Completed

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

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What is being tested

Omalizumab

+ Placebo

Drug
Who is being recruted

Chronic Urticaria+9

+ Chronic Disease

+ Hypersensitivity

From 12 to 75 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: February 2011
See protocol details

Summary

Principal SponsorGenentech, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2011

Actual date on which the first participant was enrolled.

Type I Error Rate Control Plan Primary Outcome Measure In order to maintain an overall type I error rate of 0.05 (2-sided) across the 3 omalizumab dose levels, the testing of the primary Outcome Measure was conducted in the following hierarchical order. A p-value < 0.05 is only considered statistically significant if statistical significance was claimed at the previous stage. * Stage 1: Omalizumab 300-mg group vs. placebo * Stage 2: Omalizumab 150-mg group vs. placebo * Stage 3: Omalizumab 75-mg group vs. placebo Secondary Outcome Measures A hierarchical analysis of the following secondary Outcome Measures was performed for each dose found to be significant in the primary Outcome Measure. A p-value < 0.05 is only considered statistically significant if statistical significance was claimed at the previous stage. * Stage 1: Change from baseline to Week 12 in the urticaria activity score over 7 days (UAS7) * Stage 2: Change from Baseline to Week 12 in the weekly number of hives score * Stage 3: Time to minimally important difference (MID) response in the weekly itch severity score by Week 12 * Stage 4: Percentage of participants with a UAS7 score ≤ 6 at Week 12 * Stage 5: Percentage of weekly itch severity score MID responders at Week 12 * Stage 6: Change from Baseline to Week 12 in the weekly size of the largest hive score * Stage 7: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12 * Stage 8: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12 * Stage 9: Percentage of complete responders (UAS7 = 0) at Week 12

Official TitleA Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
NCT01287117
Principal SponsorGenentech, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

319 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic UrticariaChronic DiseaseHypersensitivityHypersensitivity, ImmediateImmune System DiseasesPathologic ProcessesSkin DiseasesPathological Conditions, Signs and SymptomsUrticariaSkin and Connective Tissue DiseasesSkin Diseases, VascularDisease Attributes

Criteria

1 inclusion criteria required to participate
Diagnosis of Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) refractory to H1 antihistamines at the time of randomization.

18 exclusion criteria prevent from participating
Treatment with an investigational agent within 30 days prior to screening.

Weight < 20 kg (44 lbs).

Clearly defined underlying etiology for chronic urticarias other than CIU.

Evidence of parasitic infection.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.

Group II

Experimental
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.

Group III

Experimental
Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.

Group IV

Placebo
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers