A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)

Chronic Idiopathic Urticaria Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866788
• Other study ID #: Q4577g
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2009
• Last updated: September 16, 2011
• Start date: March 2009

Study information

• Verified date: September 2011
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Idiopathic Urticaria
• Urticaria

Intervention

Drug:
• omalizumab
Administered by subcutaneous injection
• placebo
Participants received a single subcutaneous placebo injection on Day 0 of the study.
• H1 antihistamines
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
Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)	No
Secondary	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.	Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)	No
Secondary	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	Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)	No
Secondary	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.	Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)	No
Secondary	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.	Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)	No
Secondary	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.	4 Weeks	No
Secondary	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).	16 weeks	No