Clinical Trials Logo
  1. Home
  2. Chronic Spontaneous Urticaria
  3. NCT01723072

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

Chronic Spontaneous Urticaria Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, 28-week Treatment With a 8 Week Follow-up to Investigate the Impact of Omalizumab on Quality of Life Measures and the Incidence and Severity of Angioedema Despite H1-antihistamine Therapy.

Clinical Trial Summary

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.

Clinical Trial Description

This study will be conducted using a double-blind, placebo-controlled, randomized, multicenter design to investigate the impact of omalizumab on Quality of Life (QoL) in Chronic Spontaneous Urticaria (CSU) and will assess its effectiveness in reducing and/or inhibiting the occurrence, time-course and severity of angioedema episodes.

Omalizumab is administered subcutaneously every 4 weeks as an add-on therapy to the current approved treatment of adult CSU patients. The treatment period is 28 weeks which is followed by an 8-week follow-up. The study aims to enroll approximately 70 patients.

The study is divided into a 2-week screening period, a 28-week double-blind treatment phase with omalizumab or placebo-omalizumab, and an 8-week follow-up phase. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01723072
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date January 23, 2013
Completion date May 9, 2014
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06077773 - Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria Phase 2
Completed NCT04538794 - A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria Phase 1
Completed NCT01803763 - Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients Phase 2/Phase 3
Recruiting NCT05298215 - 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 Phase 2
Terminated NCT04612725 - A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO) Phase 2
Terminated NCT05528861 - A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria Phase 2
Completed NCT04109313 - An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU Phase 2
Completed NCT03580356 - A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. Phase 3
Completed NCT03580369 - A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines Phase 3
Completed NCT05030311 - A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines Phase 3
Recruiting NCT06162728 - Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU) Phase 1/Phase 2
Completed NCT05107115 - Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine Phase 2
Recruiting NCT06042478 - A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients. Phase 3
Terminated NCT04159701 - A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria Phase 2
Completed NCT03749135 - Dupilumab in Chronic Spontaneous Urticaria Phase 2
Not yet recruiting NCT06396026 - A Study of Efficacy and Safety of TLL-018 in CSU Participants Phase 3
Completed NCT02649218 - A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients Phase 2
Active, not recruiting NCT05368285 - A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria Phase 2
Completed NCT05373355 - Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria. Phase 1
Not yet recruiting NCT06365879 - To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria Phase 3