Clinical trials: Chronic Spontaneous Urticaria
Urticaria, Chronic Spontaneous Urticaria
Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria
This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.
- Conditions
- Urticaria, Chronic Spontaneous Urticaria, Chronic Idiopathic Urticaria, Hives
- Trial name
- NCT05936567
- Testing
- Povorcitinib
- Where
- 42 sites in United States, Germany and 1 more
- Volunteers
- 136 people
- Sponsor
- Incyte Corporation
Chronic Spontaneous Urticaria
A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.
The purpose of this study was to assess the effect of remibrutinib 25 mg twice a day (b.i.d.) open-label on Systolic Blood Pressure (SBP) measured as a change in 24-hour weighted average SBP from baseline to Week 4 assessed by…
- Trial name
- NCT05795153
- Testing
- LOU064
- Where
- 44 sites in United States, Argentina and 8 more
- Volunteers
- 144 people
- Sponsor
- Novartis Pharmaceuticals
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 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 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
Urticaria Chronic
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.
- Trial name
- NCT03632291
- Testing
- UB-221
- Where
- 2 sites in Taiwan
- Volunteers
- 15 people
- Sponsor
- United BioPharma
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
Chronic Spontaneous Urticaria
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to < 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by…
- Trial name
- NCT05677451
- Testing
- LOU064 (blinded)
- Where
- 49 sites in United States, Argentina and 15 more
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
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
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 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 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
A Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous Urticaria
The goal of this clinical trial is to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 injection in patients with chronic spontaneous urticaria (CSU) receiving background…
- Trial name
- NCT07875426
- Testing
- AK139
- Volunteers
- 201 people
- Sponsor
- Akeso
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
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 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
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
Global Managed Access Program Cohort for Ligelizumab in CSU
Global Cohort Managed Access Program (MAP) to provide access to ligelizumab (QGE031) for chronic spontaneous urticaria (CSU)
- Trial name
- NCT04903613
- Testing
- Ligelizumab
- 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 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 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.