Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study plans to learn more about why some people with Chronic Idiopathic Urticaria (CIU) respond to treatment with omalizumab (Xolair). It will test people before they receive treatment with omalizumab as part of standard of care, to see if there are differences in their blood and skin that can predict who responds to treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug | omalizumab 300mg SQ every 4 weeks as part of standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responders | The number of participants who meet the definition of "Responder" to omalizumab. "Responders" are defined as having a UAS7 of 6 or less after 16 weeks of treatment. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline expression of innate immune markers | Baseline expression of innate immune markers in peripheral blood between eventual responders and nonresponders to omalizumab. 5 significant markers will be reported. Results will be stratified between groups determined by the pre-specified arms and by the classification of participants as responders versus non-responders to omalizumab. | Baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jenny Stitt, M.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D006969 |
| Hypersensitivity, Immediate |
| 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 |