Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03328897
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Spontaneous Urticaria

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    injection of 150mg or 300 mg
  • Placebo — DRUG
    Injection of placebo

Study Details

The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.

Key Dates

First listed
Nov 1, 2017
Start date
Apr 26, 2017
Status verified
Oct 2020
Primary completion
Jul 23, 2019
Completion
Sep 24, 2019

Study Design

Enrollment
418 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab 300mg
    patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
  • Experimental: Omalizumab 150mg
    patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)
  • Placebo Comparator: Placebo
    patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)

Primary Outcome Measure

Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment [ Time Frame: Baseline, Week 12 ]

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