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

Novartis49 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Urticaria

Interventions

Omalizumab 75-375 mgDRUG

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 omalizumabDRUG

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.

LoratadineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (11)

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Bonn, Germany

Novartis Investigative Site

Cologne, Germany

Novartis Investigative Site

Dresden, Germany

Outcomes

Primary Outcomes

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.

Time frame: Baseline to end of the study (Week 24)

Secondary Outcomes

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.

Time frame: At the end of the study (Week 24)

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.

Time frame: Baseline to the end of the study (Week 24)

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.

Time frame: At Weeks 4, 8, 12, 16, 20, and 24

Data from ClinicalTrials.gov

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ClemastineDRUG

Novartis Investigative Site

Giessen, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Hanover, Germany

Novartis Investigative Site

Leipzig, Germany

Novartis Investigative Site

Lübeck, Germany

Novartis Investigative Site

Mainz, Germany

...and 1 more locations

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.

Time frame: Baseline to the end of the study (Week 24)

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.

Time frame: Baseline to the end of the study (Week 24)

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.

Time frame: Baseline to the end of the study (Week 24)

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.

Time frame: At Baseline and at the end of the study (Week 24)

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.

Time frame: At Baseline and at the end of the study (Week 24)