Clinical trials: Chronic Spontaneous Urticaria (CSU)
Chronic Idiopathic Urticaria
Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria
The study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221. In this study, safety profile of UB-221 and maximum tolerated dose (MTD) is to be investigated using sentinel dosing…
- Trial name
- NCT04175704
- Testing
- UB-221
- Volunteers
- 32 people
- Sponsor
- United BioPharma
Chronic Spontaneous Urticaria
Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine
The first phase of this study will be a parallel, 12-week treatment, Phase 2, double-blind, 4 arm study to assess the safety and effectiveness of 3 oral doses of SAR444671 (rilzabrutinib), i.e.
- Trial name
- RILECSU (NCT05107115)
- Testing
- rilzabrutinib
- Where
- 128 sites in Argentina, Canada and 11 more
- Volunteers
- 160 people
- Sponsor
- Sanofi
Chronic Idiopathic Urticaria, Atopy
Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)
This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or chronic hives.
- Trial name
- NCT00757562
- Testing
- desloratadine
- Volunteers
- 97 people
- Sponsor
- Organon and Co
Chronic Spontaneous Urticaria
A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002) in adult subjects with H-1 antihistamine refractory chronic spontaneous…
- Trial name
- MAVERICK (NCT05528861)
- Testing
- Lirentelimab (AK002)
- Where
- 67 sites in United States, Germany and 1 more
- Volunteers
- 127 people
- Sponsor
- Allakos Inc.
Chronic Inducible Urticaria, Chronic Spontaneous Urticaria
Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)
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…
- Trial name
- NCT06931405
- Testing
- BLU-808
- Where
- 47 sites in United States, Denmark and 4 more
- Volunteers
- 105 people
- Sponsor
- Blueprint Medicines Corporation
Chronic Spontaneous Urticaria
Trial of JYB1904 in Chronic Spontaneous Urticaria.
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
- Trial name
- NCT06509334
- Testing
- JYB1904, Omalizumab
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Jemincare
Chronic Urticaria, Chronic Idiopathic Urticaria
Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients
The aim of this study is to investigate the pathophysiological mechanism of omalizumab in patients with documented chronic urticaria who have complaints under standard antihistamine treatment.
- Conditions
- Chronic Urticaria, Chronic Idiopathic Urticaria, Chronic Spontaneous Urticaria
- Trial name
- NCT01803763
- Testing
- Omalizumab (Xolair)
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Chronic Spontaneous Urticaria (CSU)
Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria
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…
- Trial name
- NCT07431658
- Where
- Turkey (Türkiye)
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Istanbul Training and Research Hospital
Chronic Spontaneous Urticaria
A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)
The purpose of this study is to investigate the use of benralizumab is effective in the treatment of chronic spontaneous urticaria (CSU) who are symptomatic despite the use of antihistamines.
- Trial name
- ARROYO (NCT04612725)
- Testing
- Benralizumab
- Where
- 40 sites in United States, Bulgaria and 5 more
- Volunteers
- 159 people
- Sponsor
- AstraZeneca
Chronic Spontaneous Urticaria (CSU)
A Study of MG-K10 in Chronic Spontaneous Urticaria
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial aimed at evaluating the efficacy and safety of MG-K10 humanized monoclonal antibody injection in CSU trial participants with poor…
- Trial name
- NCT07546487
- Testing
- MG-K10 Humanized Monoclonal Antibody Injection
- Volunteers
- 226 people
- Sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
Chronic Spontaneous Urticaria (CSU)
Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with CSU.
- Trial name
- NCT07166211
- Testing
- CM512 injection
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Keymed Biosciences Co.Ltd
Chronic Spontaneous Urticaria
A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria
This is a decentralized study designed to describe the real-world effectiveness, safety, and patterns of use of dupilumab in patients with chronic spontaneous urticaria (CSU).
- Trial name
- DEDICATION (NCT07316114)
- Testing
- Dupilumab
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Sanofi
Chronic Urticaria, Idiopathic
Molecular Endotypes of Chronic Idiopathic Urticaria
This study plans to learn more about why some people with Chronic Idiopathic Urticaria (CIU) respond to treatment with omalizumab (Xolair).
- Trial name
- NCT04774315
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Chronic Spontaneous Urticaria, Cholinergic Urticaria
Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria
The purpose of the study is to investigate the mechanism of action for ligelizumab (QGE031) treatment in patients with chronic urticaria. The study has two parts.
- Conditions
- Chronic Spontaneous Urticaria, Cholinergic Urticaria, Cold Urticaria
- Trial name
- MASTER (NCT04513548)
- Testing
- Ligelizumab
- Where
- Germany
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria (CSU)
A Phase Ib/IIa Study Assessing the Rapid Onset Characteristics of TLL-018 for Moderate-to-Severe CSU With Inadequate Response to Second-Generation H1 Antihistamines
The goal of this clinical trial is to evaluate the rapid onset characteristics of TLL-018 in moderate-to-severe CSU with inadequate response to second-generation H1 antihistamines.
- Trial name
- NCT07665996
- Testing
- TLL-018
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
Chronic Spontaneous Urticaria
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria
- Trial name
- CALM-CSU (NCT06077773)
- Testing
- Oral EP262
- Where
- 48 sites in United States, Canada and 4 more
- Volunteers
- 113 people
- Sponsor
- Escient Pharmaceuticals, Inc
Urticaria
Efficacy and Safety of Rupatadine 10 and 20 Mg in Chronic Idiopathic Urticaria
· To evaluate the efficacy of rupatadine 10 and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo.
- Trial name
- NCT00199251
- Testing
- RUPATADINE
- Volunteers
- 300 people
- Sponsor
- J. Uriach and Company
Chronic Urticaria
Efficacy and Safety Study of Omalizumab (Xolair®) to Treat Chronic Urticaria
Chronic urticaria can be defined as the occurrence of widespread daily or almost daily wheals for at least 6 weeks, which may be accompanied by angioedema.
- Trial name
- NCT01713725
- Testing
- Omalizumab
- Where
- 4 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
Chronic Spontaneous Urticaria
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
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…
- Trial name
- EMBARQ-CSU1 (NCT06445023)
- Testing
- barzolvolimab
- Where
- 235 sites in United States, Argentina and 19 more
- Volunteers
- 963 people
- Sponsor
- Celldex Therapeutics
Chronic Idiopathic Urticaria
Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria
The study is designed to assess the efficacy and safety of monthly injections of Omalizumab 150 mg for 3 consecutive months, in patients with chronic idiopathic urticaria, unresponsive to convetional therapy by antihistamins or…
- Trial name
- NCT02166151
- Testing
- Omalizimab
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Rabin Medical Center