Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy

Phase 3 Completed 91 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.

Timeline

Start: 2013-01-23
Primary completion: 2014-05-09
Completion: 2014-05-09

Outcome

Met primary endpoint

paper Omalizumab was superior to placebo in improving CU-Q2oL scores at week 28 (P < 0.001). PMID 27010957 ↗

Publications

Staubach P, Metz M, Chapman-Rothe N, Sieder C, Brautigam M, Canvin J, Maurer M. Effect of omalizumab on angioedema in H1 -antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial. Allergy. 2016 Aug;71(8):1135-44. doi: 10.1111/all.12870. Epub 2016 Mar 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omalizumab	Monoclonal antibody	300 mg	Subcutaneous