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Urticaria clinical trials

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NCT ID: NCT05976243 Recruiting - Clinical trials for 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

Start date: December 7, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE). The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs). The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period

NCT ID: NCT05960708 Recruiting - Clinical trials for Chronic Spontaneous Urticaria

A Single Dose, Phase 1 Study of YH35324 in Patients With Various Allergic Diseases

Start date: August 23, 2023
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT05936567 Recruiting - Clinical trials for Chronic Spontaneous Urticaria

Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria

Start date: July 31, 2023
Phase: Phase 2
Study type: Interventional

This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.

NCT ID: NCT05916937 Recruiting - Clinical trials for Chronic Spontaneous Urticaria

Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

EXOTIC
Start date: January 12, 2024
Phase: Phase 4
Study type: Interventional

This study is a multicentre, randomized, open-label, non-inferiority clinical trial. The purpose and aim of this study is to investigate if patients with well controlled (UCT score score ≥ 12) chronic spontaneous urticaria (CSU) on omalizumab 300 mg every four weeks can extend treatment intervals and maintain disease control.

NCT ID: NCT05774639 Recruiting - Clinical trials for Chronic Idiopathic Urticaria

Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria

Start date: August 15, 2023
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the efficacy, safety, tolerability, and immunogenicity of ADL-018 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1 antihistamine treatment

NCT ID: NCT05677451 Recruiting - Clinical trials for 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

Start date: July 11, 2023
Phase: Phase 3
Study type: Interventional

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 H1-antihistamines 2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment 3. to collect safety data in this population for up to three years after the last dose of study treatment

NCT ID: NCT05526521 Recruiting - Clinical trials for Chronic Spontaneous Urticaria

A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)

Start date: August 25, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study is to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details include: Screening: 2 to 4 weeks; The treatment duration will be 24 weeks; Follow-up period: 12 weeks; The study duration will be 38 to 40 weeks (including screening and follow-up); The number of study visits will be 6.

NCT ID: NCT05513001 Recruiting - Clinical trials for Chronic Spontaneous Urticaria

An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

Start date: December 9, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 studies. This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.

NCT ID: NCT05497596 Recruiting - Urticaria Clinical Trials

The Association Between Human Microbiome and Vitamin D in Chronic Urticaria

Start date: August 2, 2022
Phase: N/A
Study type: Interventional

A double-blind study to evaluate the role of human microbiome and vitamin D in the development of urticaria.

NCT ID: NCT05335499 Recruiting - Clinical trials for Chronic Spontaneous Urticaria

A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria

Start date: June 28, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines