Chronic hives (chronic urticaria) clinical trials

Medical name: Chronic urticaria · Skin

52 trials are recruiting, according to ClinicalTrials.gov.

Checked against the registry on 5 October 2026. Listing a trial here is not a recommendation; taking part is voluntary and each study team decides who is eligible.

Recruiting · Phase 2 · Listed on Beacon

An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria

Ages 18 Years to 65 Years · 3 sites · ARS Pharmaceuticals, Inc.

Details and how to check if you qualify · NCT06927999 on ClinicalTrials.gov

Enrolling by invitation · Phase 2

Apremilast Added to Antihistamines in Chronic Urticaria

Ages 18 Years to 65 Years · 1 site · Rashid Latif Medical College

NCT07850843 on ClinicalTrials.gov

Not yet recruiting · Phase 2

A Phase 2 Study of MG-K10 in Chronic Spontaneous Urticaria

Ages 18 Years to 75 Years · 0 sites · Shanghai Mabgeek Biotech.Co.Ltd

NCT07838727 on ClinicalTrials.gov

Recruiting · Phase 3

Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks

Ages 18 Years to no maximum · 1 site · Novartis Pharmaceuticals

NCT07816328 on ClinicalTrials.gov

Not yet recruiting · Phase 2

A Study of Efficacy and Safety of TLL-018 in CSU Participants With Inadequate Response to 2nd-generation H1-AHs

Ages 18 Years to 75 Years · 0 sites · Hangzhou Highlightll Pharmaceutical Co., Ltd

NCT07764003 on ClinicalTrials.gov

Not yet recruiting · Phase 2

A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)

Ages 18 Years to 85 Years · 0 sites · Calixis Inc.

NCT07766499 on ClinicalTrials.gov

Not yet recruiting · Not applicable

A Randomised Controlled Trial of ePROM-Guided Flexible Scheduling in Dermatology

Ages 16 Years to no maximum · 0 sites · National University Hospital, Singapore

NCT07481019 on ClinicalTrials.gov

Not yet recruiting · Phase 1 / Phase 2

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

Ages 18 Years to 75 Years · 1 site · Hangzhou Highlightll Pharmaceutical Co., Ltd

NCT07665996 on ClinicalTrials.gov

Recruiting · Not applicable

Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)

Ages 18 Years to no maximum · 1 site · Novartis Pharmaceuticals

NCT07642557 on ClinicalTrials.gov

Recruiting · Early Phase 1

A Trial of HRS-3095 in Healthy Volunteers

Ages 18 Years to 55 Years · 1 site · Atridia Pty Ltd.

NCT07686484 on ClinicalTrials.gov

Not yet recruiting · Phase 1

Phase Ib, Randomized, Double-blind, Placebo-Controlled, Dose-Escalation Study of Alpha-0261 Tablets to Assess Safety and Tolerability in Patients With Chronic Spontaneous Urcaria (Part 1) and Food Effect in Healthy Adults (Part 2).

Ages 18 Years to 75 Years · 1 site · AlphaMol Science Ltd. (Shanghai)

NCT07684560 on ClinicalTrials.gov

Recruiting · Not applicable

Trial to Test the Efficacy of Using Magnetic Fields to Stimulate the Back to Treat Chronic Lower Back Pain.

Ages 18 Years to 64 Years · 1 site · Joe X. Zhang

NCT07652944 on ClinicalTrials.gov

Not yet recruiting · Phase 2

A Clinical Trial of HRS-3095 in Patients With Chronic Spontaneous Urticaria

Ages 18 Years to 70 Years · 2 sites · Chengdu Suncadia Medicine Co., Ltd.

NCT07613866 on ClinicalTrials.gov

Recruiting · Phase 1 / Phase 2

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 Following Intravenous Administration in Participants With Chronic Spontaneous Urticaria (CSU)

Ages 18 Years to 75 Years · 10 sites · Bambusa Therapeutics

NCT07717905 on ClinicalTrials.gov

Not yet recruiting · Not applicable

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)

Ages 18 Years to 65 Years · 1 site · The Fourth Affiliated Hospital of Zhejiang University School of Medicine

NCT07557888 on ClinicalTrials.gov

Not yet recruiting · Phase 3

Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.

Ages 18 Years to no maximum · 1 site · Cairo University

NCT07486583 on ClinicalTrials.gov

Not yet recruiting · Phase 3

A Study of MG-K10 in Chronic Spontaneous Urticaria

Ages 12 Years to 75 Years · 0 sites · Shanghai Mabgeek Biotech.Co.Ltd

NCT07546487 on ClinicalTrials.gov

Recruiting · Phase 1

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults

Ages 18 Years to 65 Years · 1 site · Enanta Pharmaceuticals, Inc

NCT07540910 on ClinicalTrials.gov

Recruiting · Phase 2

Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines

Ages 18 Years to 75 Years · 30 sites · Yuhan Corporation

NCT07415551 on ClinicalTrials.gov

Recruiting · Phase 3

Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.

Ages 18 Years to no maximum · 1 site · Jemincare

NCT07402213 on ClinicalTrials.gov

Recruiting · Not applicable

Circadian Rhythm Deregulation in Patients With CAPS

Ages 6 Years to no maximum · 6 sites · Hospices Civils de Lyon

NCT06544018 on ClinicalTrials.gov

Recruiting · Phase 2 / Phase 3

Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria

Ages 18 Years to 75 Years · 30 sites · Beijing InnoCare Pharma Tech Co., Ltd.

NCT07378527 on ClinicalTrials.gov

Recruiting · Not applicable

Remibrutinib in Real-world Clinical Practice

Ages 18 Years to no maximum · 1 site · Novartis Pharmaceuticals

NCT07358364 on ClinicalTrials.gov

Recruiting · Not applicable

Remibrutinib in Real-world Clinical Practice - a US Sub-study

Ages 18 Years to 100 Years · 1 site · Novartis Pharmaceuticals

NCT07358780 on ClinicalTrials.gov

Recruiting · Not applicable

A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients

Ages 18 Years to 100 Years · 1 site · Novartis Pharmaceuticals

NCT07408219 on ClinicalTrials.gov

Recruiting · Phase 3

A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)

Ages 18 Years to no maximum · 72 sites · Celldex Therapeutics

NCT07266402 on ClinicalTrials.gov

Enrolling by invitation · Not applicable

Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria

Ages 18 Years to 65 Years · 1 site · Istanbul Training and Research Hospital

NCT07431658 on ClinicalTrials.gov

Recruiting · Phase 2

Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)

Ages 18 Years to 75 Years · 1 site · Keymed Biosciences Co.Ltd

NCT07166211 on ClinicalTrials.gov

Enrolling by invitation · Phase 3

Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Ages 18 Years to no maximum · 131 sites · Celldex Therapeutics

NCT07256392 on ClinicalTrials.gov

Enrolling by invitation · Not applicable

Pseudoallergen-Free and Low-Histamine Diet in Adolescents With Chronic Spontaneous Urticaria

Ages 1 Year to 18 Years · 1 site · Istanbul University

NCT07632040 on ClinicalTrials.gov

Recruiting · Not applicable

Mediterranean and Low-Histamine Diets for Pediatric Chronic Spontaneous Urticaria

Ages 12 Years to 18 Years · 1 site · Saglik Bilimleri Universitesi

NCT07765979 on ClinicalTrials.gov

Recruiting · Phase 2

A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.

Ages 18 Years to no maximum · 69 sites · Pfizer

NCT07219615 on ClinicalTrials.gov

Recruiting · Phase 1

A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria

Ages 18 Years to 75 Years · 2 sites · Granular Therapeutics Limited

NCT07181369 on ClinicalTrials.gov

Recruiting · Not applicable

ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar

Ages 18 Years to no maximum · 1 site · Celltrion HealthCare France

NCT07425639 on ClinicalTrials.gov

Recruiting · Phase 1

Repeat PET/CT Imaging in People With CAPS and Anakinra-Induced Amyloidosis Using an Amyloid-Reactive Peptide to Measure Changes in Organ-Specific Amyloid Load

Ages 18 Years to 120 Years · 1 site · National Institute of Allergy and Infectious Diseases (NIAID)

NCT06974877 on ClinicalTrials.gov

Recruiting · Not applicable

SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)

Ages 18 Years to no maximum · 8 sites · Leiden University Medical Center

NCT07021495 on ClinicalTrials.gov

Recruiting · Phase 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of Tacabrutideg (BGB-16673) in Adults With Chronic Spontaneous Urticaria and in Healthy Participants

Ages 18 Years to 70 Years · 1 site · BeOne Medicines

NCT07005713 on ClinicalTrials.gov

Recruiting · Phase 3

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

Ages 18 Years to no maximum · 9 sites · Novartis Pharmaceuticals

NCT06868212 on ClinicalTrials.gov

Recruiting · Phase 2

Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria

Ages 18 Years to no maximum · 14 sites · Novartis Pharmaceuticals

NCT06865651 on ClinicalTrials.gov

Not yet recruiting · Phase 1 / Phase 2

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.

Ages 18 Years to 65 Years · 1 site · Jiangsu Hansoh Pharmaceutical Co., Ltd.

NCT06864507 on ClinicalTrials.gov

Recruiting · Not applicable

Ilaris NIS in Korea

Ages 2 Years to 100 Years · 1 site · Novartis Pharmaceuticals

NCT06838143 on ClinicalTrials.gov

Recruiting · Phase 2 / Phase 3

Interleukin-2 for Refractory Chronic Spontaneous Urticaria

Ages 18 Years to 74 Years · 1 site · Second Xiangya Hospital of Central South University

NCT06924762 on ClinicalTrials.gov

Not yet recruiting · Phase 2

Treatment Options for Chronic Urticaria

Ages 13 Years to 60 Years · 1 site · Sheikh Zayed Medical College

NCT06816784 on ClinicalTrials.gov

Recruiting · Not applicable

Deep Phenotyping of CIndU

Ages 18 Years to no maximum · 2 sites · Centre for Human Drug Research, Netherlands

NCT07359430 on ClinicalTrials.gov

Recruiting · Not applicable

Analysis of the Role of IgE Proteoforms in Health and Disease

Ages 18 Years to no maximum · 1 site · KU Leuven

NCT07328178 on ClinicalTrials.gov

Recruiting · Phase 2

Trial of JYB1904 in Chronic Spontaneous Urticaria.

Ages 18 Years to no maximum · 1 site · Jemincare

NCT06509334 on ClinicalTrials.gov

Recruiting · Phase 4

Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

Ages 18 Years to no maximum · 1 site · Simon Francis Thomsen

NCT05916937 on ClinicalTrials.gov

Not yet recruiting · Not applicable

Are Mast Cells Involved in Autoinflammatory Diseases

Ages 18 Years to no maximum · 1 site · Assistance Publique - Hôpitaux de Paris

NCT05292768 on ClinicalTrials.gov

Recruiting · Phase 2

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

Ages 18 Years to no maximum · 18 sites · Cogent Biosciences, Inc.

NCT04996875 on ClinicalTrials.gov

Recruiting · Not applicable

Deployment o the Multidisciplinary Prospective Cohort Imminent

Ages 18 Years to no maximum · 1 site · University Hospital, Lille

NCT04334031 on ClinicalTrials.gov

Recruiting · Not applicable

Characteristics and Management of Patients With Severe Chronic Spontaneous and/or Inducible Urticaria Refractory to Optimized Omalizumab Treatment: A French Multicenter Observational Study.

Ages 18 Years to 80 Years · 1 site · Centre Hospitalier Universitaire de Besancon

NCT07833696 on ClinicalTrials.gov

Recruiting · Not applicable

Natural History, Pathogenesis, and Outcome of Autoinflammatory Diseases (NOMID/CAPS, DIRA, CANDLE, SAVI, NLRC4-MAS, Still'S-like Diseases, and Other Undifferentiated Autoinflammatory Diseases)

Ages No minimum to 99 Years · 1 site · National Institute of Allergy and Infectious Diseases (NIAID)

NCT02974595 on ClinicalTrials.gov

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