- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01723072
Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy (X-ACT)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Aachen, Germany, 52074
- Novartis Investigative Site
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Augsburg, Germany, 86179
- Novartis Investigative Site
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Berlin, Germany, 13353
- Novartis Investigative Site
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Bochum, Germany, 44791
- Novartis Investigative Site
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Bonn, Germany, 53105
- Novartis Investigative Site
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Darmstadt, Germany, 64283
- Novartis Investigative Site
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Dresden, Germany, 01307
- Novartis Investigative Site
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Duesseldorf, Germany, 40225
- Novartis Investigative Site
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Erlangen, Germany, 91054
- Novartis Investigative Site
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Essen, Germany, 45147
- Novartis Investigative Site
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Freiburg, Germany, 79106
- Novartis Investigative Site
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Gera, Germany, 07548
- Novartis Investigative Site
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Halle, Germany, 06120
- Novartis Investigative Site
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Hannover, Germany, 30625
- Novartis Investigative Site
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Homburg, Germany, 66421
- Novartis Investigative Site
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Kiel, Germany, 24105
- Novartis Investigative Site
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Mainz, Germany, 55131
- Novartis Investigative Site
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Muenchen, Germany, 81377
- Novartis Investigative Site
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Muenchen, Germany, 81675
- Novartis Investigative Site
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Oldenburg, Germany, 26133
- Novartis Investigative Site
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Selters, Germany, 56242
- Novartis Investigative Site
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Wiesbaden, Germany, 65199
- Novartis Investigative Site
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Baden-Wuerttemberg
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Mannheim, Baden-Wuerttemberg, Germany, 68305
- Novartis Investigative Site
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Bavaria
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Regensburg, Bavaria, Germany, 93053
- Novartis Investigative Site
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Nordrhein-Westfalen
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Koeln, Nordrhein-Westfalen, Germany, 50937
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 Omalizumab
omalizumab once a month via subcutaneous injection.
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Humanized monoclonal antibody against human IgE
Other Names:
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Placebo Comparator: 2 Placebo
placebo of omalizumab once a month via subcutaneous injection
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Placebo to omalizumab
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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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).
Participants 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.
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Baseline, 4, 12, 20, 28 and 36 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation)
Time Frame: Baseline, week 28; and the follow-up period (weeks 29-36)
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Baseline, week 28; and the follow-up period (weeks 29-36)
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Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes
Time Frame: Baseline to week 28
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Baseline to week 28
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Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation)
Time Frame: Baseline to week 28; and follow-up period (to week 36)
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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.
min.
score = 0 ; max.
score= 100
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Baseline to week 28; and follow-up period (to week 36)
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Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1)
Time Frame: week -2 to -1
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data points per group
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week -2 to -1
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Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28)
Time Frame: weeks 25 to 28
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data points per group
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weeks 25 to 28
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Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36)
Time Frame: weeks 33 to 36
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data points per group
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weeks 33 to 36
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Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1)
Time Frame: weeks -2 to -1
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data points per group
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weeks -2 to -1
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Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28)
Time Frame: weeks 25 to 28
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data points per group
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weeks 25 to 28
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Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36)
Time Frame: weeks 33 to 36
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data points per group
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weeks 33 to 36
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Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)
Time Frame: baseline to week 28; and then follow-up to week 36
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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. Each AE-QoL question has 5 answer options (scored 1-5), with lower and higher scores indicting less and more adverse impact, respectively. The total score is calculated, which is then transformed into a linear scale that ranges from 0 to 100, with a score of 100 indicating the worst possible impairment of HRQoL |
baseline to week 28; and then follow-up to week 36
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Rescue Medication During the Treatment Period
Time Frame: baseline to 28 weeks
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baseline to 28 weeks
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Days of Rescue Medication During the Treatment Period
Time Frame: baseline to 28 weeks
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data points per group
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baseline to 28 weeks
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Days of Rescue Medication During the Follow-up Period
Time Frame: weeks 33 to 36
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data points per group
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weeks 33 to 36
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Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)
Time Frame: baseline to week 28; and then follow-up to week 36
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The UAS7 is the sum of urticaria activity scores over a seven day period. The possible range of the weekly UAS7 score is 0-42. 0 means complete response and a better outcome and 42 means no response and a worse outcome. Complete UAS7 response is defined as UAS7=0. The UAS7 is the sum of the Hive Severity Score over seven days (HSS7) and the Itch Severity Score over seven days (ISS7) . The Hive Severity Score has a scale of 0 (none) to 3 (intense/severe). Complete hives response is defined as HSS7=0. The Itch Severity Score has a scale of 0 (None) to 3 (Severe (difficult to tolerate)). Complete itch response is defined as ISS7=0 |
baseline to week 28; and then follow-up to week 36
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Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)
Time Frame: baseline to week 28; and follow-up to week 36
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change in Dermatology Quality of Life Index scores The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. |
baseline to week 28; and follow-up to week 36
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Skin Diseases, Vascular
- Hypersensitivity
- Angioedema
- Urticaria
- Chronic Urticaria
- Physiological Effects of Drugs
- Immunologic Factors
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Antibodies, Monoclonal
- Omalizumab
Other Study ID Numbers
- CIGE025EDE16
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