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Completed

NCT Number: NCT00481676

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

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

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Key information

Conditions

Chronic Urticaria Chronic Disease Disease Attributes Epilepsy, Idiopathic Generalized Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omalizumab 75-375 mg

Drug

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.

Other names: Xolair

Placebo to omalizumab

Drug

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

Drug

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.

Other names: Lorano®

Clemastine

Drug

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.

Other names: Tavegil®

Primary outcomes

  1. Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)

    Time frame: Baseline to 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.

Secondary outcomes

  1. Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study

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

    Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study.

  2. 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)

    Time frame: 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.

  3. Use of Concomitant and Rescue Medications

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

    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.

  4. Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)

    Time frame: 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.

  5. Change in the Skindex Score From Baseline to the End of the Study (Week 24)

    Time frame: 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.

  6. Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)

    Time frame: 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.

  7. Patient's Global Assessment of Their Chronic Urticaria Symptoms

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

    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.

  8. Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms

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

    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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 4, 2007
Registry last updated
Oct 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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