NCT05024058

Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines

A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This was a placebo controlled, phase 3 study designed to evaluate the efficacy and safety of ligelizumab in participants with chronic inducible urticaria who are inadequately controlled with H1-antihistamines

Detailed description

There are currently no approved therapies for patients with CINDU who remain symptomatic despite treatment with H1-antihistamines. The purpose of this study was to establish efficacy and safety of ligelizumab (QGE031) over placebo in participants with chronic inducible urticaria (CINDU) who remain symptomatic despite treatment with H1 antihistamine.

Conditions

• Chronic Inducible Urticaria

Interventions

Type	Name	Description
DRUG	Ligelizumab	Ligelizumab treated groups and arms
OTHER	Placebo	Placebo treated groups and arms

Timeline

• Start date: 2021-11-16
• Primary completion: 2022-08-09
• Completion: 2022-08-09
• First posted: 2021-08-27
• Last updated: 2024-06-18
• Results posted: 2023-09-15

Locations

24 sites across 9 countries: United States, Australia, Greece, Hungary, Russia, Slovakia, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study