Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients

Conditions

• Chronic Spontaneous Uriticaria

Eligibility Criteria

Sex

ALL

Age

12 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Omalizumab — BIOLOGICAL
  Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
• Placebo — OTHER
  Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.

Study Details

This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.

Key Dates

Start date

Dec 31, 2014

Status verified

Sep 2016

Primary completion

Dec 31, 2015

Completion

Dec 31, 2015

Study Design

Enrollment

218 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Omalizumab 300 mg
  Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
• Experimental: Omalizumab 150 mg
  Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
• Placebo Comparator: Placebo
  Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.

Primary Outcome Measure

Change From Baseline in the Weekly Itch Severity Score at Week 12 [ Time Frame: Baseline to Week 12 ]