Phase 4
N=10
Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria
Chronic Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT01701583 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Change in the Basophil Proteome — 4; 0; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omalizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Apr 2016
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. |
— | — |
Summary
This study looks at changes in cell proteins in people with chronic hives treated with 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). 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.