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

ClinicalTrials.gov Identifier:

NCT00866788

First received: March 20, 2009

Last updated: September 16, 2011

Last verified: September 2011

History of Changes

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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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) ]

Show Outcome Measure 1

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) ]

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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) ]

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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) ]

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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) ]

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6. Secondary:

Number of Patients With Adverse Events by Severity [ Time Frame: 4 Weeks ]

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7. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights."

Limitations and Caveats

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
The laboratory and vital signs were not reported because no imbalance or abnormality were found."

Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590

No publications provided

Responsible Party:	Genentech
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:	September 16, 2011
Health Authority:	United States: Food and Drug Administration

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