drugset / Trial / NCT05024058

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

NCT05024058 ↗

Phase 3 Terminated 39 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2021-11-16
Primary completion
2022-08-09
Completion
2022-08-09

Outcome

Outcome not reported

Stopped: “Phase III PEARL studies (CQGE031C2302 and CQGE031C2303) with ligelizumab met their primary endpoint of superiority vs placebo at Week 12 for treatment of CSU, but not versus omalizumab. Decision to discontinue was not based on safety concerns.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ligelizumab Monoclonal antibody — Subcutaneous