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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Administered by subcutaneous injection
Participants received a single subcutaneous placebo injection on Day 0 of the study.
Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10 mg QD or Desloratadine 5 mg QD
Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)
Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4
The UAS is a composite diary-recorded score, which is the sum of the numeric severity intensity ratings (0 = none to 3 = intense) for 1) the number of wheals (hives) and 2) the intensity of the pruritus (itch). The UAS7 is the sum of the daily average UAS (morning and evening values) for 7 days. The maximum UAS7 score is 42.
Time frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Change in the Weekly Pruritus Score From Baseline to Week 4
The pruritus (itch) score was recorded by participants twice daily (morning and evening) based on the severity of itch over the last 12 hours, using a scale from 0 (none) to 3 (severe). The weekly pruritus score was the sum of average daily pruritus scores over the previous 7 days. The range of the weekly score is 0-21.
Time frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Change in the Weekly Score for Number of Hives From Baseline to Week 4
The number of hives was recorded by participants twice daily (morning and evening) using a scale from 0 (no hives) to 3 (more than 12 hives). The weekly score of number of hives was the sum of the average daily scores over the previous 7 days, and ranged from 0 to 21.
Time frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Change in the Weekly Score for Sleep Interference From Baseline to Week 4
The extent to which hives or itch interfered with participants' sleep was recorded once daily in the patient diary using a scale from 0 (no interference) to 3 (substantial interference, waking often). The weekly score of sleep interference was the sum of the daily scores over the previous 7 days, and ranged from 0 to 21.
Time frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4
Diphenhydramine 25mg was provided and used on an as-needed basis (maximum 3 times/day) as rescue medication. The weekly score for the amount of rescue medication is the sum of the daily scores for the amount of rescue medication used at each day in the week, and ranged from 0 to 21.
Time frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Number of Patients With Adverse Events by Severity
The severity (i.e. intensity) of each Adverse Event (AE) was graded according to the following scale: Mild: Symptoms causing no or minimal interference with usual social and functional activities. Moderate: Symptoms causing greater than minimal interference with usual social and functional activities. Severe: Symptoms causing inability to perform usual social and functional activities. Additional AE data is provided in the AE section below. The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of an AE. A "Serious" AE is defined below.
Time frame: 16 weeks overall (data reported separately for "up to 4 weeks" and "Weeks 5 to 16")
Number of Participants With Immunogenicity
Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA).
Time frame: 16 weeks
Maximum Observed Concentration (Cmax) of Omalizumab
Cmax is the maximum (or peak) concentration of omalizumab in serum.
Time frame: 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)
Time to Maximum Concentration (Tmax) of Omalizumab
Tmax is the time to maximum concentration of omalizumab.
Time frame: 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)
Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)
AUCinf is the area under the concentration-time curve from time of dosing extrapolated to infinity. AUCinf was measured in microgram times day per milliliter (µg\*day/mL). Only participants having complete profiles and completed the study were included in the analysis.
Time frame: 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)
Terminal Half-Life (t1/2) of Omalizumab
Terminal Half-Life (t1/2) is the time required for the serum concentration of omalizumab to decrease by half in the final stage of its elimination.
Time frame: 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)
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