Clinical trials: Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS-3095 oral administration in healthy subjects.
- Trial name
- NCT07230418
- Testing
- HRS-3095 Tablet
- Where
- China
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Chronic Spontaneous Urticaria
Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and…
- Trial name
- NCT04210843
- Testing
- Ligelizumab
- Where
- 273 sites in United States, Argentina and 43 more
- Volunteers
- 1,033 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Urticaria, Idiopathic
A Phase 2 Study of MG-K10 in Chronic Spontaneous Urticaria
This Phase 2 study evaluates the efficacy and safety of MG-K10 in participants with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines.
- Trial name
- NCT07838727
- Testing
- MG-K10 Injection
- Volunteers
- 60 people
- Sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
Chronic Spontaneous Urticaria (CSU), Allergic Asthma
ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
ROLL'YN-OMA is a real-world study in patients receiving standard biologic therapies who have been in control and/or remission of their disease for at least 3 months and whose physician has independently decided, within the…
- Trial name
- ROLL'YN-OMA (NCT07425639)
- Testing
- Omalizumab
- Where
- France
- Volunteers
- 225 people
- Sponsor
- Celltrion HealthCare France
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.
Urticaria
A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study
This is a Phase II, multicenter, open-label extension (OLE) study to evaluate the long-term safety and efficacy of fenebrutinib in participants with Chronic Spontaneous Urticaria (CSU) who have completed the treatment period in a…
- Trial name
- NCT03693625
- Testing
- GDC-0853
- Where
- 10 sites in United States
- Volunteers
- 31 people
- Sponsor
- Genentech, Inc.
Chronic Spontaneous Urticaria
Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria
The primary objective of this study is to evaluate the effect of tezepelumab on improvement in the Urticaria Activity Score over 7 days (UAS7).
- Trial name
- INCEPTION (NCT04833855)
- Testing
- Tezepelumab Dose 1, Tezepelumab Dose 2, Omalizumab
- Where
- 81 sites in United States, Canada and 8 more
- Volunteers
- 183 people
- Sponsor
- Amgen
Chronic Spontaneous Urticaria
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU
The main objective to assess the long-term safety and tolerability of LOU064 in patients with chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201 (NCT03926611)
- Trial name
- NCT04109313
- Testing
- LOU064
- Where
- 69 sites in United States, Argentina and 13 more
- Volunteers
- 229 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.
Urticaria Chronic
An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
This is a Phase 2b, outpatient, single-dose, randomized, double blind, placebo-controlled, three period crossover study that will consist of a screening period and three blinded treatment periods.
- Trial name
- NCT06927999
- Testing
- 0.5 mg epinephrine, 1 mg epinephrine
- Where
- 3 sites in United States, Germany
- Volunteers
- 42 people
- Sponsor
- ARS Pharmaceuticals, Inc.
Chronic Spontaneous Urticaria
A Phase III Study of 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 efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab…
- Trial name
- NCT03580356
- Testing
- Ligelizumab, Omalizumab
- Where
- 183 sites in United States, Argentina and 25 more
- Volunteers
- 1,078 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Participants, Chronic Spontaneous Urticaria
Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria
This is a Phase 1, randomized, double-blind, placebo-controlled, sequential, single- and multiple-ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of intravenous (IV) infusions…
- Trial name
- NCT06072157
- Testing
- AK006-IV, AK006-SC
- Where
- 25 sites in United States, Canada
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Allakos Inc.
Urticaria
A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of GDC-0853 compared with placebo in participants with Refractory Chronic Spontaneous Urticaria (CSU) already treated with anti-histamines.
- Trial name
- NCT03137069
- Testing
- GDC-0853
- Where
- 27 sites in United States, Canada and 1 more
- Volunteers
- 134 people
- Sponsor
- Genentech, Inc.
Chronic Spontaneous Urticaria
A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines
The purpose of this study was to evaluate the safety, tolerability and efficacy of remibrutinib (LOU064) in adult Japanese patients chronic spontaneous urticaria (CSU), who remain symptomatic despite treatment by H1-antihistamine…
- Trial name
- BISCUIT (NCT05048342)
- Testing
- LOU064
- Where
- 13 sites in Japan
- Volunteers
- 71 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
THB335-201 is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adults with CSU who remain symptomatic despite standard-of-care treatment.
- Trial name
- NCT07766499
- Testing
- THB335 Lower Dose, THB335 Higher Dose
- Volunteers
- 81 people
- Sponsor
- Calixis Inc.
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
Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients
Each patient will commence the study with a one month run-in period in which he/she will be administered individual patient Standard of Care :anti-histamines and steroids as needed plus placebo (olive oil).
- Trial name
- NCT04439955
- Testing
- CBD
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- Stero Biotechs Ltd.
Chronic Spontaneous Urticaria
A Study of Efficacy and Safety of TLL-018 in CSU Participants
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TLL-018 in Participants With Moderate-to-Severe Chronic Spontaneous Urticaria (CSU) With Inadequate Controll to…
- Trial name
- NCT06396026
- Testing
- TLL-018 tablets
- Where
- China
- Volunteers
- 440 people
- Sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
Chronic Spontaneous Urticaria
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)
This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of…
- Trial name
- NCT05526521
- Testing
- Dupilumab
- Where
- 15 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Sanofi
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