Clinical trials: Chronic Spontaneous Urticaria
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 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 Idiopathic Urticaria
Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody
Study to determine the efficacy of benralizumab when compared to placebo in patients with chronic hives that do not respond to antihistamine treatment
- Trial name
- NCT03183024
- Testing
- benralizumab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Jonathan A. Bernstein, MD
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
A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China
This non-interventional, multi-center, prospective post-approval study aims to provide safety and effectiveness data of Xolair® in Chinese adolescents with Chronic Spontaneous Urticaria who remain symptomatic despite H1…
- Trial name
- NCT06053801
- Testing
- Xolair
- Where
- 10 sites in China
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
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 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 Spontaneous Urticaria
Mepolizumab for the Treatment of Chronic Spontaneous Urticaria
This is an exploratory study designed to generate preliminary data in evaluating the efficacy of Nucala in the treatment of chronic spontaneous urticaria.
- Trial name
- NCT03494881
- Testing
- Nucala
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Mayo Clinic
Chronic Spontaneous Urticaria, Recurrent Angioedema
Dupilumab in Chronic Spontaneous Urticaria
The purpose of this study is to assess the efficacy in reducing disease activity and safety of Dupilumab in adult patients with chronic spontaneous urticaria (CSU) who are symptomatic despite H1-antihistamine treatment.
- Trial name
- DUPICSU (NCT03749135)
- Testing
- Dupilumab
- Where
- 6 sites in Germany
- Volunteers
- 72 people
- Sponsor
- Charite University, Berlin, Germany
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 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 Idiopathic Urticaria
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the…
- Trial name
- NCT00866788
- Testing
- omalizumab, H1 antihistamines, Diphenhydramine
- Volunteers
- 90 people
- Sponsor
- Genentech, 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
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
Assessment of Serum Levels of Adenosine Deaminase and Immunoglobulin E in Patients With Chronic Spontaneous Urticaria
adenosine deaminase activity (ADA) has been reported to be elevated in various diseases such as psoriasis, acne and juvenile idiopathic arthritis.
- Trial name
- NCT05992987
- Testing
- Adenosine deaminase serum level, IgE antibodies serum level
- Volunteers
- 90 people
- Sponsor
- Sohag University
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
Non-autoreactive Chronic Spontaneous Urticaria, Autoimmune Chronic Spontaneous Urticaria
Profiling Urticaria for the Identification of Subtypes
The primary purpose of this study is to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria.
- Conditions
- Non-autoreactive Chronic Spontaneous Urticaria, Autoimmune Chronic Spontaneous Urticaria, Autoreactive, Non-autoimmune Chronic Spontaneous Urticaria
- Trial name
- PURIST (NCT01637116)
- Where
- Germany
- Volunteers
- 195 people
- Sponsor
- Marcus Maurer
Chronic Spontaneous Urticaria
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HS-10561 Capsule in Healthy Chinese Adults and Patients With Chronic Spontaneous Urticaria.
This is a randomized, double-blind, placebo-controlled phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HS-10561 capsule in healthy Chinese adults and patients with…
- Trial name
- NCT06864507
- Testing
- HS-10561
- Where
- China
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
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
Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)
This trial will be performed as a three-part dose escalating clinical trial where Parts 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled.
- Trial name
- BEACON (NCT06162728)
- Testing
- Briquilimab
- Where
- 23 sites in United States, Germany
- Volunteers
- 87 people
- Sponsor
- Jasper Therapeutics, Inc.