Clinical trial NCT00866788: A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Idiopathic Urticaria
Keywords: Xolair
CIU
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-23
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll approximately 76 patients at approximately 45 study centers in the United States and Germany.


Eligibility criteria: Inclusion Criteria:

* CIU diagnosis \> 3 months (by history)
* No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria)

Exclusion Criteria:

* Pregnant, breastfeeding, or women not taking contraception
* Patients \< 40kg
* Treatment with any investigational agent within 30 days of screening
* Recent history of drug or alcohol abuse
* Atopic dermatitis or other skin disease associated with pruritus
* Clinically relevant major systemic disease (making interpretation of the study results difficult)
* Previously treated with omalizumab (\< 12 months since last injection)
* Patients may not take during treatment period or have been taking within the past 3 months any of the following medications/treatments: regular (daily/every other day) hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, IVIG, or plasmapheresis
* Patients may not have been taking doxepin within the past 6 weeks regular (daily/every other day).

Primary outcomes:
measure: Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4
timeFrame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Secondary outcomes:
measure: Change in the Weekly Pruritus Score From Baseline to Week 4
timeFrame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
measure: Change in the Weekly Score for Number of Hives From Baseline to Week 4
timeFrame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
measure: Change in the Weekly Score for Sleep Interference From Baseline to Week 4
timeFrame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
measure: Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4
timeFrame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
measure: Number of Patients With Adverse Events by Severity
timeFrame: 16 weeks overall (data reported separately for "up to 4 weeks" and "Weeks 5 to 16")
measure: Number of Participants With Immunogenicity
timeFrame: 16 weeks
measure: Maximum Observed Concentration (Cmax) of Omalizumab
timeFrame: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
measure: Time to Maximum Concentration (Tmax) of Omalizumab
timeFrame: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
measure: Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)
timeFrame: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
measure: Terminal Half-Life (t1/2) of Omalizumab
timeFrame: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Karin Rosen, M.D., Ph.D.
role: STUDY_DIRECTOR
References: