Clinical trials: Chronic Spontaneous Urticaria, open to volunteers
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria…
- Trial name
- NCT06865651
- Testing
- Remibrutinib
- Where
- 17 sites in United States, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of chronic spontaneous urticaria (CSU) that is not effectively treated by antihistamines which are…
- Trial name
- NCT07219615
- Testing
- Ritlecitinib 50 mg, Ritlecitinib 100 mg
- Where
- 77 sites in United States, Bulgaria and 8 more
- Volunteers
- 200 people
- Sponsor
- Pfizer
Chronic Spontaneous Urticaria (CSU)
A Prospective, Single-centre, Observational Cohort Study on the Efficacy and Safety of Bacterial Lysate (OM-85) in Combination With Antihistamines for the Treatment of Chronic Spontaneous Urticaria (CSU)
A Prospective Clinical Study on the Efficacy and Safety of Bacterial Lysate (OM-85) Combined with Antihistamines in the Treatment of Chronic Spontaneous Urticaria (CSU): A Single-Centre, Observational, Cohort Study
- Trial name
- NCT07557888
- Where
- China
- Volunteers
- 132 people
- Sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
THB335-201 is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adults with CSU who remain symptomatic despite standard-of-care treatment.
- Trial name
- NCT07766499
- Testing
- THB335 Lower Dose, THB335 Higher Dose
- Where
- 15 sites in United States
- Volunteers
- 81 people
- Sponsor
- Calixis Inc.
Anaphylaxis, Mastocytosis
Analysis of the Role of IgE Proteoforms in Health and Disease
The goal of this observational study is to evaluate the role of IgE proteoforms in healthy volunteers and in patients with type I allergy, patients with chronic spontaneous urticaria, patients with a recent history of…
- Conditions
- Anaphylaxis, Mastocytosis, X-linked Agammaglobulinaemia, Venom Allergy
- Trial name
- IgE-PhD (NCT07328178)
- Testing
- Blood sample collection
- Where
- Belgium
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- KU Leuven
Chronic Spontaneous Urticaria
Remibrutinib in Real-world Clinical Practice - a US Sub-study
Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib.
- Trial name
- REASSERT (NCT07358780)
- Where
- United States
- Volunteers
- 505 people
- Sponsor
- Novartis Pharmaceuticals
Pediatric Chronic Spontaneous Urticaria
Pseudoallergen-Free and Low-Histamine Diet in Adolescents With Chronic Spontaneous Urticaria
The goal of this clinical trial is to learn whether a histamine- and pseudoallergen-restricted diet can help reduce symptoms in people with chronic urticaria.
- Trial name
- PAF-LH-CSU (NCT07632040)
- Testing
- Intervention Name: Low-histamine and pseudoallergen-free diet, General healthy eating advice
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- Istanbul University
Chronic Spontaneous Uriticaria
Interleukin-2 for Refractory Chronic Spontaneous Urticaria
The goal of this clinical trial is to learn if human interleukin-2 (IL-2) works to treat moderate to severe chronic spontaneous urticaria in adults who remain symptomatic despite oral antihistamine treatment (refractory CSU).
- Trial name
- ESIT-CSU (NCT06924762)
- Testing
- Human interleukin-2 (I) intramuscular injection
- Where
- China
- Volunteers
- 124 people
- Sponsor
- Second Xiangya Hospital of Central South University
Chronic Spontaneous Urticaria (CSU)
A Study of MG-K10 in Chronic Spontaneous Urticaria
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial aimed at evaluating the efficacy and safety of MG-K10 humanized monoclonal antibody injection in CSU trial participants with poor…
- Trial name
- NCT07546487
- Testing
- MG-K10 Humanized Monoclonal Antibody Injection
- Volunteers
- 226 people
- Sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
Chronic Spontaneous Urticaria
Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)
Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to escalate/switch current treatment to remibrutinib.
- Trial name
- NCT07642557
- Where
- Germany
- Volunteers
- 470 people
- Sponsor
- Novartis Pharmaceuticals
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 (CSU)
A Phase Ib/IIa Study Assessing the Rapid Onset Characteristics of TLL-018 for Moderate-to-Severe CSU With Inadequate Response to Second-Generation H1 Antihistamines
The goal of this clinical trial is to evaluate the rapid onset characteristics of TLL-018 in moderate-to-severe CSU with inadequate response to second-generation H1 antihistamines.
- Trial name
- NCT07665996
- Testing
- TLL-018
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
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
Urticaria Chronic
An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
This is a Phase 2b, outpatient, single-dose, randomized, double blind, placebo-controlled, three period crossover study that will consist of a screening period and three blinded treatment periods.
- Trial name
- NCT06927999
- Testing
- 0.5 mg epinephrine, 1 mg epinephrine
- Where
- 3 sites in United States, Germany
- Volunteers
- 42 people
- Sponsor
- ARS Pharmaceuticals, Inc.
Chronic Spontaneous Urticaria (CSU)
A Study of Efficacy and Safety of TLL-018 in CSU Participants With Inadequate Response to 2nd-generation H1-AHs
The goal of this clinical trial is to learn if different doses of TLL-018 works to treat in moderate-to-severe chronic spontaneous urticaria (CSU) participants . It will also learn about the safety of TLL-018.
- Trial name
- NCT07764003
- Testing
- TLL-018 tablets
- Volunteers
- 140 people
- Sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
Chronic Spontaneous Urticaria (CSU), Allergic Asthma
ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
ROLL'YN-OMA is a real-world study in patients receiving standard biologic therapies who have been in control and/or remission of their disease for at least 3 months and whose physician has independently decided, within the…
- Trial name
- ROLL'YN-OMA (NCT07425639)
- Testing
- Omalizumab
- Where
- France
- Volunteers
- 225 people
- Sponsor
- Celltrion HealthCare France
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
Remibrutinib in Real-world Clinical Practice
Prospective, multi-country, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to…
- Trial name
- REASSERT (NCT07358364)
- Where
- United States
- Volunteers
- 3,280 people
- Sponsor
- Novartis Pharmaceuticals