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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02550106
Phase
PHASE4
Status
Completed

Conditions

  • CHRONIC SPONTANEOUS URTICARIA

Eligibility Criteria

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

Interventions

  • OMALIZUMAB — DRUG
    sub cutaneous injections of 300 mg every 4 weeks until Week 8.

Study Details

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

Key Dates

Start date
Apr 22, 2015
Status verified
Feb 2020
Primary completion
Jan 11, 2016
Completion
Jan 11, 2016

Study Design

Enrollment
136 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OMALIZUMAB
    sub cutaneous injections of 300 mg every 4 weeks until Week 8.

Primary Outcome Measure

Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12 [ Time Frame: WEEK 12 ]

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