A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

Conditions

• Chronic Spontaneous Urticaria

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ligelizumab — BIOLOGICAL
  Liquid in vial
• Omalizumab — BIOLOGICAL
  Lyophilized powder for solution in vial
• Placebo — OTHER
  Liquid in vial

Study Details

The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,072 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines. This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

Key Dates

Start date

Oct 17, 2018

Status verified

Jul 2023

Primary completion

Jul 16, 2021

Completion

Jun 14, 2022

Study Design

Enrollment

1,072 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ligelizumab 120 mg
  Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
• Experimental: Ligelizumab 72 mg
  Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
• Active Comparator: Omalizumab 300 mg
  Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
• Placebo Comparator: Placebo
  Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48

Primary Outcome Measure

Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects [ Time Frame: Baseline, Week 12 ]

Locations (30)

Find similar trials in Gilbert, AZ

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