadian clock is based on a complex system of cell-autonomous transcription loops. These exert positive and negative feedback on themselves, generating cyclic transcriptional activity. * In the main loop, the BMAL1 transcription factor links with CLOCK or NPAS2 ( (Neuronal PAS Domain Protein 2) to activate transcription of per1,2 and 3 and cryptochrome (cry1 and cry2), which in turn repress BMAL1/CLOCK1 transcriptional activity.. The BMAL1/CLOCK complex also activates transcription of numerous target genes (per and cry, Rev-erb, etc.).. * other secondary loops refine the function of the first. Recent studies suggest that many aspects of innate immunity are controlled by circadian rhythm through inhibition of NLRP3 inflammasome activation. Nevertheless, the regulation of the NLRP3 inflammasome by the circadian clock has yet to be elucidated. Inflammasomes are molecular platforms that control caspase-1 activation and consequently the maturation of precursors of (interleukine) IL-1β, pro-IL-18, a pro-inflammatory cytokine. Since its discovery, its functions have been widely characterized as part of the innate immune response as a sensor of pathogens and danger signals (extracellular ATP (Adenosine triphosphate), atmospheric pollutants). NLRP3 (nucleotide-binding domain LRR (leucin-rich repeat ) and pyrin-containing receptor 3) has been described for its genetic association with dominant monogenic hereditary syndromes characterized by recurrent systemic inflammatory episodes in the absence of any infection or autoimmune disease, known as CAPS (cryopyrin-associated periodic syndrome) or cryopyrinopathies which is a continuum of diseases ranging from a moderate to the most severe form of the syndrome: familial cold urticaria syndrome, Muckle-Wells syndrome (MWS), and CINCA/NOMID syndrome. Interestingly, patients with Muckle-Wells syndrome show a circadian pattern of symptoms, with a recurrent, predominantly vesperal fever peak lasting a few hours, and extreme fatigue on a daily basis. However, a molecular link between the circadian clock and CAPS pathology remains to be determined. The aim of this protocol is to identify circadian rhythm dysregulation in patients with CAPS confirmed by genetic analysis of NLRP3, to demonstrate a link between circadian clock and CAPS syndrome, and to identify circadian clock regulatory pathways.
NCT07266402
The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.
NCT07428941
This study aims to determine if an artificial intelligence (AI) medical device can help primary care doctors more accurately identify and manage various skin conditions. Skin issues are a frequent reason for doctor visits, but differences in expertise between general practitioners and specialists can sometimes lead to misdiagnoses or unnecessary referrals. The researchers hypothesized that the information provided by the AI device would increase the true diagnostic accuracy of primary care practitioners for multiple dermatological conditions. To test this, the study followed a prospective, self-controlled design where each participating doctor served as their own comparison. During the study, 9 primary care physicians evaluated 30 clinical images representing a variety of skin pathologies. For each image, the doctors followed a two-step process: * First, they provided a diagnosis based only on the image and the patient's medical history. * Second, they were shown the AI's analysis-including the top 5 suggested diagnoses and confidence levels-and asked to provide a final diagnosis. The study also investigated if the AI could help doctors decide whether a patient truly needs a referral to a specialist or if the condition could be handled remotely via teledermatology. The primary question was whether using this AI support would significantly increase the number of correct diagnoses made by primary care doctors and lead to more efficient patient care.
NCT06736262
Phase 2, open-label, extension study to evaluate the long-term safety, clinical activity, and pharmacodynamics of briquilimab in participants previously enrolled in a Jasper sponsored CU clinical trial.
NCT06931405
This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of BLU-808, a wild type KIT inhibitor, in participants with CIndU (Part A) or CSU (Part B).
NCT07402213
This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
NCT07005713
This study is a Phase 1b, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of multiple-ascending doses of BGB-16673 in adults with chronic spontaneous urticaria (CSU).
NCT07181369
This is a first-in-human study aimed at determining the safety of a single dose of GTX-B001 in healthy participants and in people with chronic inducible urticaria.
NCT07365683
This study aims to compare the effectiveness and safety of two commonly used antihistamines, bilastine 20 mg and levocetirizine 5 mg, in patients diagnosed with chronic urticaria. Chronic urticaria is a skin condition characterized by recurrent itchy wheals that significantly affect quality of life. Eligible participants will be randomly assigned to receive either bilastine or levocetirizine for a defined treatment period. The severity of symptoms, improvement in itching and wheals, and any adverse effects will be assessed during follow-up visits. The results of this study will help determine which treatment provides better symptom control with fewer side effects in patients with chronic urticaria.