CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
Ligelizumab +1 moredrug
Likely dose
Ligelizumab 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03437278
NCT03437278Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Dose-finding Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in Adolescent Patients With Chronic Spontaneous Urticaria (CSU)

Novartis Pharmaceuticals·interventional·Posted Feb 19, 2018·Updated Jan 13, 2026

In Brief

A Phase 2 clinical trial evaluating Ligelizumab and Placebo for Chronic Spontaneous Urticaria. Completed, enrolled 49 participants across 20 sites in 10 countries.

Detailed Summary

This clinical study was designed to evaluate the pharmacokinetics, safety and efficacy of ligelizumab in children from 12 to \< 18 years of age, with chronic spontaneous urticaria (CSU). The participants were treated with ligelizumab as an add-on therapy to approved doses of H1 antihistamines (H1AH) following the guideline on treatment of CSU.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spontaneous Urticaria
CountriesArgentina, Belgium, Canada, Germany, Hungary, India, Russia, Spain, Taiwan, Turkey (Türkiye)
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 19, 2018
Enrollment StartAug 1, 2018
Primary CompletionOct 23, 2020
Study CompletionFeb 3, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.4 years ago

Interventions

Ligelizumabdrug

Ligelizumab comes in 120 mg per 1 ml liquid vials. Participants received one injection every 4 weeks at a dose of 120 mg or 24 mg, high and low doses respectively.

Placebodrug

Placebo 0 mg per 1 ml liquid injection once every 4 weeks.