Clinical trials: Chronic Idiopathic 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 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 Idiopathic Urticaria, Chronic Idiopathic Pruritus
A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study.
- Conditions
- Chronic Idiopathic Urticaria, Chronic Idiopathic Pruritus, Lichen Planus, Lichen Simplex Chronicus
- Trial name
- NCT03858634
- Testing
- KPL-716
- Where
- 14 sites in United States
- Volunteers
- 58 people
- Sponsor
- Genentech, Inc.
Chronic Urticaria
Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria
This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.
- Trial name
- NCT00481676
- Testing
- Omalizumab 75-375 mg, Loratadine, Clemastine
- Where
- 11 sites in Germany
- Volunteers
- 49 people
- Sponsor
- Novartis
Asthma, Mastocytosis
Mast Cell Activation Test in Allergic Disease
Activation of mast cells in the immune system is known to cause allergic reactions sometimes with severe systemic symptoms. The investigators have recently developed a blood-based mast cell activation diagnostic test in which…
- Conditions
- Asthma, Mastocytosis, Mast Cell Activation Syndrome, Food Allergy
- Trial name
- NCT03406325
- Where
- Hong Kong
- Volunteers
- 19 people
- Sponsor
- Hong Kong Sanatorium & Hospital
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
Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who…
- Trial name
- NCT03328897
- Testing
- Omalizumab
- Where
- 27 sites in China
- Volunteers
- 418 people
- 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 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
Study for the Treatment of Chronic Idiopathic Urticaria With High Doses of AERIUS (Desloratadine) (Study P04849)
This study will investigate the effectiveness of desloratadine at doses higher (10 mg and 20 mg) than currently approved (5 mg) for the treatment of chronic idiopathic urticaria.
- Trial name
- NCT00536380
- Testing
- 5-mg Desloratadine, 10-mg Desloratadine, 20-mg Desloratadine
- Volunteers
- 314 people
- Sponsor
- Organon and Co
Chronic Urticaria
Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
The purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria…
- Trial name
- NCT04976192
- Testing
- TEV-45779, XOLAIR® Injection
- Where
- 9 sites in United States
- Volunteers
- 608 people
- Sponsor
- Teva Pharmaceuticals USA
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 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 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 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
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
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
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
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.
Systemic Juvenile Idiopathic Arthritis, Hereditary Periodic Fevers
A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies
The objective of this extension protocol is to collect safety data (serious and non-serious adverse events) and to provide continuous canakinumab to patients in France who completed study CACZ885G2301E1(NCT00891046), CACZ885G2306…
- Trial name
- NCT02334748
- Testing
- canakinumab
- Where
- 3 sites in France
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals