Clinical trials: Chronic Spontaneous Urticaria
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.
Urticaria
Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria
Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria.
- Trial name
- NCT00525382
- Testing
- levocetirizine dihydrochloride
- Volunteers
- 134 people
- Sponsor
- UCB Pharma
Chronic Spontaneous Urticaria (CSU), Healthy Volunteers
Phase Ib, Randomized, Double-blind, Placebo-Controlled, Dose-Escalation Study of Alpha-0261 Tablets to Assess Safety and Tolerability in Patients With Chronic Spontaneous Urcaria (Part 1) and Food Effect in Healthy Adults (Part 2).
This is a randomized, double-blind, placebo-controlled phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Alpha-0261 Tablets in healthy Chinese adults and in patients with…
- Trial name
- NCT07684560
- Testing
- Alpha-0261
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AlphaMol Science Ltd. (Shanghai)
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
A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002) in adult subjects with H-1 antihistamine refractory chronic spontaneous…
- Trial name
- MAVERICK (NCT05528861)
- Testing
- Lirentelimab (AK002)
- Where
- 67 sites in United States, Germany and 1 more
- Volunteers
- 127 people
- Sponsor
- Allakos Inc.
Chronic Spontaneous Urticaria
OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients
This trial assessed the efficacy of optimized re-treatment therapy with omalizumab (150mg or 300mg) after relapse, in participants with Chronic Spontaneous Urticaria who were clinically well-controlled following their first…
- Trial name
- OPTIMA (NCT02161562)
- Testing
- omalizumab
- Where
- 35 sites in Argentina, Brazil and 6 more
- Volunteers
- 314 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of chronic spontaneous urticaria (CSU) that is not effectively treated by antihistamines which are…
- Trial name
- NCT07219615
- Testing
- Ritlecitinib 50 mg, Ritlecitinib 100 mg
- Where
- 77 sites in United States, Bulgaria and 8 more
- Volunteers
- 200 people
- Sponsor
- Pfizer
Chronic Spontaneous Urticaria
Global Managed Access Program Cohort for Remibrutinib in Adult Patients With Chronic Spontaneous Urticaria
The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide access to remibrutinib for adult patients with chronic spontaneous urticaria (CSU)
- Trial name
- NCT05170724
- Testing
- Remibrutinib
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
A Clinical Trial of HRS-3095 in Patients With Chronic Spontaneous Urticaria
The study is being conducted to evaluate the efficacy, and safety of HRS-3095 with Chronic Spontaneous in adults, and to explore the reasonable dosage of HRS-3095 for Chronic Spontaneous Urticaria.
- Trial name
- NCT07613866
- Testing
- HRS-3095 Tablet
- Where
- 2 sites in China
- Volunteers
- 190 people
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
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
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
Allergic Diseases, Chronic Spontaneous Urticaria (CSU)
Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
This study aims to evaluate the efficacy and safety of lesigercept in approximately 150 participants with CSU. By enrolling participants with an inadequate response to H1-antihistamines, including those previously treated with…
- Trial name
- CLEAR (NCT07415551)
- Testing
- Lesigercept
- Where
- 30 sites in Bulgaria, China and 2 more
- Volunteers
- 150 people
- Sponsor
- Yuhan Corporation
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.
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
Chronic Spontaneous Urticaria, Cholinergic Urticaria
Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria
The purpose of the study is to investigate the mechanism of action for ligelizumab (QGE031) treatment in patients with chronic urticaria. The study has two parts.
- Conditions
- Chronic Spontaneous Urticaria, Cholinergic Urticaria, Cold Urticaria
- Trial name
- MASTER (NCT04513548)
- Testing
- Ligelizumab
- Where
- Germany
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Chronic Idiopathic Urticaria
Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria
The study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221. In this study, safety profile of UB-221 and maximum tolerated dose (MTD) is to be investigated using sentinel dosing…
- Trial name
- NCT04175704
- Testing
- UB-221
- Volunteers
- 32 people
- Sponsor
- United BioPharma
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
A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.
- Trial name
- NCT04538794
- Testing
- CDX-0159, Normal Saline
- Where
- 14 sites in United States, Germany
- Volunteers
- 45 people
- Sponsor
- Celldex Therapeutics
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 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