Clinical trials: Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 Following Intravenous Administration in Participants With Chronic Spontaneous Urticaria (CSU)
This is a Phase IIa, randomized, blinded, placebo controlled,Multiple-Ascending Dose study of BBT001 in adult patients with Chronic Spontaneous Urticaria.
- Trial name
- NCT07717905
- Testing
- BBT001
- Where
- 10 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Bambusa Therapeutics
Chronic Spontaneous Urticaria
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of Tacabrutideg (BGB-16673) in Adults With Chronic Spontaneous Urticaria and in Healthy Participants
This is a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of multiple-ascending doses of tacabrutideg in adults with chronic spontaneous urticaria (CSU) and in healthy participants.
- Trial name
- NCT07005713
- Testing
- Tacabrutideg
- Where
- 9 sites in China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines
Chronic Spontaneous Urticaria
A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines
The purpose of this study was to evaluate the safety and efficacy of ligelizumab in adult Japanese subjects with CSU, who remain symptomatic despite treatment with H1-antihistamines (AHs) at locally approved doses.
- Trial name
- NCT03907878
- Testing
- Ligelizumab
- Where
- 11 sites in Japan
- Volunteers
- 66 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Inducible Urticaria, Chronic Spontaneous Urticaria
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults
This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in…
- Trial name
- NCT07540910
- Testing
- EDP-978
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Chronic Spontaneous Urticaria
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3…
- Trial name
- NCT07256392
- Testing
- barzolvolimab, Standard of Care
- Where
- 201 sites in United States, Argentina and 28 more
- Volunteers
- 1,370 people
- Sponsor
- Celldex Therapeutics
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
Chronic Urticaria, Idiopathic, Hidradenitis
Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa
The study duration for an individual subject includes screening (14 days), the treatment period (28 days) and the observational follow-up period of 28 days, in total 70 days ± 6 days.
- Conditions
- Chronic Urticaria, Idiopathic, Hidradenitis, Hidradenitis Suppurativa
- Trial name
- NCT06555328
- Testing
- CSU lower dose treatment, CSU high dose treatment, CSU non responders IgE - high dose treatment
- Where
- 29 sites in United States, Bulgaria and 4 more
- Volunteers
- 73 people
- Sponsor
- InflaRx GmbH
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 Idiopathic Urticaria, Urticaria
The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic Urticaria
Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.
- Trial name
- NCT00346606
- Testing
- Denosin® and Xyzal®
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- Lotus Pharmaceutical
Allergic Disease, Chronic Spontaneous Urticaria
A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases
This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following a single subcutaneous injection of YH35324 in subjects with various allergic diseases.
- Conditions
- Allergic Disease, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria, Cold Urticaria
- Trial name
- NCT05960708
- Testing
- YH35324, Omalizumab
- Where
- 9 sites in South Korea
- Volunteers
- 30 people
- Sponsor
- Yuhan Corporation
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 Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients
This is a United States (US) based, prospective, non-interventional, provider-referral study to evaluate the real-world effectiveness and patient-centered outcomes of remibrutinib in chronic spontaneous urticaria (CSU) patients…
- Trial name
- RELIEF (NCT07408219)
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Novartis Pharmaceuticals
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 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
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
Urticaria
How Desloratadine (Clarinex, Aerius) Affects Quality of Life in Patients With Chronic Idiopathic Urticaria (Have Had Hives for 6 Weeks or Longer)(Study P02988)
The purpose of this study was to determine the effect of desloratadine treatment on quality of life, daytime functioning, quality of sleep, symptoms, and disease severity in patients who had hives for 6 weeks or longer.
- Trial name
- NCT00795158
- Testing
- desloratadine
- Volunteers
- 282 people
- Sponsor
- Organon and Co
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 Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria…
- Trial name
- NCT06865651
- Testing
- Remibrutinib
- Where
- 17 sites in United States, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
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-CSU2 (NCT06455202)
- Testing
- barzolvolimab
- Where
- 245 sites in United States, Australia and 20 more
- Volunteers
- 976 people
- Sponsor
- Celldex Therapeutics
Chronic Spontaneous Urticaria
Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria
This study is a multicenter, randomized, double-blind, parallel-group, positive-controlled phase III study to evaluate the therapeutic equivalence of SYN008 versus omalizumab for injection (Xolair®) in the treatment of CSU…
- Trial name
- NCT04944602
- Testing
- SYN008, Omalizumab for injection
- Volunteers
- 340 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.