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

Study Description

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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.

Study Design

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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.
Study Start Date :	January 2013
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	May 2014

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01723072 History of Changes
Other Study ID Numbers:	CIGE025EDE16
First Posted:	November 7, 2012
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