# 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

> **NCT01287117** · PHASE3 · COMPLETED · sponsor: **Genentech, Inc.** · enrollment: 319 (actual)

## Conditions studied

- Chronic Idiopathic Urticaria

## Interventions

- **DRUG:** Omalizumab
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01287117
- **Lead sponsor:** Genentech, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-02
- **Primary completion:** 2012-10
- **Final completion:** 2012-10
- **Target enrollment:** 319 (ACTUAL)
- **Last updated:** 2013-11-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01287117

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01287117, "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". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01287117. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
