Clinical trials: Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria
A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating…
- Trial name
- NCT03580369
- Testing
- Ligelizumab, Omalizumab
- Where
- 161 sites in United States, Argentina and 27 more
- Volunteers
- 1,072 people
- Sponsor
- Novartis Pharmaceuticals
Asthma, Mastocytosis
Mast Cell Activation Test in Allergic Disease
Activation of mast cells in the immune system is known to cause allergic reactions sometimes with severe systemic symptoms. The investigators have recently developed a blood-based mast cell activation diagnostic test in which…
- Conditions
- Asthma, Mastocytosis, Mast Cell Activation Syndrome, Food Allergy
- Trial name
- NCT03406325
- Where
- Hong Kong
- Volunteers
- 19 people
- Sponsor
- Hong Kong Sanatorium & Hospital
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 Spontaneous Urticaria
To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic despite H1 antihistamine…
- Trial name
- omalizumab (NCT04426890)
- Testing
- CT-P39, EU-approved Xolair
- Where
- Poland
- Volunteers
- 634 people
- Sponsor
- Celltrion
Chronic Spontaneous Urticaria
Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU)
This clinical study was designed to evaluate the pharmacokinetics, safety and efficacy of ligelizumab in children from 12 to < 18 years of age, with chronic spontaneous urticaria (CSU).
- Trial name
- NCT03437278
- Testing
- Ligelizumab
- Where
- 20 sites in Argentina, Belgium and 8 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Chronic Spontaneous Urticaria
A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
The reason for this study is to see if the study drug LY3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU) and that are not controlled with…
- Trial name
- NCT04159701
- Testing
- LY3454738
- Where
- 25 sites in United States, Germany and 1 more
- Volunteers
- 52 people
- Sponsor
- Eli Lilly and Company
Urticaria
Study to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GSK2646264
This First Time in Human (FTIH) study, which will be performed in three parts, is designed to investigate the safety, local tolerability, pharmacokinetics and pharmacodynamics after single and repeat topical applications of up to…
- Trial name
- NCT02424799
- Testing
- GSK2646264 0.5% topical cream, GSK2646264 1% topical cream
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 34 people
- Sponsor
- GlaxoSmithKline
Chronic Spontaneous Urticaria
A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201
- Trial name
- NCT02649218
- Testing
- Ligelizumab
- Where
- 67 sites in United States, Australia and 8 more
- Volunteers
- 226 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Idiopathic Urticaria
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the…
- Trial name
- NCT00866788
- Testing
- omalizumab, H1 antihistamines, Diphenhydramine
- Volunteers
- 90 people
- Sponsor
- Genentech, Inc.
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
Chronic Urticaria
Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria
This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.
- Trial name
- NCT01701583
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Colorado, Denver
Rhinitis, Urticaria
Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria
Eligible patients will be prescribed Desloratadine 1 tablet of 5 mg once daily. Patients will be asked to follow-up for a final visit after 14 days (Day 15) where the safety, tolerability and clinical efficacy will be measured.
- Trial name
- Aerius (NCT00724698)
- Testing
- Desloratadine
- Volunteers
- 3,011 people
- Sponsor
- Organon and Co
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 25 mg b.i.d. in adult patients suffering from chronic spontaneous urticaria (CSU) inadequately controlled by second generation…
- Trial name
- REMIX-2 (NCT05032157)
- Testing
- LOU064 (blinded), LOU064 (open-label)
- Where
- 122 sites in United States, Austria and 16 more
- Volunteers
- 455 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 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, 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 Urticaria
Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
The purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria…
- Trial name
- NCT04976192
- Testing
- TEV-45779, XOLAIR® Injection
- Where
- 9 sites in United States
- Volunteers
- 608 people
- Sponsor
- Teva Pharmaceuticals USA
Chronic Idiopathic Urticaria
Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment
The study is designed to explore the mode of action for omalizumab therapy in patients with chronic idiopathic urticaria.
- Trial name
- NCT01599637
- Testing
- IGE025
- Where
- 4 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals