Clinical trials: Chronic Spontaneous Urticaria
Chronic Idiopathic Urticaria
A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
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
- NCT01292473
- Testing
- Omalizumab
- Where
- 61 sites in United States, Denmark and 6 more
- Volunteers
- 323 people
- Sponsor
- Genentech, Inc.
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
Chronic Spontaneous Urticaria
Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001
An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study.
- Trial name
- NCT06577116
- Testing
- AK006 IV
- Where
- 14 sites in United States, Canada
- Volunteers
- 29 people
- Sponsor
- Allakos Inc.
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 Spontaneous Urticaria
A Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of UB-221 IV Infusion as an add-on Therapy in Patients With Chronic Spontaneous Urticaria
This is a phase II, double-blind, randomized, parallel group, placebo-controlled study to evaluate the pharmacodynamics, pharmacokinetics, efficacy, and safety of 2-dose UB-221 IV infusion as an add-on therapy in patients with…
- Trial name
- NCT05298215
- Testing
- UB-221, sterile saline solution
- Where
- Taiwan
- Volunteers
- 25 people
- Sponsor
- United BioPharma
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 Idiopathic Urticaria
CUTE (Chronic Urticaria Treatment Evaluation)
A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment
- Trial name
- NCT00264303
- Testing
- Levocetirizine, Desloratadine
- Where
- 80 sites in Belgium, France and 7 more
- Volunteers
- 886 people
- Sponsor
- UCB Pharma
Chronic Spontaneous Urticaria
A Study of Single Dose of LP-003 in Healthy Adult Subjects
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy subjects.
- Trial name
- NCT06604949
- Testing
- LP-003 200mg
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Longbio Pharma
Chronic Spontaneous Urticaria
Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every…
- Trial name
- NCT06042478
- Testing
- Remibrutinib, Omalizumab
- Where
- 110 sites in Argentina, Brazil and 21 more
- Volunteers
- 470 people
- Sponsor
- Novartis Pharmaceuticals
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
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.
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
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
Chronic Spontaneous Urticaria
Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)
Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to escalate/switch current treatment to remibrutinib.
- Trial name
- NCT07642557
- Where
- Germany
- Volunteers
- 470 people
- Sponsor
- Novartis Pharmaceuticals
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
Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU)
The goal of this clinical trial is to study patients with chronic spontaneous urticaria. The main question it aims to answer is the efficacy and safety of histamine human immunoglobulin (ShuYangMinNing) in the treatment of…
- Trial name
- NCT06250400
- Testing
- human histaglobulin, Loratadine 10 Mg
- Volunteers
- 252 people
- Sponsor
- Hangzhou Grand Biologic Pharmaceutical, Inc.
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
Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks
The purpose of this open-label study is to assess the efficacy and safety of a novel treatment algorithm for sequencing remibrutinib and omalizumab in the treatment of adult participants with chronic spontaneous urticaria (CSU)…
- Trial name
- NCT07816328
- Testing
- Remibrutinib, Omalizumab
- Where
- 5 sites in Hong Kong, Japan and 1 more
- Volunteers
- 382 people
- Sponsor
- Novartis Pharmaceuticals
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
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