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

August 21, 2020 updated by: Novartis Pharmaceuticals

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.

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

91

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • 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
        • Novartis Investigative Site
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68305
        • Novartis Investigative Site
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • Novartis Investigative Site
    • Nordrhein-Westfalen
      • Koeln, Nordrhein-Westfalen, Germany, 50937
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Humanized monoclonal antibody against human IgE
Other Names:
  • IGE025
Placebo Comparator: 2 Placebo
placebo of omalizumab once a month via subcutaneous injection
Placebo to omalizumab
Other Names:
  • Placebo for Omalizumab

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
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.
Baseline, 4, 12, 20, 28 and 36 weeks

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)
Baseline, week 28; and the follow-up period (weeks 29-36)
Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes
Time Frame: Baseline to week 28
Baseline to week 28
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
Baseline to week 28; and follow-up period (to week 36)
Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1)
Time Frame: week -2 to -1
data points per group
week -2 to -1
Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28)
Time Frame: weeks 25 to 28
data points per group
weeks 25 to 28
Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36)
Time Frame: weeks 33 to 36
data points per group
weeks 33 to 36
Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1)
Time Frame: weeks -2 to -1
data points per group
weeks -2 to -1
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
weeks 25 to 28
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
weeks 33 to 36
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

baseline to week 28; and then follow-up to week 36
Rescue Medication During the Treatment Period
Time Frame: baseline to 28 weeks
baseline to 28 weeks
Days of Rescue Medication During the Treatment Period
Time Frame: baseline to 28 weeks
data points per group
baseline to 28 weeks
Days of Rescue Medication During the Follow-up Period
Time Frame: weeks 33 to 36
data points per group
weeks 33 to 36
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

baseline to week 28; and then follow-up to week 36
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.

baseline to week 28; and follow-up to week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2013

Primary Completion (Actual)

May 9, 2014

Study Completion (Actual)

May 9, 2014

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 5, 2012

First Posted (Estimate)

November 7, 2012

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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