- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00866788
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omalizumab 75 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study.
Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.).
|
Administered by subcutaneous injection
Other Names:
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)
|
Experimental: Omalizumab 300 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study.
Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Administered by subcutaneous injection
Other Names:
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)
|
Experimental: Omalizumab 600 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study.
Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Administered by subcutaneous injection
Other Names:
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)
|
Placebo Comparator: Placebo
Participants received a single subcutaneous placebo injection on Day 0 of the study.
Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Administered by subcutaneous injection
Other Names:
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)
Participants received a single subcutaneous placebo injection on Day 0 of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4
Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
|
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.
|
Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Weekly Pruritus Score From Baseline to Week 4
Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
|
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.
|
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
Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
|
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.
|
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
Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
|
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.
|
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
Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
|
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.
|
Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
|
Number of Patients With Adverse Events by Severity
Time Frame: 16 weeks overall (data reported separately for "up to 4 weeks" and "Weeks 5 to 16")
|
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. |
16 weeks overall (data reported separately for "up to 4 weeks" and "Weeks 5 to 16")
|
Number of Participants With Immunogenicity
Time Frame: 16 weeks
|
Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA).
|
16 weeks
|
Maximum Observed Concentration (Cmax) 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)
|
Cmax is the maximum (or peak) concentration of omalizumab in serum.
|
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
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)
|
Tmax is the time to maximum concentration of omalizumab.
|
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)
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)
|
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.
|
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
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) is the time required for the serum concentration of omalizumab to decrease by half in the final stage of its elimination.
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Karin Rosen, M.D., Ph.D., Genentech, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Skin Diseases, Vascular
- Hypersensitivity
- Urticaria
- Chronic Urticaria
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Hypnotics and Sedatives
- Anesthetics, Local
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Sleep Aids, Pharmaceutical
- Histamine Agents
- Antipruritics
- Diphenhydramine
- Promethazine
- Omalizumab
- Histamine H1 Antagonists
- Histamine Antagonists
Other Study ID Numbers
- Q4577g
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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