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Chronic Spontaneous Urticaria clinical trials

View clinical trials related to Chronic Spontaneous Urticaria.

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NCT ID: NCT03437278 Completed - Clinical trials for Chronic Spontaneous Urticaria

Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU)

Start date: August 1, 2018
Phase: Phase 2
Study type: Interventional

This clinical study was designed to evaluate the pharmacokinetics, safety and efficacy of ligelizumab in children from 12 to < 18 years of age, with chronic spontaneous urticaria (CSU). The participants were treated with ligelizumab as an add-on therapy to approved doses of H1 antihistamines (H1AH) following the guideline on treatment of CSU.

NCT ID: NCT03328897 Completed - Clinical trials for Chronic Spontaneous Urticaria

Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria

Start date: April 26, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.

NCT ID: NCT02649218 Completed - Clinical trials for Chronic Spontaneous Urticaria

A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

Start date: May 24, 2016
Phase: Phase 2
Study type: Interventional

A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201

NCT ID: NCT02550106 Completed - Clinical trials for CHRONIC SPONTANEOUS URTICARIA

Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment

SUNRISE
Start date: April 22, 2015
Phase: Phase 4
Study type: Interventional

Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.

NCT ID: NCT02477332 Completed - Clinical trials for Chronic Spontaneous Urticaria

Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

Start date: July 15, 2015
Phase: Phase 2
Study type: Interventional

This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.

NCT ID: NCT02372604 Completed - Clinical trials for Chronic Spontaneous Urticaria

Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria

LEVURE PLUS
Start date: July 2015
Phase: Phase 3
Study type: Interventional

Chronic Spontaneous Urticaria (CSU), defined by the persistence of daily or almost daily urticaria over 6 weeks, affects 0.5% to 1% of the general population. In more than half of the cases, it lasts more than 2 years. It can dramatically alter the quality of life, in particular sleep, and generates numerous consultations and hospitalizations, with an average annual cost per patient close to 2000 euros in Europe. The treatment is based on the validated 2nd generation anti-H1 antihistamines dosage of one tablet per day whose effectiveness is satisfactory, however about half the time. In cases of severe CSU refractory to treatment with anti-H1 licensed dosage, few therapeutic alternatives exist, still off-label: the monketulast, an anti-leukotriene, ciclosporine or methotrexate, as immunosuppressants. Various studies have shown the important benefit of an expensive anti-IgE biological: the omaluzimab. Several open studies have also suggested superior efficacy and good tolerability of anti-H1 in higher dosage (double, triple or quadruple) including levocetirizine. The off-label use of these high dosages of anti-H1 is growing very rapidly in France, tending to replace the use of anti-H1 first generation or substitution to another 2nd generation anti-H1 recommended by the French Society of Dermatology. This study, under the aegis of the Urticaria Group of the French Society of Dermatology, intends to compare the efficacy of levocetirizine 4 tablets/day versus 1 tablet/day in the treatment of CSU resistant to anti-H1 licensed dosage.

NCT ID: NCT02161562 Completed - Clinical trials for Chronic Spontaneous Urticaria

OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients

OPTIMA
Start date: August 1, 2014
Phase: Phase 3
Study type: Interventional

This trial assessed the efficacy of optimized re-treatment therapy with omalizumab (150mg or 300mg) after relapse, in participants with Chronic Spontaneous Urticaria who were clinically well-controlled following their first course of treatment with omalizumab (150mg or 300mg). The study also assessed the benefit of uptitrating to 300mg dose in participants who were not well-controlled following their initial course of treatment with omalizumab 150mg, as well as the benefit of treatment extension of those patients who were not well-controlled following their initial course of treatment with omalizumab 300mg.

NCT ID: NCT01803763 Completed - Clinical trials for Chronic Spontaneous Urticaria

Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients

Start date: September 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to investigate the pathophysiological mechanism of omalizumab in patients with documented chronic urticaria who have complaints under standard antihistamine treatment. With this study the investigators will assess the correlation between Fc-IgE receptor downregulation as well as functionality and clinical response to omalizumab treatment in patients with chronic urticaria. This may be an approach for other diseases as well, where Fc-IgE receptor crosslinking are essential. The treatment time is set for a total of 4 monthly applications of omalizumab. According to the dosage recommendations of recent studies, fixed doses of 300 mg omalizumab are administered subcutaneously.

NCT ID: NCT01723072 Completed - Clinical trials for Chronic Spontaneous Urticaria

Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy

X-ACT
Start date: January 23, 2013
Phase: Phase 3
Study type: Interventional

This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.