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Chronic Spontaneous Urticaria clinical trials

View clinical trials related to Chronic Spontaneous Urticaria.

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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: NCT05373355 Completed - Clinical trials for Chronic Spontaneous Urticaria

Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria.

Start date: May 10, 2022
Phase: Phase 1
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 36 subjects with moderate to severe Chronic Spontaneous Urticaria.

NCT ID: NCT05368285 Active, not recruiting - Clinical trials for Chronic Spontaneous Urticaria

A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

Start date: May 19, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Spontaneous 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

NCT ID: NCT05298215 Recruiting - Clinical trials for Chronic Spontaneous Urticaria

A Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of UB-221 IV Infusion as an add-on Therapy in Patients With Chronic Spontaneous Urticaria

Start date: October 5, 2022
Phase: Phase 2
Study type: Interventional

This is a phase II, double-blind, randomized, parallel group, placebo-controlled study to evaluate the pharmacodynamics, pharmacokinetics, efficacy, and safety of 2-dose UB-221 IV infusion as an add-on therapy in patients with chronic spontaneous urticaria. The study will be conducted at multiple study centers in Taiwan. Approximate 25 eligible subjects will be randomized into two UB-221 (5 &10 mg/kg) and one placebo (saline) cohorts in a ratio of 2:2:1. The study consists of a pre-screening period (Day -42 to -29), a screening period (Day -28 to -1), a dose 1 period (Day 0 to 83), and a dose 2 period (Day 84 to 196).

NCT ID: NCT05170724 Available - Clinical trials for Chronic Spontaneous Urticaria

Global Managed Access Program Cohort for Remibrutinib in Adult Patients With Chronic Spontaneous Urticaria

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide access to remibrutinib for adult patients with chronic spontaneous urticaria (CSU)

NCT ID: NCT05169645 Not yet recruiting - Clinical trials for Chronic Spontaneous Urticaria

STOP CSUA: phySical acTivity, mOod and sleeP in Chronic Spontaneous Urticaria and Angioedema

STOP CSUA
Start date: February 1, 2022
Phase:
Study type: Observational

Chronic spontaneous urticaria and angioedema (CSUA) is a disease of the skin characterised by hives, swellings or both that last longer than 6 weeks. People with this disease commonly describe poor sleep, reduced quality of life and psychological difficulties such as depression and anxiety. This study seeks to understand relationships between physical activity, sleep and symptoms of urticaria. We are asking individuals with urticaria to wear a fitbit tracker which monitors their physical activity and sleep. Participants also download an app onto their smartphone called Athena CX which is designed by the study team in DCU. The purpose of the app is capture real-time information from participants on mood and any skin symptoms they experience. We will use this information to learn more about possible links between symptoms of urticaria and lifestyle behaviours.

NCT ID: NCT05129423 Withdrawn - Clinical trials for Chronic Spontaneous Urticaria

A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria

Start date: July 31, 2022
Phase: Phase 2
Study type: Interventional

This pilot and dose-ranging study will evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A compared with placebo in participants with chronic spontaneous urticaria (CSU) refractory to antihistamines. This study comprises two parts. In Part 1, participants will be randomized to receive MTPS9579A or placebo. On the basis of positive results from Part 1, a dose-ranging Part 2 may be opened, where participants will be randomized to receive one of four MTPS9579A doses or placebo.

NCT ID: NCT05107115 Completed - Clinical trials for Chronic Spontaneous Urticaria

Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine

RILECSU
Start date: November 24, 2021
Phase: Phase 2
Study type: Interventional

The first phase of this study will be a parallel, 12-week treatment, Phase 2, double-blind, 4 arm study to assess the safety and effectiveness of 3 oral doses of SAR444671 (rilzabrutinib), i.e. dose A, B and C, compared with placebo for decreasing the frequency and severity of itch and urticaria in male and female participants aged 18 years inclusive or older with CSU. After completion of the double-blind phase of the study, participants will be given the option of enrolling in the 40-week open label extension (OLE) phase of the study. Participants will receive open-label rilzabrutinib at dose C (the dose may be modified based on the 12-week safety and efficacy data). Due to the fact that some participants may be receiving rilzabrutinib for the first time, all participants will be monitored at Week 14, Week 16, Week 20, and Week 24. Afterwards, participants will be monitored at Week 36 and Week 52.

NCT ID: NCT05048342 Completed - Clinical trials for Chronic Spontaneous Urticaria

A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines

BISCUIT
Start date: January 15, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of remibrutinib (LOU064) in adult Japanese chronic spontaneous urticaria (CSU) participants inadequately controlled by second generation H1-antihistamines.