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NCT Number: NCT02392624

A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48 weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg) every 4 weeks (Q4W), participants responding to omalizumab will be randomized at a 3:2 ratio (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a further 24 weeks.

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Key information

Conditions

Urticaria Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Allergy and Asthma Relief Experts, Granada Hills, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of CIU refractory to H1 antihistamines at baseline
  • Presence of itch and hives for at least 8 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine treatment (up to four times the approved dose) during this time period
  • UAS7 score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to baseline
  • Participants must have been on a non-sedating H1 antihistamine treatment (up to four times the approved dose) for CIU for at least 3 consecutive days immediately prior to screening visit with continued current use on the day of the initial screening visit
  • CIU diagnosis for ≥ 6 months
  • Willing and able to complete a daily symptom eDiary for the duration of the study

Exclusion criteria

  • Treatment with an investigational agent within 30 days of the initial screening visit
  • Body weight less than 20 kilograms
  • Clearly defined underlying etiology for chronic urticarias other than CIU
  • Evidence of a parasitic infection
  • Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch
  • Previous treatment with omalizumab within 1 year prior to the initial screening visit
  • Participants may not have taken during treatment period or have been taking within 30 days before the initial screening visit any of the following medications or treatments:

regular (daily/every other day during 5 or more consecutive days) systemic corticosteroids, hydroxychloroquine, methotrexate, mycophenolate, cyclosporine, cyclophosphamide, intravenous immunoglobulin G or plasmapheresis

  • Regular (daily/every other day) oral doxepin use within 14 days prior to the initial screening visit
  • Pregnant or lactating women, or women intending to become pregnant during the study

Treatment and study plan

Omalizumab

Drug

Omalizumab 300 mg administered SC Q4W.

Other names: Xolair; RO5489789

Placebo

Drug

Placebo matched to omalizumab administered SC Q4W.

Primary outcomes

  1. Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by Urticaria Activity Score Over 7 Days (UAS7) (Clinical Worsening: UAS7 Greater Than or Equal to [>/=] 12, Maintained for At Least 2 Consecutive Weeks)

    Time frame: From randomization (Week 24) to Week 48

    Urticaria activity score (UAS) is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals (hives) per 24 hours and the intensity of the pruritus (itch). The total UAS score (sum of the wheal and pruritus scores) ranges from 0 to 6. Due to variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 >/=12 for at least 2 consecutive weeks post-randomization between Weeks 24 and 48.

Secondary outcomes

  1. Time to Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 >/=12, Maintained for At Least 2 Consecutive Weeks)

    Time frame: From randomization (Week 24) to Week 48

    The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Time to clinical worsening in CIU was defined as the number of weeks from the first double-blind treatment to the first two-week interval with UAS7 >/=12 for both weeks. If clinical worsening did not occur, time to clinical worsening was censored at the end of the last week for which the UAS7 score was not missing and less than (<) 12, prior to last randomized dose + 4 weeks, or the first open-label transition dose, whichever was earlier. Median time to clinical worsening was estimated using Kaplan-Meier analysis and corresponding 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.

  2. Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 Greater Than [>] 6, Maintained for At Least 2 Consecutive Weeks)

    Time frame: From randomization (Week 24) to Week 48

    The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 >6 for at least 2 consecutive weeks post-randomization between weeks 24 and 48.

  3. Change From Randomization (Week 24) to Week 48 in UAS7 Among Participants Who Received Total 48 Weeks Treatment With Omalizumab

    Time frame: Week 24 (randomization) and Week 48

    The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change in score (Week 48 score minus Week 24 score) indicates improvement.

  4. Retreatment Efficacy: Change From Time of Retreatment to 12 Weeks After Retreatment in UAS7 Among Participants Randomized to Placebo and Who Were Retreated With Open-Label Omalizumab After Randomization

    Time frame: At start of retreatment (any time between Weeks 24 and Week 48) and 12 weeks after retreatment (up to Week 60)

    The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change in score indicates improvement.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

XTEND-CIU (Xolair Treatment Efficacy of Longer Duration in Chronic Idiopathic Urticaria): A Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Omalizumab Through 48 Weeks in Patients With Chronic Idiopathic Urticaria

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 19, 2015
Registry last updated
Mar 29, 2018

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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