Chronic Urticaria
Conditions
Keywords
Chronic Idiopathic Urticaria, CIU, Urticaria, Chronic Hives, Xolair
Brief summary
This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.
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.
Interventions
DRUGOmalizumab
Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
Sponsors
Genentech, Inc.
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omalizumab Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center. | 7 |
| Controls Control subjects without urticaria who did not receive omalizumab | 3 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Omalizumab | Controls | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
| Urticaria Activity Score for 7 days | 30 units on a scale STANDARD_DEVIATION 11 | — | 30 units on a scale STANDARD_DEVIATION 11 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 3 |
| other Total, other adverse events | 3 / 7 | 0 / 3 |
| serious Total, serious adverse events | 0 / 7 | 0 / 3 |
Outcome results
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.
Time frame: Baseline through week 13
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Omalizumab Responders | Change in the Basophil Proteome | Baseline | 4 Participants |
| Controls | Change in the Basophil Proteome | Baseline | 0 Participants |
| Omalizumab Non-responders | Change in the Basophil Proteome | Baseline | 3 Participants |
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.
Time frame: Baseline through week 13
Population: 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.