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Trial record 2 of 4 for:    Omalizumab | Angio Edema

Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy (X-ACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01723072
Recruitment Status : Completed
First Posted : November 7, 2012
Last Update Posted : February 24, 2015
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Spontaneous Urticaria Angioedema Biological: Omalizumab Drug: Placebo Phase 3

Detailed Description:

This study will be conducted using a double-blind, placebo-controlled, randomized, multicenter design to investigate the impact of omalizumab on Quality of Life (QoL) in Chronic Spontaneous Urticaria (CSU) and will assess its effectiveness in reducing and/or inhibiting the occurrence, time-course and severity of angioedema episodes.

Omalizumab is administered subcutaneously every 4 weeks as an add-on therapy to the current approved treatment of adult CSU patients. The treatment period is 28 weeks which is followed by an 8-week follow-up. The study aims to enroll approximately 70 patients.

The study is divided into a 2-week screening period, a 28-week double-blind treatment phase with omalizumab or placebo-omalizumab, and an 8-week follow-up phase.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, 28-week Treatment With a 8 Week Follow-up to Investigate the Impact of Omalizumab on Quality of Life Measures and the Incidence and Severity of Angioedema Despite H1-antihistamine Therapy.
Study Start Date : January 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
Drug Information available for: Omalizumab

Arm Intervention/treatment
Experimental: 1 Omalizumab
omalizumab once a month via subcutaneous injection.
Biological: Omalizumab
Humanized monoclonal antibody against human IgE
Other Name: IGE025

Placebo Comparator: 2 Placebo
placebo of omalizumab once a month via subcutaneous injection
Drug: Placebo
Placebo to omalizumab
Other Name: Placebo for Omalizumab

Primary Outcome Measures :
  1. Chronic urticaria quality of life questionnaire (CU-Q2oL) [ Time Frame: Baseline/week 28 ]
    The CU-Q2oL is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Patients are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1= not at all to 5= very much). An overall score is calculated and normalized to a scale of 1 to 100.

Secondary Outcome Measures :
  1. Angioedema Quality of Life Score (AE-Q2oL) [ Time Frame: Baseline/week 28 ]
    The AE-Q2oL is a questionnaire for patients suffering from angioedema. It consists of 29 questions relevant to angioedema and its specific impact on quality of life. Patients are asked to respond how much they are troubled be each problem on a 5-point Likert scale (1= does not apply to 5= very much). An overall score is calculated and a higher score indicates lower quality of life. A negative change score (week 28 score minus baseline score) indicates improvement.

  2. Weekly Urticaria Score (UAS7) [ Time Frame: Baseline/week 28 ]
    A cumulative activity score, evaluated in the screening period and throughout the study. The records each evening on a daily basis symptoms of itch and hives into a patient diary. The UAS is a composite score with numeric severity intensity ratings on a scale of 0 - 3 for the number of wheals (hives) and the itch intensity. The UAS7 is the sum of the daily UAS scores over 7 days.

  3. Use of rescue medication [ Time Frame: Baseline/week 28 ]
    The intake of sedating anti-histamines as well as the use of corticosteroids will be measured on a daily basis throughout the study and summarized descriptively. The amount and rate of required rescue medication will be summarized and compared inferentially between treatment groups.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1-antihistamine treatment
  • Presence of itch an hives for more than 6 weeks
  • UAS7 score of more than 14 (range 0-42)
  • Patient has history of insufficient response to 4x of the approved dose of H1-antihistamines
  • CSU diagnosis for more than 6 months
  • Angioedema at least 4x in the last 6 months

Exclusion Criteria:

  • Patients with non urticaria associated angioedema
  • History of hypersensitivity to omalizumab or the rescue medication or to drugs of similar chemical structure
  • Evidence of parasitic infection
  • Previous treatment with omalizumab within the last 6 months prior to screening
  • History of anaphylactic shock
  • Woman who are pregnant or breast feeding
  • Other protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01723072

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Novartis Investigative Site
Aachen, Germany, 52074
Novartis Investigative Site
Augsburg, Germany, 86156
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Bochum, Germany, 44791
Novartis Investigative Site
Bonn, Germany, 53105
Novartis Investigative Site
Darmstadt, Germany, 64283
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Düsseldorf, Germany, 40225
Novartis Investigative Site
Erlangen, Germany, 91052
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Freiburg, Germany, 79106
Novartis Investigative Site
Gera, Germany, 07548
Novartis Investigative Site
Halle/Saale, Germany, 06120
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Homburg, Germany, 66421
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
Köln, Germany, 50937
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Mannheim, Germany, 68167
Novartis Investigative Site
Muenchen, Germany, 80336
Novartis Investigative Site
München, Germany, 81675
Novartis Investigative Site
Oldenburg, Germany, 26133
Novartis Investigative Site
Regensburg, Germany, 93053
Novartis Investigative Site
Selters, Germany, 56242
Novartis Investigative Site
Wiesbaden, Germany, 64191
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01723072     History of Changes
Other Study ID Numbers: CIGE025EDE16
First Posted: November 7, 2012    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic spontanous urticaria, refractory CSU, Angioedema
Additional relevant MeSH terms:
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Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Antibodies, Monoclonal
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Immunologic Factors
Physiological Effects of Drugs