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NCT01287117 · ClinicalTrials.gov registry record · Phase 3

A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment

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

Completed
Registry status
Phase 3
Development phase
319
Enrollment target
20
Study locations

NCT01287117 is a Phase 3 study of Chronic Idiopathic Urticaria that has completed, run by Genentech. The registered enrollment target is 319 participants. The trial reports 20 study locations across 10 states.

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The verdict

NCT01287117, a Phase 3 study of Chronic Idiopathic Urticaria, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 3
Development phase
319 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 efficacy and safety 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 refractory CIU and who remain symptomatic despite standard-dose H1 antihistamine treatment.

Conditions Studied

Chronic Idiopathic Urticaria

Interventions

  • DRUG Placebo
  • DRUG Omalizumab

Study Locations (20)

California

  • - Huntington Beach
  • - Long Beach
  • - Los Angeles
  • - Palmdale
  • - Sacramento
  • - San Jose
  • - Studio City

Florida

  • - Coral Gables
  • - Sarasota
  • - Tallahassee

Massachusetts

  • - Baltimore
  • - Boston
  • - Burlington

Alabama

  • - Birmingham

Colorado

  • - Centennial

District of Columbia

  • - Washington D.C.

Georgia

  • - Columbus

Illinois

  • - Springfield

Trial Details

FieldValue
Enrollment Target 319 participants
Start Date 2011-02
Est. Completion 2012-10
Phase Phase 3

Sponsor

Genentech

332 total trials

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What the Registry Record Tells You About NCT01287117

The ClinicalTrials.gov registry entry for NCT01287117 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 319 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 2 interventions - of which Placebo is the first listed.

NCT01287117 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01287117 about?

NCT01287117 is a clinical study titled "A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment". The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety 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 NCT01287117?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 319 participants. The study started on 2011-02. Estimated completion is 2012-10.

What conditions does trial NCT01287117 study?

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

What interventions are being tested in trial NCT01287117?

The interventions under investigation include: Placebo (DRUG), Omalizumab (DRUG).

Who is sponsoring clinical trial NCT01287117?

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

Where is trial NCT01287117 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. 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.