Clinical trial NCT00481676: Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria
Official title: A Randomized, 24 Weeks, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Omalizumab in Adult Patients With Chronic Urticaria Who Exhibit IgE Against Thyroperoxidase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Urticaria
Keywords: Chronic urticaria, omalizumab, thyroperoxidase, IgE
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-06-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.


Eligibility criteria: Inclusion criteria:

* Males or females from 18-70 years of age
* Body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 IU/mL and ≤ 700 IU/mL
* Specific serum IgE anti-TPO level ≥ 8.0 IU/mL, documented within 3 months prior to randomization or time of pre-screening
* Diagnosis of moderate to severe chronic urticaria
* Subject's current episode of chronic urticaria according to the European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum (EAACI/GA2LEN/EDF) guideline at the time of screening
* Current episode of chronic urticaria has not responded to the approved marketed dose of antihistamine for 2 weeks or longer
* Urticaria activity score (UAS) ≥ 0 at any of the 7 days of the first section of the screening period
* UAS7 ≥ 10 at the time of randomization

Exclusion criteria:

* Females of child-bearing potential or breast feeding
* Present or past medical conditions that could have interfered with the study results
* Randomized into any other omalizumab study or who had received omalizumab
* Received investigational drugs within 30 days of enrollment

Primary outcomes:
measure: Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)
timeFrame: Baseline to end of the study (Week 24)
Secondary outcomes:
measure: Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
timeFrame: At the end of the study (Week 24)
measure: Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24)
timeFrame: Baseline to the end of the study (Week 24)
measure: Use of Concomitant and Rescue Medications
timeFrame: At Weeks 4, 8, 12, 16, 20, and 24
measure: Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)
timeFrame: Baseline to the end of the study (Week 24)
measure: Change in the Skindex Score From Baseline to the End of the Study (Week 24)
timeFrame: Baseline to the end of the study (Week 24)
measure: Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
timeFrame: Baseline to the end of the study (Week 24)
measure: Patient's Global Assessment of Their Chronic Urticaria Symptoms
timeFrame: At Baseline and at the end of the study (Week 24)
measure: Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
timeFrame: At Baseline and at the end of the study (Week 24)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Giessen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Luebeck
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Munich
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: