Chronic Spontaneous Urticaria (CSU)

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Review clinical trials related to Chronic Spontaneous Urticaria (CSU). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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. The main objectives are: To evaluate the rapid onset characteristics of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria. To evaluate the safety profile of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria. To evaluate the pharmacokinetic (PK) profile of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria. Participants will be randomly allocated at a 1:1:1 ratio to receive TLL-018 10 mg, TLL-018 20 mg, or placebo orally after meals.

Participants needed: 36
Trial details
Phase: Phase 1, Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Hangzhou Highlightll Pharmaceutical Co., LtdUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

Aged between 18 and 75. [+8]

Progressive or uncontrolled symptoms of renal, hepatic, hematologic, gastrointes... [+34]

Status: Recruiting

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 subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.

Participants needed: 400
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Novartis PharmaceuticalsUpdated: Jun 5, 2026Locations: 128
Eligibility criteria

Adults ≥ 18 years of age at the time of signing the informed consent [+7]

Previous use of remibrutinib or other bruton's tyrosine kinase (BTK) inhibitors [+7]

Status: Not yet recruiting

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

Participants needed: 132
Trial details
Age: 18-65Biological sex: AllType: ObservationalSponsor: The Fourth Affiliated Hospital of Zhejiang University School of MedicineUpdated: May 7, 2026Locations: 1
Eligibility criteria

The participants were fully informed of the purpose, procedure and risks of the... [+6]

Special types of urticaria: These primarily include physical urticaria (such as... [+10]

Status: Not yet recruiting

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 control of second-generation H1 antihistamines.

Participants needed: 226
Trial details
Phase: Phase 3Age: 12-75Biological sex: AllType: InterventionalSponsor: Shanghai Mabgeek Biotech.Co.LtdUpdated: Apr 22, 2026
Eligibility criteria

Aged ≥12 and ≤75 years, body weight ≥30 kg, voluntarily sign ICF. [+2]

Inducible urticaria (e.g., dermographism, cold, heat, cholinergic) or other chro... [+11]

Status: Recruiting

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

Participants needed: 344
Trial details
Phase: Phase 2, Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Beijing InnoCare Pharma Tech Co., Ltd.Updated: Apr 21, 2026Locations: 30
Eligibility criteria

1. Men and women aged 18 to 75 years. [+3]

1. Having the other medical conditions related to CSU or other skin diseases/con... [+3]

Status: Recruiting

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 omalizumab, this study is expected to provide evidence for the clinical utility of lesigercept and to further characterize its benefit-risk profile in the target participant population.

Participants needed: 150
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Yuhan CorporationUpdated: Apr 15, 2026Locations: 30
Eligibility criteria

Chronic spontaneous urticaria for ≥6 months, uncontrolled on 2nd-generation H1-a... [+3]

Any medical or lab findings suggesting risk of worsening co-existing conditions... [+4]

Status: Recruiting

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.

Participants needed: 48
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Keymed Biosciences Co.LtdUpdated: Apr 9, 2026Locations: 1
Eligibility criteria

Voluntarily sign the Informed Consent Form. [+5]

Not enough washing-out period for previous therapy. [+5]

Status: Recruiting

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 framework of a shared medical decision, to switch them to OMLYCLO®. The primary objective of this study is to evaluate the maintenance of this control and/or clinical remission 12 months after initiation of the biosimilar, and subsequently, patient satisfaction at 6 and 12 months.

Participants needed: 225
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Celltrion HealthCare FranceUpdated: Feb 23, 2026Locations: 1
Eligibility criteria

Be an adult (aged 18 years or older at the time of inclusion) receiving speciali... [+9]

Patients under guardianship or trusteeship, or otherwise deprived of liberty. [+3]

Status: Recruiting

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 anaphylaxis, patients with mastocytosis, patients with hereditary alpha tryptasemia, patients with X-linked agammaglobulinemia (XLA), and patients undergoing desensitization for venom or medication allergy.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: KU LeuvenUpdated: Jan 9, 2026Locations: 1
Eligibility criteria

CSU and type I allergic diseases (including anaphylaxis and desensitization), at... [+1]

Absence of informed consent [+1]

Status: Recruiting

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 subtype mycosis fungoides (MF), chronic spontaneous urticaria (CSU), and cutaneous lupus erythematosus (CLE) in daily practice. Data will be compared with data from healthy volunteers. This study is part of the larger NGID (Next Generation ImmunoDermatology) initiative, of which the main objective is to develop infrastructure that enables personalised patient care. The main questions the SKINERGY study aims to answer are: * Which biomarkers can discriminate between responders and non-responders to treatment in patients with AD, CLE, CSU, HS, MF, and PSO? * How do disease-related biomarkers in patients with AD, CLE, CSU, HS, MF, and PSO differ from those in healthy volunteers? * Which (multi-omics) biomarkers are associated with disease subtypes and predict response or non-response to (targeted) therapies in daily clinical practice? * How do biomarker profiles compare across different cohorts of patients with immune-mediated inflammatory skin diseases (AD, CLE, CSU, HS, MF, PSO) * How do biomarker levels change over time in response to treatment in these patient populations? * Which skin tissue biomarkers are associated with disease progression or treatment response? * How do the genomic profiles of patients differ across diseases or correlate with treatment outcomes? * Can additional imaging biomarkers enhance the characterization of disease profiles or treatment monitoring over time? Researchers will compare both differences beween patients within a disease group in different treatment arms, as well as patients within the same treatment arm. Additionally, biomarker profiles of patients with different diseases will be evaluated. These comparisons will be made to see if shared or distinct biomarker patterns exist across diseases and treatments, which could inform patient stratification, optimize therapeutic decision-making, and identify potential targets for future interventions. Participants will start medication according to national guidelines for the treatment of their inflammatory skin disease (AD: Cyclosporin A, anti-IL4/13, or anti-JAK; PSO: anti-TNF, anti-IL23, ani-IL17, anti-TYK2; HS: anti-TNF, anti-IL17; MF: CHLORM, TSC, PUVA-UV-B; CSU: anti-IgE, Cyclosporin A, anti-BTK\*; CLE: TSC, HCQ, MTX) \*once approved and reimbursed in the Netherlands Participants will: * Take the prescribed medication for their skin disease (in line with standard care in the Netherlands). * Visit the clinic for a study visit combined with their standard care appointment 3 times (baseline, month 3, and month 6. An additional 4th visit at month 12 is optional). * Fill in an online set of questionnaires from home, 3 times during the study period (an additional 4th time is optional). * Patients with CSU fill in the UAS7 (and if applicable the AAS7) daily for the study period.

Participants needed: 840
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Leiden University Medical CenterUpdated: Aug 19, 2025Locations: 8
Eligibility criteria

Able to understand and provide a written informed consent prior to any study pro... [+16]

Have any other relevant skin infection/disease in the treatment area other than... [+11]