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Chronic Spontaneous UrticariaPhase 3X-ACTNCT01723072

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

A Phase 3 study testing Omalizumab in people with Chronic Spontaneous Urticaria and Angioedema, run by Novartis Pharmaceuticals at 25 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Spontaneous Urticaria, Angioedema
What is being tested?
Omalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
91 participants
Where
25 sitesGermany
Study dates
23 Jan 2013to 9 May 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Germany25 sites

  • Novartis Investigative Site

    Aachen, 52074

  • Novartis Investigative Site

    Augsburg, 86179

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bochum, 44791

  • Novartis Investigative Site

    Bonn, 53105

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

  • Novartis Investigative Site

    Darmstadt, 64283

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Düsseldorf, 40225

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Gera, 07548

  • Novartis Investigative Site

    Halle, 06120

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Homburg, 66421

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68305

  • Novartis Investigative Site

    München, 81377

  • Novartis Investigative Site

    München, 81675

  • Novartis Investigative Site

    Oldenburg, 26133

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053

  • Novartis Investigative Site

    Selters, 56242

  • Novartis Investigative Site

    Wiesbaden, 65199

Other trials in Germany

About this study

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.

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.

Read the 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.

Being tested
Omalizumab, Placebo
Keywords
Chronic spontanous urticaria, refractory CSU, Angioedema
Medical subject headings
Chronic Urticaria, Angioedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmalizumabBiological

    Also called IGE025

    Humanized monoclonal antibody against human IgE

  • PlaceboDrug

    Also called Placebo for Omalizumab

    Placebo to omalizumab

Study groups in NCT01723072
Study groupRoleWhat they receive
1 OmalizumabExperimentalomalizumab once a month via subcutaneous injection.
Receives: Biological: Omalizumab
2 PlaceboPlacebo comparatorplacebo of omalizumab once a month via subcutaneous injection
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    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.

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

Secondary outcomes (15)

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

    Measured: Baseline, week 28; and the follow-up period (weeks 29-36)

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

    Measured: Baseline to week 28

  3. 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

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

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

    data points per group

    Measured: week -2 to -1

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

    data points per group

    Measured: weeks 25 to 28

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

    data points per group

    Measured: weeks 33 to 36

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

    data points per group

    Measured: weeks -2 to -1

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

    data points per group

    Measured: weeks 25 to 28

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

    data points per group

    Measured: weeks 33 to 36

  10. 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

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

  11. Rescue Medication During the Treatment Period

    Measured: baseline to 28 weeks

  12. Days of Rescue Medication During the Treatment Period

    data points per group

    Measured: baseline to 28 weeks

  13. Days of Rescue Medication During the Follow-up Period

    data points per group

    Measured: weeks 33 to 36

  14. 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

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

  15. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2012 (estimated)
  2. Study start23 Jan 2013
  3. Primary completion9 May 2014
  4. Study completion9 May 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01723072
Sponsor's protocol ID
CIGE025EDE16
Acronym
X-ACT
Status last verified
Aug 2020
First submitted
5 Nov 2012
Last updated
9 Sep 2020
Data monitoring committee
No

Publications

  • 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.

    PubMed 27010957

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omalizumab in people with Chronic Spontaneous Urticaria and Angioedema, run by Novartis Pharmaceuticals at 25 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01723072, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.

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