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)
Overview
- Phase
- Phase 2
- Intervention
- omalizumab
- Conditions
- Chronic Idiopathic Urticaria
- Sponsor
- Genentech, Inc.
- Enrollment
- 90
- Primary Endpoint
- Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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).
Arms & Interventions
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.).
Intervention: omalizumab
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.).
Intervention: H1 antihistamines
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.).
Intervention: Diphenhydramine
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.
Intervention: omalizumab
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.
Intervention: H1 antihistamines
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.
Intervention: Diphenhydramine
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.
Intervention: omalizumab
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.
Intervention: H1 antihistamines
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.
Intervention: Diphenhydramine
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.
Intervention: omalizumab
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.
Intervention: placebo
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.
Intervention: H1 antihistamines
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.
Intervention: Diphenhydramine
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of Participants With Immunogenicity(16 weeks)
- Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)(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))
- Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4(Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27))
- Terminal Half-Life (t1/2) 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))
- Change in the Weekly Pruritus Score From Baseline to Week 4(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(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(Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27))
- Number of Patients With Adverse Events by Severity(16 weeks overall (data reported separately for "up to 4 weeks" and "Weeks 5 to 16"))
- Time to Maximum Concentration (Tmax) 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))
- Maximum Observed Concentration (Cmax) 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))