Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy (X-ACT)
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ClinicalTrials.gov Identifier: NCT01723072 |
Recruitment Status
:
Completed
First Posted
: November 7, 2012
Last Update Posted
: February 24, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Spontaneous Urticaria Angioedema | Biological: Omalizumab Drug: Placebo | Phase 3 |
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.
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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 Omalizumab
omalizumab once a month via subcutaneous injection.
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Biological: Omalizumab
Humanized monoclonal antibody against human IgE
Other Name: IGE025
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Placebo Comparator: 2 Placebo
placebo of omalizumab once a month via subcutaneous injection
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Drug: Placebo
Placebo to omalizumab
Other Name: Placebo for Omalizumab
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- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT01723072
Germany | |
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 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov 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:
Urticaria Angioedema Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Vascular Diseases |
Cardiovascular Diseases Omalizumab Antibodies, Monoclonal Anti-Allergic Agents Anti-Asthmatic Agents Respiratory System Agents Immunologic Factors Physiological Effects of Drugs |