Phase 4
Completed N=10
Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria
Source: ClinicalTrials.gov NCT01701583 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Change in the Basophil Proteome — 4; 0; 3 Participants
◆ Published Evidence
Emerging
4citations · ~1 / year
The basophil proteome in chronic spontaneous urticaria distinguishes responders to omalizumab from non-responders.
Summary
This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.
Linked Publications
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The basophil proteome in chronic spontaneous urticaria distinguishes responders to omalizumab from non-responders.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Basophil Proteome |
4; 0; 3 | — |
| SECONDARY Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab. |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01701583) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.