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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab | Experimental | Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug | Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Basophil Proteome | 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. | Baseline through week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab. | 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. | Baseline through week 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Dreskin, M.D., Ph.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Denver | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29671921 | Result | Stitt JM, Dzieciatkowska M, Edwards MG, Hansen K, Hedlund G, Dreskin SC. The basophil proteome in chronic spontaneous urticaria distinguishes responders to omalizumab from non-responders. Clin Exp Allergy. 2018 Jul;48(7):898-901. doi: 10.1111/cea.13149. Epub 2018 May 20. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omalizumab | Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks |
| FG001 | Controls | Control subjects without urticaria who did not receive omalizumab |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline demographic data for participants who did or did not received Omalizumab are combined in order to protect the privacy of the three control participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Omalizumab | Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center. |
| BG001 | Controls | Control subjects without urticaria who did not receive omalizumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Basophil Proteome | 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. | 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. | Posted | Count of Participants | Participants | Baseline through week 13 |
|
Baseline to week 13
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omalizumab | Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
Unable to assess primary or secondary outcome due to insufficient data at weeks 6 and 13.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jenny Stitt | University of Colorado | 303-724-7205 | jenny.stitt@ucdenver.edu |
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Urticaria Activity Score for 7 days | The Urticaria Activity Score summed over 7 days (UAS7) is a self-reported diary based measure used to assess itch severity and hive count in chronic spontaneous urticaria (CSU). Scores range from 0 to 42, with higher scores indicating more severe disease activity. | Only the 7 subjects with urticaria completed UAS7 scores. The 3 controls did not have urticaria. | Median | Standard Deviation | units on a scale |
|
| OG001 |
| Controls |
Subjects without chronic urticaria, not treated with omalizumab |
| OG002 | Omalizumab Non-responders | Subjects with chronic urticaria, treated with omalizumab who did not respond to the drug |
|
|
| Secondary | Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab. | 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. | 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. | Posted | Baseline through week 13 |
|
|
| 7 |
| 0 |
| 7 |
| 3 |
| 7 |
| EG001 | Controls | Control subjects without urticaria who did not receive omalizumab | 0 | 3 | 0 | 3 | 0 | 3 |
| Flushing | Endocrine disorders | Systematic Assessment |
|
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| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|