Cold Urticaria: Clinical Trials

10 completed, 2 terminated, 1 active not recruiting, 1 recruiting. 14 Phase 3, 1 Phase 2.

By phase and status

Phase	Trials	Status
Phase 3	14	Completed 10, Terminated 2, Active not recruiting 1, Recruiting 1
Phase 2	1	Completed 1

Follow Cold Urticaria: new trials by email Literature Review of Cold Urticaria trials Research Report on Cold Urticaria

Trials (filtered) newest first · largest first

All 14 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 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	2026-11-02
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
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
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 Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies canakinumab - Systemic Juvenile Idiopathic Arthritis, Hereditary Periodic Fevers	Phase 3	Completed	Novartis Pharmaceuticals	31	2014-11-03	2020-05-19
Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease ACZ885 - Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome	Phase 3	Completed	Novartis Pharmaceuticals	17	2012-01-16	2018-09-11
Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease ACZ885 - Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome	Phase 3	Completed	Novartis Pharmaceuticals	17	2010-11-01	2017-03-29
Bilastine Updosing - Characterization of Underlying Mechanisms Bilastine - Cold Contact Urticaria	Phase 2 / Phase 3	Completed	Charite University, Berlin, Germany	20	2010-09-01	2012-05-31
The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada canakinumab (company code: ACZ885D) - Cryopyrin Associated Periodic Syndrome	Phase 3	Completed	Novartis Pharmaceuticals	4	2010-08-01	2017-03-21
Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase canakinumab - Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome	Phase 3	Completed	Novartis Pharmaceuticals	19	2009-10-01	2020-09-25
Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease Canakinumab - NOMID, CINCA Syndrome	Phase 3	Terminated	Novartis Pharmaceuticals	7	2009-01-26	2021-06-10
Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease Canakinumab (ACZ885) - Cryopyrin-Associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome	Phase 3	Completed	Novartis	166	2008-05-01	2016-11-04
Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome ACZ885, Placebo - Muckle Wells Syndrome	Phase 3	Completed	Novartis	35	2007-04-01	2017-08-28
Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) rilonacept 160 mg, Placebo - Familial Cold Autoinflammatory Syndrome (FCAS), Familial Cold Urticaria	Phase 3	Completed	Regeneron Pharmaceuticals	104	2005-12-01	2011-12-06

Narrower conditions

Cryopyrin-Associated Periodic Syndromes (9)  ·  Multiple Pterygium Syndrome, Autosomal Dominant (5)  ·  Chronic Inducible Urticaria (3)  ·  Familial dermographism (2)  ·  Urticaria (2)  ·  Arthralgia (1)  ·  Arthritis, Juvenile (1)  ·  Bronchiolitis Obliterans Syndrome (1)  ·  Genetic Diseases, Inborn (1)  ·  Mevalonate Kinase Deficiency (1)  ·  Pruritus (1)  ·  Rheumatoid Arthritis, Systemic Juvenile (1)

Broader conditions

Hypersensitivity (14)  ·  Hypersensitivity, Immediate (14)  ·  Immune System Diseases (14)  ·  Skin Diseases (14)  ·  Skin Diseases, Vascular (14)  ·  Skin and Connective Tissue Diseases (14)  ·  Chronic Disease (12)  ·  Chronic Urticaria (12)  ·  Disease Attributes (12)  ·  Pathologic Processes (12)  ·  Pathological Conditions, Signs and Symptoms (12)  ·  Urticaria (12)  ·  Chronic Inducible Urticaria (9)  ·  Congenital, Hereditary, and Neonatal Diseases and Abnormalities (9)

Interventions

canakinumab (8)  ·  bilastine (1)  ·  dupilumab (1)  ·  ligelizumab (1)  ·  remibrutinib (1)  ·  rilonacept (1)

Sponsors

Novartis Pharmaceuticals (8)  ·  Novartis (2)  ·  Celldex Therapeutics (1)  ·  Charite University, Berlin, Germany (1)  ·  Regeneron Pharmaceuticals (1)  ·  Sanofi (1)

Countries

Germany (8)  ·  United States (8)  ·  Spain (7)  ·  France (6)  ·  United Kingdom (6)  ·  Canada (5)  ·  Belgium (3)  ·  India (3)  ·  Japan (3)  ·  Turkey (Türkiye) (3)  ·  Argentina (2)  ·  Australia (2)  ·  Hungary (2)  ·  Italy (2)  ·  Poland (2)

Top investigators

Marcus Maurer, MD (1)  ·  Robert Evans, PharmD. (1)

Results publications

PMID 31161734, PMID 18668535, PMID 19494217, PMID 21859692, PMID 22152723, PMID 23031624, PMID 23380020, PMID 24906637

NIH funding

2009 (1), 2014 (1), 2023 (1)