Clinical trials: Chronic Spontaneous Urticaria (CSU)
Chronic Idiopathic Urticaria, Urticaria
The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic Urticaria
Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.
- Trial name
- NCT00346606
- Testing
- Denosin® and Xyzal®
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- Lotus Pharmaceutical
Chronic Spontaneous Urticaria
Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
- Trial name
- NCT07402213
- Testing
- JYB1904
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Jemincare
Chronic Spontaneous Urticaria
Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)
Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to escalate/switch current treatment to remibrutinib.
- Trial name
- NCT07642557
- Where
- Germany
- Volunteers
- 470 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Idiopathic Urticaria
A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy of omalizumab administered subcutaneously as an add-on therapy for the treatment…
- Trial name
- NCT01264939
- Testing
- Omalizumab, H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist, Diphenhydramine
- Where
- 73 sites in United States, Australia and 6 more
- Volunteers
- 336 people
- Sponsor
- Genentech, Inc.
Chronic Spontaneous Urticaria
Improving Health and Wellbeing for People Diagnosed With Chronic Spontaneous Urticaria (CSU)
This study aims to investigate the influence of psychosocial factors on Chronic Spontaneous Urticaria (CSU). Preliminary research suggests a potential link between stress and the experience of CSU symptoms.
- Trial name
- NCT06108869
- Testing
- ABT Online Programme, Delayed Control group
- Where
- Ireland
- Volunteers
- 100 people
- Sponsor
- Royal College of Surgeons, Ireland
Chronic Spontaneous Urticaria
A Study to Compare Digital Disease Monitoring of Patients With csU (Telemedicine to Face-to-Face Visits) in Germany
This is a multicenter, non-randomized, non-interventional two-cohort study with prospective collection of primary data on monitoring of Chronic spontaneous urticaria (CSU) patients by telemedicine or F2F visits in routine…
- Trial name
- DigiMoc (NCT06991608)
- Testing
- Collection of patient data
- Where
- 20 sites in Germany
- Volunteers
- 116 people
- Sponsor
- Novartis Pharmaceuticals
Urticaria
A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48 weeks for treatment of H1 antihistamine…
- Trial name
- NCT02392624
- Testing
- Omalizumab
- Where
- 40 sites in United States
- Volunteers
- 206 people
- Sponsor
- Genentech, Inc.
Chronic Urticaria
Methotrexate in the Treatment of Chronic Idiopathic Urticaria
Chronic urticaria is defined by urticarial lesions persisting at 6 weeks. The cause is not found in about 75% of cases (chronic idiopathic urticaria). The gold standard treatment consists of anti-H1 molecules.
- Trial name
- MUCIS (NCT01960283)
- Testing
- Methotrexate (Novatrex ®) + anti-H1
- Where
- 11 sites in France
- Volunteers
- 83 people
- Sponsor
- University Hospital, Tours
Chronic Spontaneous Urticaria
Global Managed Access Program Cohort for Remibrutinib in Adult Patients With Chronic Spontaneous Urticaria
The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide access to remibrutinib for adult patients with chronic spontaneous urticaria (CSU)
- Trial name
- NCT05170724
- Testing
- Remibrutinib
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines
This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by…
- Trial name
- NCT03926611
- Testing
- LOU064 Arm 1, LOU064 Arm 2, LOU064 Arm 3
- Where
- 82 sites in United States, Argentina and 15 more
- Volunteers
- 311 people
- Sponsor
- Novartis Pharmaceuticals
Urticaria Chronic
Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)
This is a Phase IV, single-site study that will examine blood cells or tissue obtained from CIU ( chronic idiopathic Urticaria) patients receiving open-label treatment with omalizumab at the current FDA-approved dose of 300…
- Trial name
- NCT03111628
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Johns Hopkins University
Spontaneous Urticaria, Chronic
Real-life Study of How to Intensify Treatment With Xolair (OMALIZUMAB) in Chronic Spontaneous Urticaria
This is an observational study whose main objective is to estimate the frequency of patients benefiting from an intensification of AOM treatment at 3 months.
- Trial name
- INTENXO (NCT04583475)
- Where
- France
- Volunteers
- 163 people
- Sponsor
- University Hospital, Lille
CHRONIC SPONTANEOUS URTICARIA
Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment
Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.
- Trial name
- SUNRISE (NCT02550106)
- Testing
- OMALIZUMAB
- Where
- 29 sites in France
- Volunteers
- 136 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Idiopathic Urticaria
A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment…
- Trial name
- NCT01292473
- Testing
- Omalizumab
- Where
- 61 sites in United States, Denmark and 6 more
- Volunteers
- 323 people
- Sponsor
- Genentech, Inc.
Chronic Spontaneous Urticaria
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of Tacabrutideg (BGB-16673) in Adults With Chronic Spontaneous Urticaria and in Healthy Participants
This is a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of multiple-ascending doses of tacabrutideg in adults with chronic spontaneous urticaria (CSU) and in healthy participants.
- Trial name
- NCT07005713
- Testing
- Tacabrutideg
- Where
- 9 sites in China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines
Chronic Spontaneous Urticaria
A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines
The purpose of this study was to evaluate the safety and efficacy of ligelizumab in adult Japanese subjects with CSU, who remain symptomatic despite treatment with H1-antihistamines (AHs) at locally approved doses.
- Trial name
- NCT03907878
- Testing
- Ligelizumab
- Where
- 11 sites in Japan
- Volunteers
- 66 people
- Sponsor
- Novartis Pharmaceuticals
Anaphylaxis, Mastocytosis
Analysis of the Role of IgE Proteoforms in Health and Disease
The goal of this observational study is to evaluate the role of IgE proteoforms in healthy volunteers and in patients with type I allergy, patients with chronic spontaneous urticaria, patients with a recent history of…
- Conditions
- Anaphylaxis, Mastocytosis, X-linked Agammaglobulinaemia, Venom Allergy
- Trial name
- IgE-PhD (NCT07328178)
- Testing
- Blood sample collection
- Where
- Belgium
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- KU Leuven
Chronic Spontaneous Urticaria (CSU)
Efficacy of Bilastine Up-dosing (40 mg ) Versus Combination of Bilastine (20 mg )With Levocitirizine (5 mg) in the Treatment of Chronic Spontaneous Urticaria
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.
- Trial name
- NCT07365683
- Testing
- tab bilastine 20 mg, tab bilastine 20 mg + tab levocetrizine 5 mg
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Derma Techno Pakistan
Chronic Urticaria
A Real-World Study of Omalizumab Treatment Patterns in Chronic Urticaria Patients in China
The aim of this study was to characterize the real-world treatment patterns of omalizumab among adult patients with chronic urticaria in China using data from a regional electronic healthcare (rEHR) database.
- Trial name
- NCT07450170
- Where
- China
- Volunteers
- 3,485 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria
The purpose of this study is to evaluate the efficacy and safety of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines
- Trial name
- NCT05335499
- Testing
- TAS5315 Dose 1, TAS5315 Dose 2, TAS5315 Dose 3
- Where
- 12 sites in Japan
- Volunteers
- 126 people
- Sponsor
- Taiho Pharmaceutical Co., Ltd.