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Completed

NCT Number: NCT02550106

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

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

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Key information

Conditions

Chronic Spontaneous Urticaria Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Paris, Cedex 10, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Concomitant use of cyclosporine or any other immunosuppressive agent.
  • Hypersensitivity to omalizumab or any component of the formulation.
  • History of anaphylactic shock.

Treatment and study plan

Omalizumab

Drug

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

Primary outcomes

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

    Time frame: WEEK 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.

Secondary outcomes

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

    Time frame: WEEK 12

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

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

    Time frame: baseline and week 12

    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).

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

    Time frame: 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.

  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

    Time frame: week 16

    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.

  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

    Time frame: week 20

    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.

  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

    Time frame: week 24

    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

  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

    Time frame: week 28

    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.

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

    Time frame: baseline and week 12

    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.

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

    Time frame: baseline and week 12

    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

  10. The Dermatology Life Quality Index (DLQI)

    Time frame: baseline and week 12

    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).

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

    Time frame: baseline and week 12

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: SUNRISE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2015
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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