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A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00866788
First received: March 20, 2009
Last updated: May 9, 2016
Last verified: May 2016
Results First Received: July 1, 2011  
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: omalizumab
Drug: placebo
Drug: H1 antihistamines
Drug: Diphenhydramine

  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
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Reporting Groups
  Description
Placebo Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
Omalizumab 75 mg Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
Omalizumab 300 mg Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
Omalizumab 600 mg Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

Participant Flow:   Overall Study
    Placebo     Omalizumab 75 mg     Omalizumab 300 mg     Omalizumab 600 mg  
STARTED     21     23     25     21  
COMPLETED     15     17     23     16  
NOT COMPLETED     6     6     2     5  
Adverse Event                 0                 2                 0                 1  
Lost to Follow-up                 1                 1                 0                 2  
Withdrawal by Subject                 2                 1                 0                 1  
Pregnancy                 0                 1                 0                 0  
Disease progression                 3                 1                 1                 0  
Physician Decision                 0                 0                 1                 1  



  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.
Intent-to-Treat population

Reporting Groups
  Description
Placebo Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
Omalizumab 75 mg Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
Omalizumab 300 mg Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
Omalizumab 600 mg Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
Total Total of all reporting groups

Baseline Measures
    Placebo     Omalizumab 75 mg     Omalizumab 300 mg     Omalizumab 600 mg     Total  
Number of Participants  
[units: participants]
  21     23     25     21     90  
Age, Customized  
[units: participants]
         
12-<18 years     2     2     1     0     5  
18-<40 years     7     10     12     11     40  
>=40 years     12     11     12     10     45  
Gender  
[units: participants]
         
Female     17     15     17     12     61  
Male     4     8     8     9     29  



  Outcome Measures
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1.  Primary:   Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4   [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ]

2.  Secondary:   Change in the Weekly Pruritus Score From Baseline to Week 4   [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ]

3.  Secondary:   Change in the Weekly Score for Number of Hives From Baseline to Week 4   [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ]

4.  Secondary:   Change in the Weekly Score for Sleep Interference From Baseline to Week 4   [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ]

5.  Secondary:   Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4   [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ]

6.  Secondary:   Number of Patients With Adverse Events by Severity   [ Time Frame: 16 weeks overall (data reported separately for "up to 4 weeks" and "Weeks 5 to 16") ]

7.  Secondary:   Number of Participants With Immunogenicity   [ Time Frame: 16 weeks ]

8.  Secondary:   Maximum Observed Concentration (Cmax) of Omalizumab   [ Time Frame: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16) ]

9.  Secondary:   Time to Maximum Concentration (Tmax) of Omalizumab   [ Time Frame: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16) ]

10.  Secondary:   Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)   [ Time Frame: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16) ]

11.  Secondary:   Terminal Half-Life (t1/2) of Omalizumab   [ Time Frame: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16) ]


  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: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00866788     History of Changes
Other Study ID Numbers: Q4577g
Study First Received: March 20, 2009
Results First Received: July 1, 2011
Last Updated: May 9, 2016
Health Authority: United States: Food and Drug Administration