A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
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 chronic idiopathic urticaria (CIU) refractory to H1 antihistamines, H2 blockers, and/or leukotriene receptor antagonists (LTRA) at the time of randomization.
* The presence of itch and hives for \> 6 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine (up to 4 times the approved dosage), H2 blocker, and/or LTRA treatment during this time.
* Urticaria activity score over 7 days (UAS7) score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to randomization (Week 0).
* In-clinic UAS ≥ 4 on at least one of the screening visit days (Day -14, Day -7, or Day 1).
For women of childbearing potential, agreement to use an acceptable form of contraception and to continue its use for the duration of the study.
You may not be if
Treatment with an investigational agent within 30 days prior to screening.
Weight less than 20 kg (44 lbs).
Clearly defined underlying etiology for chronic urticarias other than CIU.
Evidence of parasitic infection.
Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or other skin disease associated with itch.
Previous treatment with omalizumab within a year prior to screening.
Routine doses of the following medications within 30 days prior to screening: Systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening.
Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to screening.
Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved.
Hypersensitivity to omalizumab or any component of the formulation.
History of anaphylactic shock.
Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients.
Evidence of current drug or alcohol abuse.
Clareo Health | A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
