Clinical trials: Chronic Spontaneous Urticaria (CSU)
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.
Healthy Study Participants, Chronic Spontaneous Urticaria
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants
The purpose of the study is to assess safety, tolerability and pharmacokinetics (PK) of oral UCB8600.
- Trial name
- NCT04444466
- Testing
- UCB8600
- Where
- Bulgaria
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Chronic Urticaria, Chronic Spontaneous Urticaria
Apremilast Added to Antihistamines in Chronic Urticaria
This study evaluates whether adding oral apremilast, a phosphodiesterase-4 inhibitor, to second-generation H1 antihistamines improves disease activity and quality of life in adults with chronic urticaria that is not controlled by…
- Conditions
- Chronic Urticaria, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria
- Trial name
- APREM-CU (NCT07850843)
- Testing
- Apremilast, Second-generation H1 antihistamine
- Where
- Pakistan
- Volunteers
- 86 people
- Sponsor
- Rashid Latif Medical College
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
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
Prospective, non-interventional study in patients with chronic spontaneous urticaria (CSU) where the treatment decision prior enrollment has been made to escalate/switch current treatment to remibrutinib.
- Trial name
- REASSERT (NCT07920315)
- Volunteers
- 578 people
- Sponsor
- Novartis Pharmaceuticals
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
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
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 (CSU)
Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with CSU.
- Trial name
- NCT07166211
- Testing
- CM512 injection
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Keymed Biosciences Co.Ltd
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 (CSU)
A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines
This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily [b.i.d.] by mouth [p.o.]) compared to dupilumab (600 mg loading dose administered…
- Trial name
- RECLAIM (NCT06868212)
- Testing
- Remibrutinib, Dupilumab
- Where
- 121 sites in United States
- Volunteers
- 409 people
- Sponsor
- Novartis Pharmaceuticals
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
Shotblocker® Use in Subcutaneous Injection
Aim: The aim of this study was to investigate the effect of subcutaneous injection with ShotBlocker® on patients with chronic spontaneous urticaria.
- Trial name
- NCT04210323
- Testing
- ShotBlocker®
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people
- Sponsor
- Saglik Bilimleri Universitesi
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 Idiopathic Urticaria, Atopy
Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)
This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or chronic hives.
- Trial name
- NCT00757562
- Testing
- desloratadine
- Volunteers
- 97 people
- Sponsor
- Organon and Co
Chronic Urticaria
T Cell Function in Chronic Idiopathic Urticaria
Chronic idiopathic urticaria (CIU) is a common form of chronic urticaria in which the cause is not detected after intensive clinical and laboratory investigation.In view of the current data, it was suggested that at least part of…
- Trial name
- NCT01425593
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- Meir Medical Center
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 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU)
This study will evaluate the efficacy and safety of different doses of EVO756 in adults with moderate to severe chronic spontaneous urticaria (CSU).
- Trial name
- NCT06873516
- Testing
- EVO756
- Where
- 53 sites in United States, Canada and 1 more
- Volunteers
- 182 people
- Sponsor
- Evommune, Inc.
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 (CSU)
Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria
Chronic spontaneous urticaria (CSU) is an immune-mediated skin disorder characterized by pruritic wheals and/or angioedema. This study aims to evaluate the relationship between diet-derived antioxidant capacity and oxidative…
- Trial name
- NCT07431658
- Where
- Turkey (Türkiye)
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Istanbul Training and Research Hospital