Clinical trials: Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria (CSU)
A Prospective, Single-centre, Observational Cohort Study on the Efficacy and Safety of Bacterial Lysate (OM-85) in Combination With Antihistamines for the Treatment of Chronic Spontaneous Urticaria (CSU)
A Prospective Clinical Study on the Efficacy and Safety of Bacterial Lysate (OM-85) Combined with Antihistamines in the Treatment of Chronic Spontaneous Urticaria (CSU): A Single-Centre, Observational, Cohort Study
- Trial name
- NCT07557888
- Where
- China
- Volunteers
- 132 people
- Sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Chronic Spontaneous Urticaria
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HS-10561 Capsule in Healthy Chinese Adults and Patients With Chronic Spontaneous Urticaria.
This is a randomized, double-blind, placebo-controlled phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HS-10561 capsule in healthy Chinese adults and patients with…
- Trial name
- NCT06864507
- Testing
- HS-10561
- Where
- China
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Chronic Spontaneous Urticaria
OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients
This trial assessed the efficacy of optimized re-treatment therapy with omalizumab (150mg or 300mg) after relapse, in participants with Chronic Spontaneous Urticaria who were clinically well-controlled following their first…
- Trial name
- OPTIMA (NCT02161562)
- Testing
- omalizumab
- Where
- 35 sites in Argentina, Brazil and 6 more
- Volunteers
- 314 people
- Sponsor
- Novartis Pharmaceuticals
Urticaria
Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria
The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic Idiopathic Urticaria.
- Trial name
- NCT00421109
- Testing
- Bilastine, Levocetirizine
- Where
- 50 sites in Argentina, Belgium and 5 more
- Volunteers
- 522 people
- Sponsor
- Faes Farma, S.A.
Chronic Spontaneous Urticaria
A Trial of HRS-3095 in Healthy Volunteers
The purpose of this study is to assess safety, PK, Pharmacodynamic profile of a single dose of HRS-3095 in healthy participants
- Trial name
- NCT07686484
- Testing
- HRS-3095
- Where
- Australia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Atridia Pty Ltd.
Chronic Spontaneous Urticaria
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.
- Trial name
- NCT02477332
- Testing
- QGE031, Omalizumab
- Where
- 82 sites in United States, Australia and 8 more
- Volunteers
- 382 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Idiopathic Urticaria
A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment
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
- NCT01287117
- Testing
- Omalizumab
- Where
- 66 sites in United States, Denmark and 6 more
- Volunteers
- 319 people
- Sponsor
- Genentech, Inc.
Chronic Spontaneous Urticaria
To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria
This study is a multicenter, randomized, double-blind, positive parallel controlled phase III clinical trial to compare efficacy, immunogenicity, pharmacokinetics, pharmacodynamics and safety of omalizumab α(CMAB007) and Xolair®…
- Trial name
- NCT06365879
- Testing
- CMAB007, Xolair
- Where
- China
- Volunteers
- 392 people
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Chronic Spontaneous Urticaria
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines
The purpose of this study was to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in…
- Trial name
- REMIX-1 (NCT05030311)
- Testing
- LOU064 25 mg (b.i.d), LOU064 25 mg (b.i.d) as a tablet.
- Where
- 112 sites in United States, Argentina and 17 more
- Volunteers
- 470 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China
This non-interventional, multi-center, prospective post-approval study aims to provide safety and effectiveness data of Xolair® in Chinese adolescents with Chronic Spontaneous Urticaria who remain symptomatic despite H1…
- Trial name
- NCT06053801
- Testing
- Xolair
- Where
- 10 sites in China
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria, Angioedema
Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy
This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.
- Trial name
- X-ACT (NCT01723072)
- Testing
- Omalizumab
- Where
- 25 sites in Germany
- Volunteers
- 91 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
A Study to Explore the Efficacy and Safety of HWH486 in Adults With Chronic Spontaneous Urticaria
This is a multicenter, randomized, double-bind and placebo-controlled phase IIa dose-finding study to assess the safety and efficacy of HWH486 in adults with chronic spontaneous urticaria (CSU).
- Trial name
- NCT06295302
- Testing
- HWH486
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Hubei Biological Medicine Industrial Technology Institute Co., Ltd.
Chronic Spontaneous Urticaria (CSU), Healthy Volunteers
Phase Ib, Randomized, Double-blind, Placebo-Controlled, Dose-Escalation Study of Alpha-0261 Tablets to Assess Safety and Tolerability in Patients With Chronic Spontaneous Urcaria (Part 1) and Food Effect in Healthy Adults (Part 2).
This is a randomized, double-blind, placebo-controlled phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Alpha-0261 Tablets in healthy Chinese adults and in patients with…
- Trial name
- NCT07684560
- Testing
- Alpha-0261
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AlphaMol Science Ltd. (Shanghai)
Chronic Idiopathic Urticaria
Etanercept for the Treatment of Chronic Urticaria
The purpose of this study is to evaluate the safety and efficacy of etanercept for patients with chronic idiopathic urticaria unresponsive to antihistamines.
- Trial name
- EtanerceptCIU (NCT01030120)
- Testing
- etanercept
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Utah
Chronic Idiopathic Urticaria
Three-month, Single-center Study to Identify Biomarkers/Response to Xolair Therapy in Chronic Idiopathic Urticaria
This is a single center, non-comparative exploratory study, to investigate the effect of omalizumab over a 3-month treatment period in adult (≥18 years) patients with chronic idiopathic urticaria who had remained symptomatic…
- Trial name
- NCT02814630
- Testing
- Xolair
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Asthma Inc Clinical Research Center
Urticaria
A Study of the Use of Methotrexate in the Treatment of Chronic Idiopathic Urticaria
The purpose of this study is to determine whether methotrexate produces significant improvement in chronic idiopathic urticaria, compared with placebo
- Trial name
- NCT00189878
- Testing
- Methotrexate (drug)
- Volunteers
- 3 people
- Sponsor
- Barnsley Hospital
Chronic Spontaneous Urticaria
Study to Evaluate the Efficacy, Safety, and Tolerability of Tirabrutinib in Participants With Antihistamine-Resistant Chronic Spontaneous Urticaria
The primary objective of this study is to evaluate the efficacy of tirabrutinib in reducing disease activity in participants with chronic spontaneous urticaria (CSU) with respect to change from baseline in urticaria activity…
- Trial name
- NCT04827589
- Testing
- Tirabrutinib
- Sponsor
- Gilead Sciences
Chronic Spontaneous Urticaria
Mepolizumab for the Treatment of Chronic Spontaneous Urticaria
This is an exploratory study designed to generate preliminary data in evaluating the efficacy of Nucala in the treatment of chronic spontaneous urticaria.
- Trial name
- NCT03494881
- Testing
- Nucala
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Mayo Clinic
Chronic Spontaneous Urticaria
Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU)
This study will evaluate the efficacy and safety of different doses of EVO756 in adults with moderate to severe chronic spontaneous urticaria (CSU).
- Trial name
- NCT06873516
- Testing
- EVO756
- Where
- 53 sites in United States, Canada and 1 more
- Volunteers
- 182 people
- Sponsor
- Evommune, Inc.
Chronic Spontaneous Urticaria
An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
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…
- Trial name
- NCT05513001
- Testing
- LOU064 (blinded), LOU064 (open label)
- Where
- 208 sites in United States, Argentina and 28 more
- Volunteers
- 696 people
- Sponsor
- Novartis Pharmaceuticals