Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

Summary

This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.

Timeline

Start

2015-07-15

Primary completion

2016-11-02

Completion

2017-06-12

Outcome

Met primary endpoint

paper 30%, 51%, and 42% of the patients treated with 24 mg, 72 mg, and 240 mg, respectively, of ligelizumab had complete control of hives PMID 31577874 ↗

paper as compared with 26% of the patients in the omalizumab group PMID 31577874 ↗

Publications

• Metz M, Bernstein JA, Gimenez-Arnau AM, Hide M, Maurer M, Sitz K, Soong W, Sussman G, Hua E, Barve A, Barbier N, Balp MM, Severin T. Ligelizumab improves angioedema, disease severity and quality-of-life in patients with chronic spontaneous urticaria. World Allergy Organ J. 2022 Nov 15;15(11):100716. doi: 10.1016/j.waojou.2022.100716. eCollection 2022 Nov.
• Maurer M, Gimenez-Arnau A, Bernstein JA, Chu CY, Danilycheva I, Hide M, Makris M, Metz M, Savic S, Sitz K, Soong W, Staubach P, Sussman G, Barve A, Burciu A, Hua E, Janocha R, Severin T. Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one-year extension study. Allergy. 2022 Jul;77(7):2175-2184. doi: 10.1111/all.15175. Epub 2021 Nov 22.
• Maurer M, Gimenez-Arnau AM, Sussman G, Metz M, Baker DR, Bauer A, Bernstein JA, Brehler R, Chu CY, Chung WH, Danilycheva I, Grattan C, Hebert J, Katelaris C, Makris M, Meshkova R, Savic S, Sinclair R, Sitz K, Staubach P, Wedi B, Loffler J, Barve A, Kobayashi K, Hua E, Severin T, Janocha R. Ligelizumab for Chronic Spontaneous Urticaria. N Engl J Med. 2019 Oct 3;381(14):1321-1332. doi: 10.1056/NEJMoa1900408.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ligelizumab	Monoclonal antibody	24 mg	Subcutaneous
Subject	Ligelizumab	Monoclonal antibody	72 mg	Subcutaneous
Subject	Ligelizumab	Monoclonal antibody	120 mg	Subcutaneous
Subject	Ligelizumab	Monoclonal antibody	240 mg	Subcutaneous
Comparator	Omalizumab	Monoclonal antibody	300 mg	Subcutaneous

Indications