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Completed

NCT Number: NCT00866788

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

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.

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Key information

Conditions

Chronic Idiopathic Urticaria Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Omalizumab

Drug

Administered by subcutaneous injection

Other names: Xolair

Placebo

Drug

Participants received a single subcutaneous placebo injection on Day 0 of the study.

H1 antihistamines

Drug

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

Drug

Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 23, 2009
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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