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 )

November 5, 2012
November 7, 2012
February 24, 2015
January 2013
May 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01723072 on Archive Site
  • 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.
Same as current
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Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy
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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Chronic Spontaneous Urticaria
  • Angioedema
  • Biological: Omalizumab
    Humanized monoclonal antibody against human IgE
    Other Name: IGE025
  • Drug: Placebo
    Placebo to omalizumab
    Other Name: Placebo for Omalizumab
  • Experimental: 1 Omalizumab
    omalizumab once a month via subcutaneous injection.
    Intervention: Biological: Omalizumab
  • Placebo Comparator: 2 Placebo
    placebo of omalizumab once a month via subcutaneous injection
    Intervention: Drug: Placebo
Staubach P, Metz M, Chapman-Rothe N, Sieder C, Bräutigam M, Canvin J, Maurer M. Effect of omalizumab on angioedema in H1 -antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial. Allergy. 2016 Aug;71(8):1135-44. doi: 10.1111/all.12870. Epub 2016 Mar 31. Erratum in: Allergy. 2017 Sep;72 (9):1430.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2014
May 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP