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A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01292473
First received: February 7, 2011
Last updated: October 9, 2013
Last verified: October 2013
Results First Received: June 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Idiopathic Urticaria
Interventions: Drug: Placebo
Drug: Omalizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo subcutaneously (sc) every 4 weeks.
Omalizumab 75 mg Omalizumab 75 mg sc every 4 weeks.
Omalizumab 150 mg Omalizumab 150 mg sc every 4 weeks.
Omalizumab 300 mg Omalizumab 300 mg sc every 4 weeks.

Participant Flow:   Overall Study
    Placebo     Omalizumab 75 mg     Omalizumab 150 mg     Omalizumab 300 mg  
STARTED     79     82     83     79  
COMPLETED     74     75     74     67  
NOT COMPLETED     5     7     9     12  
Adverse Event                 1                 0                 1                 1  
Lost to Follow-up                 1                 1                 2                 2  
Withdrawal by Subject                 3                 4                 3                 3  
Physician Decision                 0                 1                 0                 0  
Disease Progression                 0                 1                 3                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.

Reporting Groups
  Description
Placebo Placebo administered subcutaneously (sc) every 4 weeks.
Omalizumab 75 mg Omalizumab 75 mg sc every 4 weeks.
Omalizumab 150 mg Omalizumab 150 mg sc every 4 weeks.
Omalizumab 300 mg Omalizumab 300 mg sc every 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Omalizumab 75 mg     Omalizumab 150 mg     Omalizumab 300 mg     Total  
Number of Participants  
[units: participants]
  79     82     82     79     322  
Age  
[units: Years]
Mean ± Standard Deviation
  43.1  ± 12.5     39.7  ± 15.0     43.0  ± 13.2     44.3  ± 13.7     42.5  ± 13.7  
Gender  
[units: Participants]
         
Female     55     61     65     63     244  
Male     24     21     17     16     78  



  Outcome Measures
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1.  Primary:   Change From Baseline in the Weekly Itch Severity Score at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Change From Baseline in the Weekly Urticaria Activity Score (UAS7) at Week 12   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Change From Baseline in the Weekly Number of Hives Score at Week 12   [ Time Frame: Baseline, Week 12 ]

4.  Secondary:   Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12   [ Time Frame: by Week 12 ]

5.  Secondary:   Percentage of Participants With a UAS7 Less Than or Equal to 6 at Week 12   [ Time Frame: Week 12 ]

6.  Secondary:   Percentage of Weekly Itch Severity Score MID Responders at Week 12   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:   Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12   [ Time Frame: Baseline, Week 12 ]

8.  Secondary:   Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) at Week 12   [ Time Frame: Baseline, Week 12 ]

9.  Secondary:   Percentage of Angioedema-free Days From Week 4 to Week 12   [ Time Frame: Week 4 to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Genentech, Inc
phone: 800 821-8590


No publications provided by Genentech, Inc.

Publications automatically indexed to this study:

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01292473     History of Changes
Other Study ID Numbers: Q4882g
Study First Received: February 7, 2011
Results First Received: June 17, 2013
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration