Clinical trials: Urticaria
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
THB335-201 is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adults with CSU who remain symptomatic despite standard-of-care treatment.
- Trial name
- NCT07766499
- Testing
- THB335 Lower Dose, THB335 Higher Dose
- Volunteers
- 81 people
- Sponsor
- Calixis Inc.
Chronic Spontaneous Urticaria
Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001
An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study.
- Trial name
- NCT06577116
- Testing
- AK006 IV
- Where
- 14 sites in United States, Canada
- Volunteers
- 29 people
- Sponsor
- Allakos Inc.
Urticaria
A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study
This is a Phase II, multicenter, open-label extension (OLE) study to evaluate the long-term safety and efficacy of fenebrutinib in participants with Chronic Spontaneous Urticaria (CSU) who have completed the treatment period in a…
- Trial name
- NCT03693625
- Testing
- GDC-0853
- Where
- 10 sites in United States
- Volunteers
- 31 people
- Sponsor
- Genentech, Inc.
Chronic Idiopathic Urticaria
Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment
The study is designed to explore the mode of action for omalizumab therapy in patients with chronic idiopathic urticaria.
- Trial name
- NCT01599637
- Testing
- IGE025
- Where
- 4 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Rhinitis, Urticaria
Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria
Eligible patients will be prescribed Desloratadine 1 tablet of 5 mg once daily. Patients will be asked to follow-up for a final visit after 14 days (Day 15) where the safety, tolerability and clinical efficacy will be measured.
- Trial name
- Aerius (NCT00724698)
- Testing
- Desloratadine
- Volunteers
- 3,011 people
- Sponsor
- Organon and Co
Hereditary Angioedema, Hereditary Angioedema Type I
Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand…
- Conditions
- Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II, Hereditary Angioedema Types I and II
- Trial name
- RAPIDe-3 (NCT06343779)
- Where
- 76 sites in United States, Argentina and 27 more
- Volunteers
- 134 people
- Sponsor
- Pharvaris Netherlands B.V.
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.
Urticaria
A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03736)
This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily during a 28-day treatment period.
- Trial name
- NCT00751166
- Testing
- Desloratadine, Cetirizine
- Volunteers
- 149 people
- Sponsor
- Organon and Co
Chronic Spontaneous Urticaria
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to < 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by…
- Trial name
- NCT05677451
- Testing
- LOU064 (blinded)
- Where
- 49 sites in United States, Argentina and 15 more
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Hereditary Angioedema
An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates
This is an open-label, single sequence study to evaluate the effect of BCX7353 on hepatic and intestinal cytochrome P450 enzymes using probe substrate drugs in healthy subjects.
- Trial name
- NCT02819102
- Testing
- BCX7353 and probes
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Hereditary Angioedema Type I, Angioneurotic Edema
Kinetics, Efficacy and Safety of C1-Esteraseremmer-N
A multicentre study to investigate pharmacokinetics, clinical efficacy and safety of nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the treatment of hereditary angioedema (HAE) will be…
- Trial name
- NCT00119431
- Testing
- C1 inhibitor concentrate
- Where
- 2 sites in Netherlands
- Volunteers
- 12 people
- Sponsor
- Prothya Biosolutions
Schnitzler Syndrome, Urticarial Vasculitis With Monoclonal Immunoglobulin M Component, Schnitzler (Disorder)
Study of the Efficacy and Safety of RPH-104 in Adult Subjects With Schnitzler Syndrome
The primary goal of the study is to assess the efficacy and safety of RPH-104 in subjects with Schnitzler Syndrome using Schnitzler Disease Activity Score (SDAS), which includes the Physician's Global Assessment (PGA) and the…
- Trial name
- NCT04213274
- Testing
- 80 mg RPH-104
- Where
- 4 sites in United States
- Sponsor
- R-Pharm Overseas, Inc.
Urticaria
A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of GDC-0853 compared with placebo in participants with Refractory Chronic Spontaneous Urticaria (CSU) already treated with anti-histamines.
- Trial name
- NCT03137069
- Testing
- GDC-0853
- Where
- 27 sites in United States, Canada and 1 more
- Volunteers
- 134 people
- Sponsor
- Genentech, Inc.
Angioedema
A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)
The main aim of this study is to check if repeated subcutaneous (SC) injections of lanadelumab can prevent angioedema attacks in teenagers and adults with non-histaminergic angioedema with normal C1-INH.
- Trial name
- NCT04206605
- Testing
- Lanadelumab
- Where
- 45 sites in United States, Canada and 8 more
- Volunteers
- 77 people
- Sponsor
- Takeda
Hereditary Angioedema (HAE)
A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home
The main aim of this study is to describe the treatment patterns, characteristics and outcomes of people with HAE who are currently receiving icatibant in the homecare setting in the United Kingdom (UK).
- Trial name
- NCT05489640
- Testing
- No Intervention
- Where
- United Kingdom
- Volunteers
- 85 people
- Sponsor
- Takeda
Healthy Volunteers
Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair®
An open-label, randomized, in parallel groups comparative study of pharmacokinetics, pharmacodynamics, immunogenicity and safety of GNR-044 (JSC "GENERIUM", Russian Federation) and Xolair® ("Novartis Pharma AG", Switzerland)…
- Trial name
- NAP (NCT04601389)
- Testing
- Omalizumab (JSC "GENERIUM", the Russian Federation), Xolair® (Novartis Pharma AG, Switzerland)
- Where
- 2 sites in Russia
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
Chronic Spontaneous Urticaria
Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.
- Trial name
- NCT04404023
- Testing
- UB-221
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- UBP Greater China (Shanghai) Co., Ltd
Hereditary Angioedema (HAE)
A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of multiple subcutaneous administrations of DX-2930 across a range of doses in HAE participants.
- Trial name
- NCT02093923
- Testing
- DX-2930
- Where
- 14 sites in United States, Italy and 1 more
- Volunteers
- 38 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
- Trial name
- NCT02586805
- Testing
- DX-2930 - 300mg/2wk, DX-2930 - 300mg/4wk, DX-2930 - 150mg/4wk
- Where
- 41 sites in United States, Canada and 5 more
- Volunteers
- 125 people
- Sponsor
- Shire
Chronic Spontaneous Urticaria
Global Managed Access Program Cohort for Ligelizumab in CSU
Global Cohort Managed Access Program (MAP) to provide access to ligelizumab (QGE031) for chronic spontaneous urticaria (CSU)
- Trial name
- NCT04903613
- Testing
- Ligelizumab
- Sponsor
- Novartis Pharmaceuticals