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

NCT01287117 is a Phase 3 study of Chronic Idiopathic Urticaria that has completed, run by Genentech. The registered enrollment target is 319 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.

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
Genentech

332 total trials

What the finished NCT01287117 record still lists

NCT01287117 is an interventional study that assigns participants to a tested intervention. The registered 319 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).

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 names 20 study sites across 10 states, led by 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.

Learn More About Clinical Trials

Similar trials for Chronic Idiopathic Urticaria

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01287117's enrollment target sits among peer trials

319 1087th of 2000 higher than 914 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01287117, the US trial registry maintained by the National Library of Medicine. NCT01287117 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.