Clinical trials: Chronic Spontaneous Urticaria (CSU)
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 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 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
Rhinitis, Urticaria
Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED)
The objective of this non-interventional study is to evaluate the safety of Aerius syrup in pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria.
- Trial name
- NCT00723736
- Testing
- Desloratadine
- Volunteers
- 100 people
- Sponsor
- Organon and Co
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
- 182 sites in United States, Argentina and 28 more
- Volunteers
- 1,370 people
- Sponsor
- Celldex Therapeutics
Chronic Spontaneous Urticaria
Tranexamic Acid and Spontaneous Chronic Urticaria
Spontaneous chronic urticaria (UCS) is a disease that affects 1% of the general population with a potentially severe impact on quality of life.
- Trial name
- TACUS (NCT03789422)
- Testing
- association of levocetirizine and tranexamic acid, Levocetirizine only
- Where
- France
- Volunteers
- 80 people
- Sponsor
- University Hospital, Grenoble
Chronic Spontaneous Urticaria
Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.
- Trial name
- NCT04404023
- Testing
- UB-221
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- UBP Greater China (Shanghai) Co., Ltd
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.
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
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
Chronic Spontaneous Urticaria
Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria (CSU), defined by the persistence of daily or almost daily urticaria over 6 weeks, affects 0.5% to 1% of the general population. In more than half of the cases, it lasts more than 2 years.
- Trial name
- LEVURE PLUS (NCT02372604)
- Testing
- Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration., Levocetirizine, (as levocetirizine dihydrochloride) 20 mg ( then 5 mg) per day. Oral administration.
- Volunteers
- 15 people
- Sponsor
- Hospices Civils de Lyon
Chronic Idiopathic Urticaria
Efficacy and Safety of Chemoattractant Receptor-homologous Molecule Expressed on T Helper Type 2 (CRTh2) Antagonist AZD1981 in Chronic Idiopathic Urticaria (CIU) Antihistamines
The investigators are recruiting for a chronic hives study. This research is being done to test whether an investigational drug called AstraZeneca drug (AZD)1981 may be helpful for treating people with Chronic Idiopathic…
- Trial name
- NCT02031679
- Testing
- AZD1981
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Johns Hopkins University
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 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
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
Type 2 Inflammatory Disorders
Compassionate Use or Expanded Access of Dupilumab
Provide Compassionate Use or Expanded Access of Dupilumab
- Trial name
- NCT04776694
- Testing
- Dupilumab
- Sponsor
- Regeneron 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.
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 Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Characteristics and Management of Patients With Severe Chronic Spontaneous and/or Inducible Urticaria Refractory to Optimized Omalizumab Treatment: A French Multicenter Observational Study.
The study is sponsored by the University Hospital of Besancon under the coordination of Dr. Julie Castagna from the Department of Dermatology and Allergology.
- Trial name
- OMADROP (NCT07833696)
- Testing
- drug effect
- Where
- France
- Volunteers
- 73 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Urticaria, Chronic Idiopathic Urticaria
A Comparison of Aerius Continuous Treatment Versus Aerius PRN for Chronic Idiopathic Urticaria (Study P03147)
This double-blind pilot study was conducted to establish the best way of using desloratadine treatment to protect quality of life of chronic idiopathic urticaria (CIU) patients, after an initial 4-weeks of daily treatment…
- Trial name
- ATTITUD (NCT00783354)
- Testing
- desloratadine
- Volunteers
- 129 people
- Sponsor
- Organon and Co