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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.
 
ClinicalTrials.gov Identifier: NCT01723072
Recruitment Status : Completed
First Posted : November 7, 2012
Results First Posted : September 9, 2020
Last Update Posted : September 9, 2020
Sponsor:
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.
Actual Study Start Date : January 23, 2013
Actual Primary Completion Date : May 9, 2014
Actual Study Completion Date : May 9, 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. 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 ]
    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.


Secondary Outcome Measures :
  1. 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) ]
  2. Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes [ Time Frame: Baseline to week 28 ]
  3. 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) ]
    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

  4. Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1) [ Time Frame: week -2 to -1 ]
    data points per group

  5. Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28) [ Time Frame: weeks 25 to 28 ]
    data points per group

  6. Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36) [ Time Frame: weeks 33 to 36 ]
    data points per group

  7. Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1) [ Time Frame: weeks -2 to -1 ]
    data points per group

  8. Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28) [ Time Frame: weeks 25 to 28 ]
    data points per group

  9. Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36) [ Time Frame: weeks 33 to 36 ]
    data points per group

  10. 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 ]

    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


  11. Rescue Medication During the Treatment Period [ Time Frame: baseline to 28 weeks ]
  12. Days of Rescue Medication During the Treatment Period [ Time Frame: baseline to 28 weeks ]
    data points per group

  13. Days of Rescue Medication During the Follow-up Period [ Time Frame: weeks 33 to 36 ]
    data points per group

  14. 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 ]

    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


  15. 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 ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01723072


Locations
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Germany
Novartis Investigative Site
Mannheim, Baden-Wuerttemberg, Germany, 68305
Novartis Investigative Site
Regensburg, Bavaria, Germany, 93053
Novartis Investigative Site
Koeln, Nordrhein-Westfalen, Germany, 50937
Novartis Investigative Site
Aachen, Germany, 52074
Novartis Investigative Site
Augsburg, Germany, 86179
Novartis Investigative Site
Berlin, Germany, 13353
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
Duesseldorf, Germany, 40225
Novartis Investigative Site
Erlangen, Germany, 91054
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Freiburg, Germany, 79106
Novartis Investigative Site
Gera, Germany, 07548
Novartis Investigative Site
Halle, Germany, 06120
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Homburg, Germany, 66421
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Muenchen, Germany, 81377
Novartis Investigative Site
Muenchen, Germany, 81675
Novartis Investigative Site
Oldenburg, Germany, 26133
Novartis Investigative Site
Selters, Germany, 56242
Novartis Investigative Site
Wiesbaden, Germany, 65199
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01723072    
Other Study ID Numbers: CIGE025EDE16
First Posted: November 7, 2012    Key Record Dates
Results First Posted: September 9, 2020
Last Update Posted: September 9, 2020
Last Verified: August 2020
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic spontanous urticaria, refractory CSU, Angioedema
Additional relevant MeSH terms:
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Angioedema
Urticaria
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