Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria

Chronic Urticaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481676
• Other study ID #: CIGE025ADE05
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2007
• Last updated: September 14, 2011
• Start date: May 2007
• Est. completion date: April 2009

Study information

• Verified date: September 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Urticaria
• Urticaria

Intervention

Drug:
• Omalizumab 75-375 mg
Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg of omalizumab upon reconstitution with 1.4 ml sterile water for injection.
• Placebo to omalizumab
Placebo to omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg placebo to omalizumab upon reconstitution with 1.4 ml sterile water for injection.
• Loratadine
All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.
• Clemastine
All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Giessen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Luebeck
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)	The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement.	Baseline to end of the study (Week 24)	No
Secondary	Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study	Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study.	At the end of the study (Week 24)	No
Secondary	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)	The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. A higher score indicates worse disease. AUC was calculated from daily UASs where no urticaria medication was taken using the trapezoidal rule. The standardized AUC UAS was calculated as the sum of trapezoids divided by the length of time.	Baseline to the end of the study (Week 24)	No
Secondary	Use of Concomitant and Rescue Medications	Data was collected from the patients' diaries about the number of clemastine and loratadine pills taken during the last 7 days of each month of the study.	At Weeks 4, 8, 12, 16, 20, and 24	No
Secondary	Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)	The DLQI is a dermatology-specific quality of life (QoL) questionnaire designed for use in patients over 16 years of age. Patients are asked to respond to each of 10 questions on a 4-point Likert scale in regard to how much their skin problem has affected their life over the last week (0=not at all, 1=a little, 2=a lot, 3=very much). The overall (total) DLQI score (range=0 to 30) is calculated by summing the scores of all 10 questions. The higher the score, the more QoL is impaired. A negative change score (Week 24 score minus Baseline score) indicates improvement.	Baseline to the end of the study (Week 24)	No
Secondary	Change in the Skindex Score From Baseline to the End of the Study (Week 24)	Skindex is a 30-item questionnaire with 3 scores (functioning, emotions,symptoms) and a composite score (average scale score) that assesses the effects of skin disease on patients' quality of life (QoL). Item responses are standardized on a scale from 0 to 100. The mean of all 61 items was calculated. A higher score indicates a lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.	Baseline to the end of the study (Week 24)	No
Secondary	Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)	The CU-Q2oL (German version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It has 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Patients are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1=not at all to 5=very much). Each domain and the overall (total) scores are normalized to a scale of 1 to 100. A higher score indicates lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.	Baseline to the end of the study (Week 24)	No
Secondary	Patient's Global Assessment of Their Chronic Urticaria Symptoms	Patients made a global assessment of their chronic urticaria symptoms on a 4-point Likert scale (none, mild moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.	At Baseline and at the end of the study (Week 24)	No
Secondary	Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms	The investigator made a global assessment of the patient's chronic urticaria symptoms on a 4-point Likert scale (none, mild, moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.	At Baseline and at the end of the study (Week 24)	No