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NCT01264939 · ClinicalTrials.gov registry record · Phase 3

A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists

A Phase 3 study of Chronic Idiopathic Urticaria, sponsored by Genentech.

Completed
Registry status
Phase 3
Development phase
336
Enrollment target
20
Study locations

NCT01264939 is a Phase 3 study of Chronic Idiopathic Urticaria that has completed, run by Genentech. The registered enrollment target is 336 participants. The trial reports 20 study locations across 11 states.

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The verdict

NCT01264939, a Phase 3 study of Chronic Idiopathic Urticaria, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 3
Development phase
336 participants
Enrollment target
20
Study locations

Study Summary

The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with chronic idiopathic urticaria (CIU) who remain symptomatic despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).

Conditions Studied

Chronic Idiopathic Urticaria

Interventions

  • DRUG Placebo
  • DRUG Diphenhydramine
  • DRUG Omalizumab
  • DRUG H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist

Study Locations (20)

California

  • - Mission Viejo
  • - Napa
  • - Orange
  • - Sacramento
  • - San Diego

Florida

  • - Miami
  • - North Palm Beach
  • - Tampa

Kentucky

  • - Crescent Springs
  • - Owensboro

Massachusetts

  • - Brookline
  • - Brookline

Minnesota

  • - Minneapolis
  • - Rochester

Arizona

  • - Scottsdale

Georgia

  • - Savannah

Indiana

  • - Evansville

Trial Details

FieldValue
Enrollment Target 336 participants
Start Date 2011-02
Est. Completion 2012-11
Phase Phase 3

Sponsor

Genentech

332 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01264939

The ClinicalTrials.gov registry entry for NCT01264939 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 336 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Idiopathic Urticaria appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT01264939 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Kentucky.

Frequently Asked Questions

What is clinical trial NCT01264939 about?

NCT01264939 is a clinical study titled "A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists". The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed wi...

What is the current status of trial NCT01264939?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 336 participants. The study started on 2011-02. Estimated completion is 2012-11.

What conditions does trial NCT01264939 study?

This clinical trial studies the following conditions: Chronic Idiopathic Urticaria.

What interventions are being tested in trial NCT01264939?

The interventions under investigation include: Placebo (DRUG), Diphenhydramine (DRUG), Omalizumab (DRUG), H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist (DRUG).

Who is sponsoring clinical trial NCT01264939?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01264939 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.