Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01723072
Phase
PHASE3
Status
Completed

Conditions

  • Angioedema
  • Chronic Spontaneous Urticaria

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — BIOLOGICAL
    Humanized monoclonal antibody against human IgE
  • Placebo — DRUG
    Placebo to omalizumab

Study Details

This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.

Key Dates

First listed
Nov 7, 2012
Start date
Jan 23, 2013
Status verified
Aug 2020
Primary completion
May 9, 2014
Completion
May 9, 2014

Study Design

Enrollment
91 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1 Omalizumab
    omalizumab once a month via subcutaneous injection.
  • Placebo Comparator: 2 Placebo
    placebo of omalizumab once a month via subcutaneous injection

Primary Outcome Measure

Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS) [ Time Frame: Baseline, 4, 12, 20, 28 and 36 weeks ]

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