Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT01701583
• Collaborator: Genentech, Inc. (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 54
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.

Condition or Disease	Intervention/Treatment	Phase
Chronic Urticaria	Drug: Omalizumab	Phase 4

Detailed Description

The purpose of this study is to evaluate for changes in the proteins produced in white blood cells (basophils) in patients with chronic hives who are treated with and respond to omalizumab.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Omalizumab (Xolair) on the Basophil Proteome in Patients With Chronic Idiopathic Urticaria
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omalizumab Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.	Drug: Omalizumab; Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.; Other Names: Xolair

Outcome Measures

Primary Outcome Measures

1. Change in the Basophil Proteome [Baseline through week 13]

   In patients with chronic urticaria who respond clinically to omalizumab, the proteome of blood basophils will be measured at baseline (pre-treatment) and at weeks 6 and 13 (post-treatment). The number of participants with a change observed in basophil proteome out of the total number of participants, stratified by responders and non-responders, is reported.

Secondary Outcome Measures

1. Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab. [Baseline through week 13]

   Change in basophil proteome in responders to omalizumab compared to non-responders to omalizumab. However, there was insufficient data from weeks 6 and 13 to analyze this outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chronic urticaria (hives) for more than 6 weeks.

• No improvement with standard doses of antihistamines (loratadine 10 mg daily, desloratadine 5 mg daily, fexofenadine 180 mg daily, cetirizine 10 mg daily, or levocetirizine 5 mg daily)

Exclusion Criteria:

• Taken any oral steroids for 1 month prior to beginning the study.

• Taken any other immunomodulatory drugs (sulfasalazine, hydroxychloroquine, cyclosporine, methotrexate) for 1 month prior to beginning the study.

• Physical urticaria as a primary diagnosis.

• Known allergic precipitant of urticaria such as foods.

• Urticarial Vasculitis.

• Anemia.

• Asthma.

• Serum Immunoglobulin E (IgE) >700 IU/ml.

• Women of childbearing potential not using contraception method(s), as well as women who are pregnant and/or breastfeeding.

• Known sensitivity to omalizumab or this class of drug.

• Use of any other investigational agent in the last 1 month.

• Untreated intercurrent illness.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Hospital	Denver	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver
• Genentech, Inc.

Investigators

• Principal Investigator: Stephen Dreskin, M.D., Ph.D., University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT01701583
• Other Study ID Numbers: 12-0780
• First Posted: Oct 5, 2012
• Last Update Posted: Dec 4, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Colorado, Denver: Chronic Idiopathic Urticaria; CIU; Urticaria; Chronic Hives; Xolair
• Additional relevant MeSH terms: Urticaria; Chronic Urticaria; Omalizumab

Study Results

Participant Flow

Arm/Group Title	Omalizumab	Controls
Arm/Group Description	Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks	Control subjects without urticaria who did not receive omalizumab
Period Title: Overall Study
STARTED	7	3
COMPLETED	5	3
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Omalizumab	Controls	Total
Arm/Group Description	Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.	Control subjects without urticaria who did not receive omalizumab	Total of all reporting groups
Overall Participants	7	3	10
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	3 100%	10 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	7 100%	2 66.7%	9 90%
Male	0 0%	1 33.3%	1 10%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 14.3%	0 0%	1 10%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	6 85.7%	3 100%	9 90%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Urticaria Activity Score for 7 days (units on a scale) [Median (Standard Deviation) ]
Median (Standard Deviation) [units on a scale]	30 (11)	30 (11)

Outcome Measures

1. Primary Outcome

Title	Change in the Basophil Proteome
Description	In patients with chronic urticaria who respond clinically to omalizumab, the proteome of blood basophils will be measured at baseline (pre-treatment) and at weeks 6 and 13 (post-treatment). The number of participants with a change observed in basophil proteome out of the total number of participants, stratified by responders and non-responders, is reported.
Time Frame	Baseline through week 13

Outcome Measure Data

Analysis Population Description

There were 7 subjects with chronic urticaria treated with omalizumab and 3 control subjects without chronic urticaria, not treated with omalizumab. There was insufficient data for weeks 6 and 13 to analyze primary outcome.

Arm/Group Title	Omalizumab Responders	Controls	Omalizumab Non-responders
Arm/Group Description	Subjects with chronic urticaria, treated with omalizumab who responded to the drug	Subjects without chronic urticaria, not treated with omalizumab	Subjects with chronic urticaria, treated with omalizumab who did not respond to the drug
Measure Participants	4	3	3
Baseline	4 57.1%	0 0%	3 30%

2. Secondary Outcome

Title	Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab.
Description	Change in basophil proteome in responders to omalizumab compared to non-responders to omalizumab. However, there was insufficient data from weeks 6 and 13 to analyze this outcome.
Time Frame	Baseline through week 13

Outcome Measure Data

Analysis Population Description

There were 7 subjects with chronic urticaria treated with omalizumab and 3 control subjects without chronic urticaria, not treated with omalizumab. Because the data from subsequent time points was not able to be analyzed, the investigators were unable to analyze this outcome because no change comparison could be made.

Arm/Group Title	Omalizumab Responders	Controls
Arm/Group Description	Subjects with chronic urticaria, treated with omalizumab who responded to the drug	Subjects without chronic urticaria, not treated with omalizumab
Measure Participants	0	0

Adverse Events

Time Frame	Baseline to week 13
Arm/Group Title	Omalizumab		Controls
Arm/Group Description	Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks		Control subjects without urticaria who did not receive omalizumab
All Cause Mortality
	Omalizumab		Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/3 (0%)
Serious Adverse Events
	Omalizumab		Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Omalizumab		Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/7 (42.9%)		0/3 (0%)
Endocrine disorders
Flushing	1/7 (14.3%)	1	0/3 (0%)	0
Nervous system disorders
Headache	3/7 (42.9%)	3	0/3 (0%)	0

Limitations/Caveats

Unable to assess primary or secondary outcome due to insufficient data at weeks 6 and 13.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.