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

Primary Purpose

Chronic Spontaneous Urticaria, Angioedema

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Omalizumab

Placebo

About this trial

This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring Chronic spontanous urticaria, refractory CSU, Angioedema

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1 Omalizumab

2 Placebo

Arm Description

omalizumab once a month via subcutaneous injection.

placebo of omalizumab once a month via subcutaneous injection

Outcomes

Primary Outcome Measures

Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS)

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

Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation)

Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes

Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation)

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

Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1)

data points per group

Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28)

data points per group

Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36)

data points per group

Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1)

data points per group

Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28)

data points per group

Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36)

data points per group

Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)

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

Rescue Medication During the Treatment Period

Days of Rescue Medication During the Treatment Period

data points per group

Days of Rescue Medication During the Follow-up Period

data points per group

Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)

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

Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)

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.

Full Information

NCT ID

NCT01723072

First Posted

November 5, 2012

Last Updated

August 21, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01723072

Brief Title

Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy

Acronym

X-ACT

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 Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

January 23, 2013 (Actual)

Primary Completion Date

May 9, 2014 (Actual)

Study Completion Date

May 9, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Spontaneous Urticaria, Angioedema

Keywords

Chronic spontanous urticaria, refractory CSU, Angioedema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 Omalizumab

Arm Type

Experimental

Arm Description

omalizumab once a month via subcutaneous injection.

Arm Title

2 Placebo

Arm Type

Placebo Comparator

Arm Description

placebo of omalizumab once a month via subcutaneous injection

Intervention Type

Biological

Intervention Name(s)

Omalizumab

Other Intervention Name(s)

IGE025

Intervention Description

Humanized monoclonal antibody against human IgE

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo for Omalizumab

Intervention Description

Placebo to omalizumab

Primary Outcome Measure Information:

Title

Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS)

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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)

Title

Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes

Time Frame

Baseline to week 28

Title

Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation)

Description

Time Frame

Baseline to week 28; and follow-up period (to week 36)

Title

Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1)

Description

data points per group

Time Frame

week -2 to -1

Title

Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28)

Description

data points per group

Time Frame

weeks 25 to 28

Title

Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36)

Description

data points per group

Time Frame

weeks 33 to 36

Title

Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1)

Description

data points per group

Time Frame

weeks -2 to -1

Title

Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28)

Description

data points per group

Time Frame

weeks 25 to 28

Title

Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36)

Description

data points per group

Time Frame

weeks 33 to 36

Title

Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)

Description

Time Frame

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

Title

Rescue Medication During the Treatment Period

Time Frame

baseline to 28 weeks

Title

Days of Rescue Medication During the Treatment Period

Description

data points per group

Time Frame

baseline to 28 weeks

Title

Days of Rescue Medication During the Follow-up Period

Description

data points per group

Time Frame

weeks 33 to 36

Title

Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)

Description

Time Frame

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

Title

Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68305

Country

Germany

Facility Name

Novartis Investigative Site

City

Regensburg

State/Province

Bavaria

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Novartis Investigative Site

City

Augsburg

ZIP/Postal Code

86179

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Novartis Investigative Site

City

Darmstadt

ZIP/Postal Code

64283

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Gera

ZIP/Postal Code

07548

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Novartis Investigative Site

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Facility Name

Novartis Investigative Site

City

Selters

ZIP/Postal Code

56242

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

ZIP/Postal Code

65199

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

27010957

Citation

Staubach P, Metz M, Chapman-Rothe N, Sieder C, Brautigam 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.

Results Reference

derived

Learn more about this trial

Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy

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

Chronic Spontaneous Urticaria, Angioedema

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial