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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01287117
First received: January 27, 2011
Last updated: November 4, 2013
Last verified: November 2013
Results First Received: August 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Idiopathic Urticaria
Interventions: Drug: Omalizumab
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomized population: All randomized participants regardless of whether they received any study drug.

Reporting Groups
  Description
Placebo Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
Omalizumab 75 mg Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
Omalizumab 150 mg Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
Omalizumab 300 mg Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.

Participant Flow:   Overall Study
    Placebo     Omalizumab 75 mg     Omalizumab 150 mg     Omalizumab 300 mg  
STARTED     80     78     80     81  
Received Treatment     80     77     80     81  
COMPLETED     65     64     64     69  
NOT COMPLETED     15     14     16     12  
Adverse Event                 2                 1                 1                 1  
Lost to Follow-up                 1                 1                 0                 0  
Physician Decision                 0                 1                 1                 1  
Patient/Legal Guardian's Decision                 2                 6                 8                 5  
Disease Progression                 10                 5                 6                 5  



  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 (mITT) population: All participants randomized in the study who received at least 1 dose of study drug. 1 participant (randomized to omalizumab 75 mg) did not receive study drug and was not included in the mITT population.

Reporting Groups
  Description
Placebo Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
Omalizumab 75 mg Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
Omalizumab 150 mg Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
Omalizumab 300 mg Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
Total Total of all reporting groups

Baseline Measures
    Placebo     Omalizumab 75 mg     Omalizumab 150 mg     Omalizumab 300 mg     Total  
Number of Participants  
[units: participants]
  80     77     80     81     318  
Age  
[units: years]
Mean ± Standard Deviation
  40.4  ± 15.6     40.7  ± 15.2     41.1  ± 14.0     42.4  ± 13.2     41.2  ± 14.5  
Gender  
[units: participants]
         
Female     52     55     64     60     231  
Male     28     22     16     21     87  



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

2.  Secondary:   Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)   [ Time Frame: Baseline to Week 12 ]

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

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

5.  Secondary:   Percentage of Participants With a UAS7 Score ≤ 6 at Week 12   [ Time Frame: Week 12 ]

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

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

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

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

10.  Secondary:   Percentage of Complete Responders (UAS7 = 0) at Week 12   [ Time Frame: 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


Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01287117     History of Changes
Other Study ID Numbers: Q4881g, GA00887
Study First Received: January 27, 2011
Results First Received: August 13, 2013
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration