Cold urticaria

Summary

Cold urticaria (MONDO:0022799) is a disease and 15 clinical trials. Top therapeutic interventions include rilonacept, bilastine, and desloratadine. A subtype of urticaria — broader associated-gene and molecular evidence is on the parent page (see Disease family below).

At a glance

• Clinical trials: 15

Clinical features

No curated clinical features (Orphanet) for this disease.

Identifiers

Disease identifiers

Field	Value
Canonical name	cold urticaria
Mondo ID	MONDO:0022799
EFO	EFO:1001881
ICD-11	915116593
SNOMED CT	74774004
UMLS	C0221207
MedGen	472942
Is cancer (heuristic)	no

Also known as: cold contact urticaria · primary idiopathic cold urticaria · urticaria idiopathic cold

Disease family

This is a subtype of urticaria. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.

Classification path: disease › human disease › disease by body system or component › integumentary system disorder › skin disorder › dermatitis › urticaria › cold urticaria

Related subtypes (13): allergic urticaria, physical urticaria, Melkersson-Rosenthal syndrome, pruritic urticarial papules and plaques of pregnancy, urticaria, aquagenic, urticaria, familial localized heat, angioedema, drug rash with eosinophilia and systemic symptoms, cutaneous mastocytosis, autoimmune urticaria, papular urticaria, idiopathic urticaria, chronic urticaria

Genetics & variants

GWAS landscape

No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.

Variant details and genetic-evidence tiers

No tiered GWAS variants or ClinVar records for this disease.

Genes & proteins

No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).

Function

No pathway enrichment — requires an associated-gene cohort.

Therapeutics

Drugs indicated for this disease

0 approved, 1 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.

Drug	Development status
Dupilumab	Phase 3 (in late-stage trials)

Earlier-phase candidates (phase 2, investigational — efficacy not yet established): Bilastine, Omalizumab, Rilonacept, Rupatadine.

Clinical trials & evidence

Clinical trials

Clinical trials: 15.

Phase distribution (across all retrieved trials)

Phase	Trials
PHASE1	6
PHASE3	3
PHASE2	3
PHASE4	1
PHASE2/PHASE3	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00600847	PHASE4	COMPLETED	A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions
NCT07266402	PHASE3	RECRUITING	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)
NCT00288704	PHASE3	COMPLETED	Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
NCT01271075	PHASE2/PHASE3	COMPLETED	Bilastine Updosing - Characterization of Underlying Mechanisms
NCT04681729	PHASE3	COMPLETED	Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)
NCT01580592	PHASE2	COMPLETED	Cold Urticaria Treatment With Xolair
NCT01605487	PHASE2	COMPLETED	Study to Assess Efficacy, Safety and Mechanism of Rupatadine in Cold Urticaria
NCT02171416	PHASE2	COMPLETED	Cold Contact Urticaria Treatment With Rilonacept
NCT07181369	PHASE1	RECRUITING	A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
NCT00214851	PHASE1	COMPLETED	The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria
NCT04513548	PHASE1	TERMINATED	Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria
NCT04548869	PHASE1	COMPLETED	A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria
NCT05510843	PHASE1	TERMINATED	A Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria
NCT05960708	PHASE1	COMPLETED	A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases
NCT06544018	Not specified	RECRUITING	Circadian Rhythm Deregulation in Patients With CAPS

Drugs tested across these trials (top 30)

Molecule	Max phase	Trials referencing
RILONACEPT	4	2
BILASTINE	4	1
DESLORATADINE	4	1
DUPILUMAB	4	1
RUPATADINE	4	1
BARZOLVOLIMAB	3	2
LIGELIZUMAB	3	1