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

NCT00481676 | Completed Phase 2 Results

• 1 other identifier: CIGE025ADE05
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 11

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.

Conditions

Chronic Urticaria

Keywords

Chronic urticaria, omalizumab, thyroperoxidase, IgE

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (8)

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

  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)

  Baseline to the end of the study (Week 24)

• Use of Concomitant and Rescue Medications

  At Weeks 4, 8, 12, 16, 20, and 24

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

  Baseline to the end of the study (Week 24)

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

  Baseline to the end of the study (Week 24)

Study Arms (2)

Omalizumab 75-375 mg

EXPERIMENTAL

Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.

Drug: Omalizumab 75-375 mg; Drug: Loratadine

Placebo to omalizumab

PLACEBO COMPARATOR

Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.

Drug: Placebo to omalizumab; Drug: Loratadine; Drug: Clemastine

Interventions

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.

Also known as: Xolair

Omalizumab 75-375 mg

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.

Placebo to omalizumab

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.

Also known as: Lorano®

Omalizumab 75-375 mg; Placebo to omalizumab

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.

Also known as: Tavegil®

Placebo to omalizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (11)

Novartis Investigative Site

Berlin, Germany

Location

Novartis Investigative Site

Bonn, Germany

Location

Novartis Investigative Site

Cologne, Germany

Location

Novartis Investigative Site

Dresden, Germany

Location

Novartis Investigative Site

Giessen, Germany

Location

Novartis Investigative Site

Hamburg, Germany

Location

Novartis Investigative Site

Hanover, Germany

Location

Novartis Investigative Site

Leipzig, Germany

Location

Novartis Investigative Site

Lübeck, Germany

Location

Novartis Investigative Site

Mainz, Germany

Location

Novartis Investigative Site

Munich, Germany

Location

MeSH Terms

Conditions

Chronic Urticaria; Epilepsy, Idiopathic Generalized

Interventions

Omalizumab; Loratadine; Clemastine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins; Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Pyrrolidines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2007
• First Posted: June 4, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 21, 2011
• Results First Posted: October 21, 2011

Record last verified: 2011-09

Locations

DE (11)