Back to resultsA Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
Primary Purpose
Chronic Idiopathic Urticaria
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
omalizumab
placebo
H1 antihistamines
Diphenhydramine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Idiopathic Urticaria focused on measuring Xolair, CIU
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Omalizumab 75 mg
Omalizumab 300 mg
Omalizumab 600 mg
Placebo
Arm Description
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.).
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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).
Maximum Observed Concentration (Cmax) of Omalizumab
Cmax is the maximum (or peak) concentration of omalizumab in serum.
Time to Maximum Concentration (Tmax) of Omalizumab
Tmax is the time to maximum concentration of omalizumab.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00866788
Brief Title
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Urticaria
Keywords
Xolair, CIU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omalizumab 75 mg
Arm Type
Experimental
Arm Description
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.).
Arm Title
Omalizumab 300 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Omalizumab 600 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
omalizumab
Other Intervention Name(s)
Xolair
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Participants received a single subcutaneous placebo injection on Day 0 of the study.
Intervention Type
Drug
Intervention Name(s)
H1 antihistamines
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Intervention Description
Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)
Primary Outcome Measure Information:
Title
Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4
Description
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)
Secondary Outcome Measure Information:
Title
Change in the Weekly Pruritus Score From Baseline to Week 4
Description
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)
Title
Change in the Weekly Score for Number of Hives From Baseline to Week 4
Description
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)
Title
Change in the Weekly Score for Sleep Interference From Baseline to Week 4
Description
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)
Title
Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4
Description
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)
Title
Number of Patients With Adverse Events by Severity
Description
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")
Title
Number of Participants With Immunogenicity
Description
Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA).
Time Frame
16 weeks
Title
Maximum Observed Concentration (Cmax) of Omalizumab
Description
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)
Title
Time to Maximum Concentration (Tmax) of Omalizumab
Description
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)
Title
Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)
Description
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)
Title
Terminal Half-Life (t1/2) of Omalizumab
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Rosen, M.D., Ph.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
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