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

NCT00866788 | Completed Phase 2 Results

• 1 other identifier: Q4577g
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Idiopathic Urticaria

Keywords

Xolair; CIU

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (10)

• 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)

• 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)

• Number of Patients With Adverse Events by Severity

  16 weeks overall (data reported separately for "up to 4 weeks" and "Weeks 5 to 16")

Study Arms (4)

Omalizumab 75 mg

EXPERIMENTAL

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; Drug: H1 antihistamines; Drug: Diphenhydramine

Omalizumab 300 mg

EXPERIMENTAL

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; Drug: H1 antihistamines; Drug: Diphenhydramine

Omalizumab 600 mg

EXPERIMENTAL

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; Drug: H1 antihistamines; Drug: Diphenhydramine

Placebo

PLACEBO COMPARATOR

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; Drug: placebo; Drug: H1 antihistamines; Drug: Diphenhydramine

Interventions

omalizumab DRUG

Administered by subcutaneous injection

Also known as: Xolair

Omalizumab 300 mg; Omalizumab 600 mg; Omalizumab 75 mg; Placebo

placebo DRUG

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

Placebo

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

Omalizumab 300 mg; Omalizumab 600 mg; Omalizumab 75 mg; Placebo

Diphenhydramine DRUG

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

Omalizumab 300 mg; Omalizumab 600 mg; Omalizumab 75 mg; Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• CIU diagnosis \> 3 months (by history)
• No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab; Diphenhydramine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Karin Rosen, M.D., Ph.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: July 11, 2017
• Results First Posted: September 9, 2011

Record last verified: 2017-06