Clinical trials: Chronic Spontaneous Urticaria (CSU)
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
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
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)
This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of…
- Trial name
- NCT05526521
- Testing
- Dupilumab
- Where
- 15 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Sanofi
Chronic Spontaneous Urticaria
Global Managed Access Program Cohort for Ligelizumab in CSU
Global Cohort Managed Access Program (MAP) to provide access to ligelizumab (QGE031) for chronic spontaneous urticaria (CSU)
- Trial name
- NCT04903613
- Testing
- Ligelizumab
- 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
Healthy Participants, Chronic Spontaneous Urticaria
Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria
This is a Phase 1, randomized, double-blind, placebo-controlled, sequential, single- and multiple-ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of intravenous (IV) infusions…
- Trial name
- NCT06072157
- Testing
- AK006-IV, AK006-SC
- Where
- 25 sites in United States, Canada
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Allakos Inc.
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
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
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 Idiopathic Urticaria
Efficacy Study of Canakinumab to Treat Urticaria
Evaluation whether canakinumab leads to improvement of urticaria
- Trial name
- URTICANA (NCT01635127)
- Testing
- Canakinumab
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- University of Zurich
Chronic Spontaneous Urticaria
STOP CSUA: phySical acTivity, mOod and sleeP in Chronic Spontaneous Urticaria and Angioedema
Chronic spontaneous urticaria and angioedema (CSUA) is a disease of the skin characterised by hives, swellings or both that last longer than 6 weeks.
- Trial name
- STOP CSUA (NCT05169645)
- Testing
- Physical activity monitoring - Symptom monitoring
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- St. James's Hospital, Ireland
Urticaria, Respiratory Allergic Diseases
Autologous Serum Skin Test and Serum IL-18 Levels in Chronic Idiopathic Urticaria and Respiratory Allergic Diseases
One of the proposed mechanisms in CU is autoimmunity. It was shown by a positive response to autologous serum skin test (ASST)in almost half of chronic urticaria (CU) patients. IL-18 also play a role in autoimmune disorders.
- Trial name
- NCT01091402
- Testing
- autologous serum skin test, serum IL-18
- Where
- Turkey (Türkiye)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Eskisehir Osmangazi University
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 (CSU), Hidradenitis Suppurativa (HS)
SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
The goal of this observational study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma…
- Conditions
- Chronic Spontaneous Urticaria (CSU), Hidradenitis Suppurativa (HS), Psoriasis (PsO), Atopic Dermatitis (AD)
- Trial name
- SKINERGY (NCT07021495)
- Where
- 8 sites in Netherlands
- Volunteers
- 840 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Chronic Urticaria, Idiopathic
A Phase 2 Study of MG-K10 in Chronic Spontaneous Urticaria
This Phase 2 study evaluates the efficacy and safety of MG-K10 in participants with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines.
- Trial name
- NCT07838727
- Testing
- MG-K10 Injection
- Volunteers
- 60 people
- Sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
Chronic Spontaneous Urticaria (CSU)
Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria
The purpose of this study is to compare the efficacy and safety of ICP-332 in moderate to severe chronic spontaneous urticaria subjects inadequately controlled by second generation H1-antihistamines
- Trial name
- NCT07378527
- Testing
- ICP-332 Tablets
- Where
- 30 sites in China
- Volunteers
- 344 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Chronic Spontaneous Urticaria
A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.
The purpose of this study was to assess the effect of remibrutinib 25 mg twice a day (b.i.d.) open-label on Systolic Blood Pressure (SBP) measured as a change in 24-hour weighted average SBP from baseline to Week 4 assessed by…
- Trial name
- NCT05795153
- Testing
- LOU064
- Where
- 44 sites in United States, Argentina and 8 more
- Volunteers
- 144 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, Parasitic Disease
Frequency of Parasite Infestation in Patients With Chronic Spontaneous Urticaria
The goal of this study is to describe the prevalence and the type of parasite in patients with a chronic spontaneous urticaria as well as to describe the associations between parasitic disease and the characteristics of the…
- Trial name
- NCT04314999
- Testing
- Examination of stool samples
- Where
- Switzerland
- Volunteers
- 57 people
- Sponsor
- University Hospital, Basel, Switzerland
Urticaria Chronic
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.
- Trial name
- NCT03632291
- Testing
- UB-221
- Where
- 2 sites in Taiwan
- Volunteers
- 15 people
- Sponsor
- United BioPharma