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

Conditions

• Urticaria

Eligibility Criteria

Sex

ALL

Age

12 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Omalizumab — DRUG
  Omalizumab 300 mg administered SC Q4W.
• Placebo — DRUG
  Placebo matched to omalizumab administered SC Q4W.

Study Details

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.

Key Dates

Start date

May 18, 2015

Status verified

Mar 2018

Primary completion

Mar 9, 2017

Completion

Mar 9, 2017

Study Design

Enrollment

206 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Omalizumab
  Participants will receive open-label omalizumab treatment at 300 mg SC Q4W for 24 weeks. After 24 weeks open-label treatment, eligible participants will be randomized to receive omalizumab treatment at 300 mg SC Q4W for next 24 weeks (up to Week 48). Participants randomized to omalizumab may, at the discretion of the investigator, be transitioned from blinded study drug to open-label omalizumab at 300 mg SC Q4W if they experience clinically significant worsening in their CIU (as judged by the investigator). Participants who are transitioned to open-label omalizumab will continue to receive open-label omalizumab as study drug until Week 48.
• Placebo Comparator: Placebo
  Participants will receive open-label omalizumab treatment at 300 mg SC Q4W for 24 weeks. After 24 weeks open-label treatment, eligible participants will be randomized to receive placebo SC Q4W for next 24 weeks (up to Week 48). Participants randomized to placebo may, at the discretion of the investigator, be transitioned from blinded study drug to open-label omalizumab at 300 mg SC Q4W if they experience clinically significant worsening in their CIU (as judged by the investigator). Participants who are transitioned to open-label omalizumab will continue to receive open-label omalizumab as study drug until Week 48.

Primary Outcome Measure

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 ]

Locations (40)

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