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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00866788
First received: March 20, 2009
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Chronic Idiopathic Urticaria
Drug: omalizumab
Drug: placebo
Drug: H1 antihistamines
Drug: Diphenhydramine
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA).


Enrollment: 90
Study Start Date: March 2009
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.).
Drug: omalizumab
Administered by subcutaneous injection
Other Name: Xolair
Drug: 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
Drug: Diphenhydramine
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.
Drug: omalizumab
Administered by subcutaneous injection
Other Name: Xolair
Drug: 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
Drug: Diphenhydramine
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.
Drug: omalizumab
Administered by subcutaneous injection
Other Name: Xolair
Drug: 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
Drug: Diphenhydramine
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.
Drug: omalizumab
Administered by subcutaneous injection
Other Name: Xolair
Drug: placebo
Participants received a single subcutaneous placebo injection on Day 0 of the study.
Drug: 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
Drug: Diphenhydramine
Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866788

Sponsors and Collaborators
Genentech
Investigators
Study Director: Karin Rosen, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00866788     History of Changes
Other Study ID Numbers: Q4577g
Study First Received: March 20, 2009
Results First Received: July 1, 2011
Last Updated: September 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Xolair
CIU

Additional relevant MeSH terms:
Urticaria
Omalizumab
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Diphenhydramine
Promethazine
Histamine H1 Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on April 22, 2014