Clinical trials: Cold Urticaria
Healthy Volunteers
A Dose-Block Randomized, Placebo Controlled (Double-blind), Active Controlled(Open-label), Dose-escalation Study
The study design of this trial is a Dose-Block Randomized, Placebo controlled (Double-blind), Active Controlled(Open-label), Dose-escalation.
- Trial name
- NCT02175056
- Testing
- HL2351, Kineret(Anakinra)
- Where
- South Korea
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Handok Inc.
Cryopyrin-Associated Periodic Syndromes (CAPS)
HL2351 CAPS Phase II Study
This is an open label, single arm trial to evaluate the efficacy, safety, and pharmacokinetics of HL2351 in patients with cryopyrin associated periodic syndromes (CAPS).
- Trial name
- NCT02853084
- Testing
- HL2351
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Handok Inc.
Cryopyrin-associated Periodic Syndromes (CAPS)
Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)
This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-162 administered once daily for 2 weeks in subjects with cryopyrin-associated periodic syndrome (CAPS)
- Trial name
- NCT07247266
- Testing
- JTE-162
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Akros Pharma Inc.
Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS)
Ilaris NIS in Korea
This is a study to evaluate safety and effectiveness of Ilaris in adult and pediatric patients receiving the drug in a clinical setting for any of the following indications, Hereditary Periodic Fever Syndromes…
- Conditions
- Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS), Colchicine Resistance Familial Mediterranean Fever (crFMF), TNF Receptor Associated Periodic Syndrome (TRAPS)
- Trial name
- REASSURE (NCT06838143)
- Testing
- Ilaris
- Where
- South Korea
- Volunteers
- 25 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Inducible Urticaria
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE).
- Trial name
- NCT05976243
- Testing
- Remibrutinib
- Where
- 130 sites in United States, Argentina and 26 more
- Volunteers
- 362 people
- Sponsor
- Novartis Pharmaceuticals
Allergic Disease, Chronic Spontaneous Urticaria
A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases
This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following a single subcutaneous injection of YH35324 in subjects with various allergic diseases.
- Conditions
- Allergic Disease, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria, Cold Urticaria
- Trial name
- NCT05960708
- Testing
- YH35324, Omalizumab
- Where
- 9 sites in South Korea
- Volunteers
- 30 people
- Sponsor
- Yuhan Corporation
Cold Urticaria, Cold Contact Urticaria
A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria
This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria.
- Conditions
- Cold Urticaria, Cold Contact Urticaria, Symptomatic Dermographism, Symptomatic Dermatographism
- Trial name
- NCT04548869
- Testing
- CDX-0159
- Where
- Germany
- Volunteers
- 41 people
- Sponsor
- Celldex Therapeutics
Chronic Cold Urticaria
A Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria
This is a phase 1b, open label, non-randomized, sequential dose-escalation, multicenter trial in adult patients with chronic cold urticaria.
- Trial name
- NCT05510843
- Testing
- THB001
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 5 people
- Sponsor
- Third Harmonic Bio, Inc.
Systemic Juvenile Idiopathic Arthritis, Hereditary Periodic Fevers
A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies
The objective of this extension protocol is to collect safety data (serious and non-serious adverse events) and to provide continuous canakinumab to patients in France who completed study CACZ885G2301E1(NCT00891046), CACZ885G2306…
- Trial name
- NCT02334748
- Testing
- canakinumab
- Where
- 3 sites in France
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Cold Urticaria
Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)
Primary Objective: To demonstrate the efficacy of dupilumab in adult and adolescent participants with primary acquired chronic inducible cold urticaria (ColdU) who remain symptomatic despite the use of an H1-antihistamine…
- Trial name
- NCT04681729
- Testing
- Dupilumab SAR231893, Non sedating H1-antihistamine
- Where
- 33 sites in United States, Argentina and 3 more
- Volunteers
- 82 people
- Sponsor
- Sanofi
Chronic Inducible Urticaria, Chronic Spontaneous Urticaria
Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)
This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of BLU-808, a wild type KIT inhibitor, in participants…
- Trial name
- NCT06931405
- Testing
- BLU-808
- Where
- 47 sites in United States, Denmark and 4 more
- Volunteers
- 105 people
- Sponsor
- Blueprint Medicines Corporation
Cryopyrin-Associated Periodic Syndromes
Kineret CAPS Post Authorisation Study
A non-interventional, post authorization safety study to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies…
- Trial name
- NCT02326376
- Testing
- anakinra (Kineret)
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 12 people
- Sponsor
- Swedish Orphan Biovitrum
Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome
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
This trial will assess the safety, efficacy and tolerability of ACZ885 in patients aged 4 years and younger with cryopyrin associated periodic syndromes (CAPS)
- Conditions
- Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
- Trial name
- NCT01302860
- Testing
- ACZ885
- Where
- 12 sites in Belgium, Canada and 5 more
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria…
- Trial name
- NCT06865651
- Testing
- Remibrutinib
- Where
- 17 sites in United States, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
NOMID, CINCA Syndrome
Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease
This study will examine whether a medicine called canakinumab is safe and effective for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurologic, cutaneous…
- Trial name
- NCT00770601
- Testing
- Canakinumab
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome
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
To date there are no approved effective therapies for the treatment of cryopyrin-associated periodic syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), or Neonatal Onset…
- Conditions
- Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
- Trial name
- NCT00991146
- Testing
- canakinumab
- Where
- 3 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
Cryopyrin-Associated Periodic Syndrome
Study of ATI-450 in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS)
This is a Phase 2 study to investigate the safety and efficacy of ATI-450 for the Maintenance of Remission in Patients with Cryopyrin-Associated Periodic Syndrome (CAPS) Previously Managed with Anti-IL-1 Therapy.
- Trial name
- NCT04524858
- Testing
- ATI-450
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Aclaris Therapeutics, Inc.
Chronic Spontaneous Urticaria, Cholinergic Urticaria
Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria
The purpose of the study is to investigate the mechanism of action for ligelizumab (QGE031) treatment in patients with chronic urticaria. The study has two parts.
- Conditions
- Chronic Spontaneous Urticaria, Cholinergic Urticaria, Cold Urticaria
- Trial name
- MASTER (NCT04513548)
- Testing
- Ligelizumab
- Where
- Germany
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Muckle Wells Syndrome
Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome
This study is designed to provide efficacy and safety data for ACZ885 (a fully human anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection subcutaneously (s.c.) in patients with Muckle-Wells…
- Trial name
- REMITTER (NCT00465985)
- Testing
- ACZ885
- Where
- 12 sites in United States, France and 4 more
- Volunteers
- 35 people
- Sponsor
- Novartis
Healthy Volunteers, Cryopyrin Associated Periodic Syndrome
Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334
This is a first in human (FIH), single-centre, double -blind, randomised, cross-over, SAD followed by a MAD study of IZD334 conducted in healthy adult participants as well as an open-label cohort in adult patients with CAPS.
- Trial name
- NCT04086602
- Testing
- IZD334
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Inflazome UK Ltd