30 completed, 7 recruiting, 7 terminated, 3 unknown. 17 Phase 2, 14 Phase 3, 11 Phase 1, 4 Not applicable, 1 Phase 4.
Follow Cold Urticaria: new trials by email Literature Review of Cold Urticaria trials Research Report on Cold Urticaria
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 |
|---|---|---|---|---|---|---|
| Circadian Rhythm Deregulation in Patients With CAPS Genetic analysis of NLRP3, Circadian rhythm measurement, Saliva sampling - Cryopyrin Associated Periodic Syndrome, Familial Cold Urticaria | Not applicable | Recruiting | Hospices Civils de Lyon | 30 | 2026-02-25 | 2026-02-27 |
| 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 | Akros Pharma Inc. | 5 | 2026-02-02 | 2026-10-09 |
| 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) Barzolvolimab, Matching Placebo - Chronic Inducible Urticaria, Cold Urticaria | Phase 3 | Recruiting | Celldex Therapeutics | 240 | 2026-01-15 | 2026-10-07 |
| 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 | Granular Therapeutics Limited | 72 | 2025-10-06 | 2026-09-09 |
| 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 | National Institute of Allergy and Infectious Diseases (NIAID) | 30 | 2025-09-10 | 2026-05-19 |
| Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU) BLU-808, Placebo - Chronic Inducible Urticaria, Chronic Spontaneous Urticaria | Phase 2 | Active not recruiting | Blueprint Medicines Corporation | 105 | 2025-05-28 | 2026-07-22 |
| Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria Remibrutinib, Placebo - Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU) | Phase 2 | Recruiting | Novartis Pharmaceuticals | 44 | 2025-05-22 | 2026-09-28 |
| Ilaris NIS in Korea Ilaris - Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS) | Recruiting | Novartis Pharmaceuticals | 25 | 2025-03-29 | 2026-05-19 | |
| A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines Remibrutinib, Placebo - Chronic Inducible Urticaria | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 362 | 2023-12-07 | 2026-10-15 |
| A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases YH35324, Omalizumab, Placebo - Allergic Disease, Chronic Spontaneous Urticaria | Phase 1 | Completed | Yuhan Corporation | 30 | 2023-08-23 | 2024-11-22 |
| Non-invasive Diagnosis of Cold Urticaria Cold stimulation tests / critical temperature threshold - Urticaria Cold | Not applicable | Unknown | City Clinical Hospital No.52 of Moscow Healthcare Department | 78 | 2023-05-12 | 2023-11-13 |
| A Study to Evaluate VTX2735 in Patients With Cryopyrin-associated Periodic Syndrome VTX2735 - Cryopyrin Associated Periodic Syndrome | Phase 2 | Completed | Zomagen Biosciences Ltd. | 7 | 2023-03-18 | 2025-03-10 |
| A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Subjects With Cryopyrin Associated Periodic Syndromes (CAPS) ZYIL1 capsule - Cryopyrin Associated Periodic Syndrome | Phase 2 | Completed | Zydus Lifesciences Limited | 3 | 2022-06-01 | 2022-07-11 |
| Are Mast Cells Involved in Autoinflammatory Diseases Autoinflammatory Disease, FMF | Not yet recruiting | Assistance Publique - Hôpitaux de Paris | 590 | 2022-03-01 | 2022-03-23 | |
| Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines Ligelizumab, Placebo - Chronic Inducible Urticaria | Phase 3 | Terminated | Novartis Pharmaceuticals | 39 | 2021-11-16 | 2024-06-18 |
| Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS) DFV890 - Familial Cold Autoinflammatory Syndrome | Phase 2 | Completed | Novartis Pharmaceuticals | 4 | 2021-09-20 | 2024-10-09 |
| Adult Outcomes of Children With CAPS Cryopyrin Associated Periodic Syndrome | Completed | University Hospital, Lille | 54 | 2021-09-16 | 2023-01-18 | |
| Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS) Dupilumab SAR231893, Placebo, Non sedating H1-antihistamine - Cold Urticaria | Phase 3 | Completed | Sanofi | 82 | 2020-12-10 | 2025-09-10 |
| A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria CDX-0159 - Cold Urticaria, Cold Contact Urticaria | Phase 1 | Completed | Celldex Therapeutics | 41 | 2020-11-24 | 2023-05-17 |
| Study of ATI-450 in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS) ATI-450 - Cryopyrin-Associated Periodic Syndrome | Phase 2 | Terminated | Aclaris Therapeutics, Inc. | 1 | 2020-10-23 | 2023-09-21 |
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Cryopyrin-Associated Periodic Syndromes (35) · Chronic Inducible Urticaria (8) · Familial dermographism (7) · Urticaria (6) · Multiple Pterygium Syndrome, Autosomal Dominant (5) · Chronic Urticaria (4) · Arthritis, Juvenile (2) · Mevalonate Kinase Deficiency (2) · Amyloidosis (1) · Arthralgia (1) · Arthritis, Rheumatoid (1) · Arthropathy, Neurogenic (1) · Behcet Syndrome (1) · Bronchiolitis Obliterans Syndrome (1)
Hypersensitivity (51) · Immune System Diseases (51) · Skin Diseases, Vascular (51) · Skin and Connective Tissue Diseases (51) · Hypersensitivity, Immediate (50) · Skin Diseases (50) · Urticaria (45) · Chronic Disease (43) · Disease Attributes (43) · Pathologic Processes (43) · Pathological Conditions, Signs and Symptoms (43) · Chronic Urticaria (39) · Chronic Inducible Urticaria (35) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (35)
canakinumab (10) · Interleukin 1 Receptor Antagonist Protein (4) · rilonacept (4) · Omalizumab (2) · ligelizumab (2) · remibrutinib (2) · Blood Specimen Collection (1) · Injections (1) · Saline Solution (1) · Surveys and Questionnaires (1) · Water (1) · ZYIL1 (1) · bilastine (1) · desloratadine (1) · dupilumab (1)
Novartis Pharmaceuticals (14) · Charite University, Berlin, Germany (6) · National Institute of Allergy and Infectious Diseases (NIAID) (3) · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (3) · Celldex Therapeutics (2) · Handok Inc. (2) · Novartis (2) · Aclaris Therapeutics, Inc. (1) · Akros Pharma Inc. (1) · Assistance Publique - Hôpitaux de Paris (1) · Blueprint Medicines Corporation (1) · City Clinical Hospital No.52 of Moscow Healthcare Department (1) · Granular Therapeutics Limited (1) · Hospices Civils de Lyon (1) · Inflazome UK Ltd (1)
Germany (21) · United States (21) · France (12) · Spain (10) · United Kingdom (8) · Canada (7) · South Korea (5) · Australia (4) · India (4) · Italy (4) · Belgium (3) · China (3) · Japan (3) · Poland (3) · Switzerland (3)
Marcus Maurer, MD (3) · Karoline Krause, MD (2) · Raphaela T Goldbach-Mansky, M.D. (2) · David Gordon (1) · Dr Deven Parmar, MD (1) · Eric Hachulla, MD,PhD (1) · Felix W Leung, MD (1) · Hae-Sim Park (1) · Henrik Sonnergren, MD, PhD (1) · Hirsh D Komarow, M.D. (1) · Hongmei Song (1) · Hyeong Ki Lee, Professor (1)
PMID 31161734, PMID 16899778, PMID 18668535, PMID 18668591, PMID 19494217, PMID 21356079, PMID 21859692, PMID 22152723, PMID 22294344, PMID 22583335, PMID 23031624, PMID 23380020, PMID 24906637, PMID 25223501, PMID 27143789, PMID 28118536, PMID 28389393, PMID 29134648, PMID 29638206, PMID 29649002, PMID 31874111, PMID 32252809, PMID 34001647, PMID 35289316, PMID 36973954
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