Clinical trials: Cold Contact Urticaria
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 Syndrome
The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada
This study will assess the safety, tolerability and efficacy of canakinumab treatment in Canadian patient diagnosed with cryopyrin-associated periodic syndrome over a period of 18 months.
- Trial name
- NCT01105507
- Testing
- canakinumab (company code: ACZ885D)
- Where
- 2 sites in Canada
- Volunteers
- 4 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
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
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
Cryopyrin Associated Periodic Syndrome
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Subjects With Cryopyrin Associated Periodic Syndromes (CAPS)
ZYIL1 is expected to show benefit in patients with CAPS. The present study aims to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZYIL1 when administered to subjects with CAPS.
- Trial name
- NCT05186051
- Testing
- ZYIL1 capsule
- Where
- Australia
- Volunteers
- 3 people
- Sponsor
- Zydus Lifesciences Limited
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
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 Inducible Urticaria
Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
This was a placebo controlled, phase 3 study designed to evaluate the efficacy and safety of ligelizumab in participants with chronic inducible urticaria who are inadequately controlled with H1-antihistamines
- Trial name
- PEARL-PROVOKE (NCT05024058)
- Testing
- Ligelizumab
- Where
- 24 sites in United States, Australia and 7 more
- Volunteers
- 39 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
Cryopyrin-associated Periodic Syndromes (CAPS), Familial Cold Autoinflam Syn (FCAS)
Clinical Outcomes and Safety: A Registry Study of Ilaris (Canakinumab) Patients
The purpose of this observational study is to collect additional information regarding long-term safety and effectiveness of Ilaris in the treatment of CAPS patients in clinical practice.
- Conditions
- Cryopyrin-associated Periodic Syndromes (CAPS), Familial Cold Autoinflam Syn (FCAS), Muckle-wells Syn (MWS), Neonatal Onset Multisystem Inflam Disease (NOMID)
- Trial name
- B-Confident (NCT01213641)
- Where
- 17 sites in United States, Austria and 3 more
- Volunteers
- 288 people
- 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
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
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 provide long-term safety, efficacy and tolerability of ACZ885 in CAPS patients that completed the CACZ885D2307 study
- Conditions
- Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
- Trial name
- NCT01576367
- Testing
- ACZ885
- Where
- 12 sites in Belgium, Canada and 5 more
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Subjects, Cold Urticaria
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
This is a first-in-human study aimed at determining the safety of a single dose of GTX-B001 in healthy participants and in people with chronic inducible urticaria.
- Conditions
- Healthy Subjects, Cold Urticaria, Symptomatic Dermographism, Chronic Inducible Urticaria
- Trial name
- CHILL-MC (NCT07181369)
- Testing
- GTX-B001, Normal Saline
- Where
- 5 sites in Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Granular Therapeutics Limited
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
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
NALP3 Mutation
Safety, Efficacy, Pharmacokinetics, Pharmacodynamics of ACZ885 in Patients With NALP3 Mutations and Clinical Symptoms
This study will investigate the clinical efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ACZ885, administered intravenously and subcutaneously to patients with NALP3 mutations whose clinical symptoms are…
- Trial name
- NCT00487708
- Testing
- canakinumab
- Where
- 10 sites in France, Germany and 3 more
- Volunteers
- 34 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 Inducible Urticaria, Cold Urticaria
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)
The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism…
- Conditions
- Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria, Symptomatic Dermographism
- Trial name
- NCT07266402
- Testing
- Barzolvolimab
- Where
- 72 sites in United States, Germany and 5 more
- Volunteers
- 240 people
- Sponsor
- Celldex Therapeutics