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CHRONIC SPONTANEOUS URTICARIAPhase 4SUNRISENCT02550106

Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment

A Phase 4 study testing OMALIZUMAB in people with CHRONIC SPONTANEOUS URTICARIA, run by Novartis Pharmaceuticals at 29 sites in France.

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

Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
CHRONIC SPONTANEOUS URTICARIA
What is being tested?
OMALIZUMAB
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
29 sitesFrance
Study dates
22 Apr 2015to 11 Jan 2016
Phase
Phase 4
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

  • Male or female patients aged between 18 and 75 years.
  • Diagnosis of CSU for ≥ 6 months and an inadequate response to nsH1 antihistamines at the time of the request, as defined by the following:
  • The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment, despite current use of H1 antihistamine therapy during this time period.
  • Weekly UAS7 score (range 0 to 42) 16 and UCT score (range 0 to 16) < 8 prior to enrollment (Day 1)
  • Current use of an H1 antihistamine for CSU on the day of the initial visit and Day
  • Informed consent

Who cannot join

  • Treatment with an investigational agent within 30 days before enrollment.
  • Routine (daily or every other day during 5 or more consecutive days) doses of the following medications within 30 days prior to Day -7: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
  • Intravenous (i.v.) immunoglobulin G or plasmapheresis within 30 days prior to Day -7
  • Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -7.
  • Any H2 antihistamine use within 7 days prior to Day -7.
  • Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to Day 7.
Show all 9Show fewer
  • Concomitant use of cyclosporine or any other immunosuppressive agent.
  • Hypersensitivity to omalizumab or any component of the formulation.
  • History of anaphylactic shock.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

France29 sites

  • Novartis Investigative Site

    Angers, 49933

  • Novartis Investigative Site

    Argenteuil, 95107

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Bobigny, 93009

  • Novartis Investigative Site

    Bordeaux, 33075

  • Novartis Investigative Site

    Châlons-en-Champagne, 51005

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

  • Novartis Investigative Site

    Dijon, 21034

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    Lille, 59000

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Limoges, Haute Vienne, 87000

  • Novartis Investigative Site

    Lyon, 69317

  • Novartis Investigative Site

    Marseille, 13885

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Nantes, 44035

  • Novartis Investigative Site

    Nice, 06202

  • Novartis Investigative Site

    Nîmes, 30029

  • Novartis Investigative Site

    Paris, Cedex 10, 75475

  • Novartis Investigative Site

    Paris, 75014

  • Novartis Investigative Site

    Paris, 75877

  • Novartis Investigative Site

    Quimper, 29000

  • Novartis Investigative Site

    Reims, 51090

  • Novartis Investigative Site

    Rennes, 35033

  • Novartis Investigative Site

    Rouen, 76031

  • Novartis Investigative Site

    Saint-Etienne, 42055

  • Novartis Investigative Site

    Toulon, Val De Marne, 83800

  • Novartis Investigative Site

    Toulouse, 31400

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: A Phase IV, Multicenter, Single-arm and Open-label Study With Omalizumab (Xolair®) in Chronic Spontaneous Urticaria (CSU) Patients Who Remain Symptomatic Despite Antihistamine (H1) Treatment

Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.

Being tested
OMALIZUMAB
Keywords
CHRONIC SPONTANEOUS URTICARIA, OMALIZUMAB, URTICARIA CONTROL TEST, IGE025
Medical subject headings
Chronic Urticaria

What participants receive

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

  • OMALIZUMABDrug

    sub cutaneous injections of 300 mg every 4 weeks until Week 8.

Study groups in NCT02550106
Study groupRoleWhat they receive
OMALIZUMABExperimentalsub cutaneous injections of 300 mg every 4 weeks until Week 8.
Receives: Drug: OMALIZUMAB

What is being measured

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

  1. Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12

    Number of participants with an Urticaria Control Test score of greater than or equal to 12 at Week 12

    The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.

    Measured: WEEK 12

Secondary outcomes (11)

  1. Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema

    2 patients with angioedema status were missing at baseline and not included

    Measured: WEEK 12

  2. CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema

    A total score of UAS7 is calculated by adding for 7 days the daily UAS. The UAS7 is the sum of the daily UAS over 7 days before baseline and W12. The UAS7 score ranges from 0 to 42 with higher scores reflecting higher activity of the disease.

    Scores were categorized into five diseases states : urticaria-free (score =0), well-controlled (scores 1-6), mild (scores 7-15), moderate (scores 16-27) and severe urticaria (scores 28-42).

    Measured: baseline and week 12

  3. Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12

    The UCT is a questionnaire collecting retrospective information over the last 4 weeks before baseline and W12.

    The UCT score ranges from 0 to 16 with higher scores reflecting lower control of the disease.

    A score of ≥12 indicates well-controlled urticaria.

    Measured: baseline and week 12

  4. Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema

    The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.

    Measured: week 16

  5. Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema

    The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.

    Measured: week 20

  6. Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema

    The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control

    Measured: week 24

  7. Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema

    The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.

    Measured: week 28

  8. The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire

    The Cu-QoL is a questionnaire collecting retrospective information over the last 2 weeks before baseline and W12.

    The CU-QoL total score is transformed to range from 0 to 100, with higher scores indicating worse Health Related Quality of life.

    Measured: baseline and week 12

  9. The Angioedema Quality of Life (AE-QoL)

    The angioedema Quality of Life Questionnaire is a valuable tool to assess changes of QoL impairment in angioedema patients.

    The results of all the answered questions are summed up and transferred to a scale ranging from 0 to 100, with higher scores indicative of a higher QoL impairment

    Measured: baseline and week 12

  10. The Dermatology Life Quality Index (DLQI)

    The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).

    Measured: baseline and week 12

  11. Angioedema Activity Using the Angioedema Activity Score (AAS)

    The Angioedema Activity Score (AAS) was completed by patients on a daily basis. The AAS is a validated questionnaire to determine the severity and impact of the angioedema episode. Te daily AAS values are added over 7 days before baseline and W12. Weekly AAS (AAS7) scores range from 0 to 105, with higher scores indicative of a higher disease activity.

    Measured: baseline and week 12

Timeline

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

  1. First posted15 Sep 2015 (estimated)
  2. Study start22 Apr 2015
  3. Primary completion11 Jan 2016
  4. Study completion11 Jan 2016

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02550106
Sponsor's protocol ID
CIGE025EFR02
Acronym
SUNRISE
Status last verified
Feb 2020
First submitted
9 Mar 2015
Last updated
25 Feb 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing OMALIZUMAB in people with CHRONIC SPONTANEOUS URTICARIA, run by Novartis Pharmaceuticals at 29 sites in France.

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 9 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 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in France. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 25 Feb 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?

Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12 (time frame: WEEK 12). 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 NCT02550106.

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 25 Feb 2020.

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