Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
12–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of CIU refractory to H1 antihistamines at baseline
Presence of itch and hives for at least 8 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine treatment (up to four times the approved dose) during this time period
UAS7 score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to baseline
Participants must have been on a non-sedating H1 antihistamine treatment (up to four times the approved dose) for CIU for at least 3 consecutive days immediately prior to screening visit with continued current use on the day of the initial screening visit
CIU diagnosis for ≥ 6 months
Willing and able to complete a daily symptom eDiary for the duration of the study
You may not be if
Treatment with an investigational agent within 30 days of the initial screening visit
Body weight less than 20 kilograms
Clearly defined underlying etiology for chronic urticarias other than CIU
Evidence of a parasitic infection
Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch
Previous treatment with omalizumab within 1 year prior to the initial screening visit
Participants may not have taken during treatment period or have been taking within 30 days before the initial screening visit any of the following medications or treatments:
regular (daily/every other day during 5 or more consecutive days) systemic corticosteroids, hydroxychloroquine, methotrexate, mycophenolate, cyclosporine, cyclophosphamide, intravenous immunoglobulin G or plasmapheresis
Regular (daily/every other day) oral doxepin use within 14 days prior to the initial screening visit
Pregnant or lactating women, or women intending to become pregnant during the study
Clareo Health | A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
