CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 418 enrolled
Drug / intervention
Omalizumab +1 moredrug
Likely dose
Omalizumab 150 mg or 300 mg by injectionAI-extracted
Key inclusion· 3
  • ✓Symptomatic CSU for at least 6 months
  • ✓On approved dose of H1-antihistamine for CSU for at least 3 consecutive days before screening
  • ✓Documented current H1-antihistamine use on initial screening visit day
Key exclusion· 3
  • ✕Clearly defined underlying etiology for chronic urticarias other than CSU (excluding physical urticaria as main manifestation)
  • ✕Other skin diseases associated with itch: urticarial vasculitis, urticaria pigmentosa, erythema multiforme
  • ✕Mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03328897
NCT03328897Phase 3Completed
CompareCT.gov

A Phase III Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment

Novartis Pharmaceuticals·interventional·Posted Nov 1, 2017·Updated Nov 4, 2020

In Brief

A Phase 3 clinical trial evaluating Omalizumab and Placebo for Chronic Spontaneous Urticaria. Completed, enrolled 418 participants across 27 sites.

Detailed Summary

The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spontaneous Urticaria
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 1, 2017
Enrollment StartApr 26, 2017
Primary CompletionJul 23, 2019
Study CompletionSep 24, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.7 years ago

Interventions

Omalizumabdrug

injection of 150mg or 300 mg

Placebodrug

Injection of placebo