44 completed, 8 terminated, 6 recruiting, 4 active not recruiting. 69 Phase 1, 17 Phase 2.
By phase and status
Phase Trials Status Phase 1 69 Completed 44 , Terminated 8 , Recruiting 6 , Active not recruiting 4 , Not yet recruiting 3 , Unknown 2 , Withdrawn 2 Phase 2 17 Completed 5 , Terminated 4 , Active not recruiting 3 , Not yet recruiting 2 , Recruiting 2 , Withdrawn 1
Follow Urticaria: new trials by email Literature Review of Urticaria trials Research Report on Urticaria
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All 69 trials
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
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 TLL-018, Placebo - Chronic Spontaneous Urticaria (CSU) Phase 1 / Phase 2 Not yet recruiting 36 2026-08-15 2026-08-24 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). Alpha-0261, Placebo - Chronic Spontaneous Urticaria (CSU), Healthy Volunteers Phase 1 Not yet recruiting 48 2026-07-01 2026-07-06 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) BBT001, Placebo - Chronic Spontaneous Urticaria Phase 1 / Phase 2 Recruiting 48 2026-06-29 2026-07-22 A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults EDP-978, Placebo - Chronic Inducible Urticaria, Chronic Spontaneous Urticaria Phase 1 Recruiting 98 2026-04-01 2026-04-21 A Phase 1 Study of Cizutamig in IgE Mediated Diseases Cizutamig - IgE-Mediated Hypersensitivity, IgE Mediated Food Allergy Phase 1 Withdrawn 2026-04-01 2026-07-22 Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS) JTE-162 - Cryopyrin-associated Periodic Syndromes (CAPS) Phase 1 Completed 5 2026-02-02 2026-10-09 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes HRS-3095 Tablet, HRS-3095 Placebo Tablet - Chronic Spontaneous Urticaria Phase 1 Completed 82 2025-11-10 2026-06-12 A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria GTX-B001, Normal Saline - Healthy Subjects, Cold Urticaria Phase 1 Recruiting 72 2025-10-06 2026-10-30 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 124I AT-01 - Cryopyrin-Associated Periodic Syndromes, Amyloidosis Phase 1 Recruiting 30 2025-09-10 2026-05-19 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 Tacabrutideg, Placebo - Chronic Spontaneous Urticaria Phase 1 Recruiting 58 2025-07-19 2026-09-09 To Compare and Evaluate the Oral Bioavailability of Bilastine 20 mg Orally Dispersible Tablet With That of Bilaxten (Bilastine) 20 mg Orally Dispersible Tablet in Healthy, Adult, Human Subjects Under Fasting Conditions Bilastine oral dispersible tablets, Bilaxten oral dispersible tablets - Allergic Rhino-Conjunctivitis, Urticaria Phase 1 Completed 42 2025-04-30 2025-06-29 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. HS-10561, Placebo - Chronic Spontaneous Urticaria Phase 1 / Phase 2 Not yet recruiting 150 2025-03-31 2025-03-07 Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients Deucrictibant XR tablet, Placebo comparator to XR tablet, Deucrictibant 20 mg capsule - Hereditary Angioedema (HAE), Angioedema Phase 1 / Phase 2 Recruiting 10 2025-03-10 2025-07-02 A Study of Single Dose of LP-003 in Healthy Adult Subjects LP-003 200mg, Placebo - Chronic Spontaneous Urticaria Phase 1 Active not recruiting 12 2024-10-23 2025-12-18 Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001 AK006 IV - Chronic Spontaneous Urticaria Phase 1 Completed 29 2024-08-28 2025-08-27 A Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines Briquilimab - Chronic Inducible Urticaria Phase 1 / Phase 2 Terminated 27 2024-03-18 2025-10-08 Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria UB-221 - Chronic Idiopathic Urticaria Phase 1 Unknown 32 2023-12-30 2022-10-03 Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers UB-221 - Chronic Spontaneous Urticaria Phase 1 Unknown 15 2023-12-01 2022-05-18 Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU) Briquilimab, Placebo - Chronic Spontaneous Urticaria Phase 1 / Phase 2 Completed 87 2023-11-29 2026-08-06 Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria Oral EP262 - Chronic Inducible Urticaria Phase 1 Completed 33 2023-08-30 2024-12-09
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Narrower conditions Chronic Urticaria (23) · Angioedemas, Hereditary (22) · Cryopyrin-Associated Periodic Syndromes (7) · Angioedema (6) · Chronic Inducible Urticaria (6) · Pruritus (6) · Skin Diseases (6) · Hypersensitivity (5) · Immune System Diseases (5) · Cold Urticaria (4) · Rhinitis, Allergic (4) · Skin Diseases, Vascular (4) · Dermatitis, Atopic (3) · Hypersensitivity, Immediate (3)
Broader conditions Skin and Connective Tissue Diseases (69) · Hypersensitivity, Immediate (66) · Skin Diseases, Vascular (65) · Hypersensitivity (64) · Immune System Diseases (64) · Skin Diseases (63) · Pathological Conditions, Signs and Symptoms (36) · Disease Attributes (33) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (32) · Pathologic Processes (32) · Chronic Disease (31) · Genetic Diseases, Inborn (30) · Cardiovascular Diseases (24) · Vascular Diseases (24)
Interventions berotralstat (4) · Interleukin 1 Receptor Antagonist Protein (3) · bilastine (3) · Complement C1 Inhibitor Protein (2) · Omalizumab (2) · Saline Solution (2) · avoralstat (2) · icatibant (2) · lanadelumab (2) · Abatacept (1) · Cetirizine (1) · Cyclosporine (1) · Digoxin (1) · GSK2646264 (1) · Injections (1)
Sponsors BioCryst Pharmaceuticals (6) · Shire (5) · KalVista Pharmaceuticals, Ltd. (3) · AO GENERIUM (2) · Allakos Inc. (2) · Astria Therapeutics, Inc. (2) · CSL Behring (2) · Celldex Therapeutics (2) · Faes Farma, S.A. (2) · Hangzhou Highlightll Pharmaceutical Co., Ltd (2) · Jasper Therapeutics, Inc. (2) · Johns Hopkins University (2) · Longbio Pharma (2) · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (2) · United BioPharma (2)
Countries United States (26) · Germany (13) · United Kingdom (12) · China (9) · Australia (6) · Canada (6) · South Korea (3) · Bulgaria (2) · France (2) · Netherlands (2) · Russia (2) · Spain (2) · Bangladesh (1) · Czechia (1) · India (1)
Top investigators Joanne Collier, MBChB, FFPM, Dip Stats (OU) (2) · Clifton O. Bingham, III, MD (1) · Clifton O. Bingham, M.D. (1) · David Hoover, MD (1) · Firas Almazedi, MBChB, Msc, CPI (1) · Gunilla Hedlin, Prof. Dr. (1) · Hae-Sim Park (1) · Hyeong Ki Lee, Professor (1) · Jason Lickliter, MBBS, PhD (1) · Joanne Collier (1)
Results publications PMID 12384926 , PMID 15201414 , PMID 15334472 , PMID 1538192 , PMID 15577929 , PMID 16375711 , PMID 16899778 , PMID 18645136 , PMID 21642470 , PMID 22294344 , PMID 22393898 , PMID 24105252 , PMID 24980392 , PMID 25223501 , PMID 25426834 , PMID 26016741 , PMID 27143789 , PMID 28118536 , PMID 28225674 , PMID 34020509 , PMID 35086692 , PMID 38294975 , PMID 39445704 , PMID 40158724 , PMID 41794053 , PMID 8237108
NIH funding 2019 (2) , 2023 (2) , 2009 (1) , 2014 (1) , 2025 (1) , R01HL079184 (1) , ZIAAR041138-08 (1)