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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ligelizumab | Monoclonal antibody | — | Subcutaneous |