Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Summary

Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.

Timeline

Start

2017-06-14

Primary completion

2018-07-19

Completion

2018-09-21

Outcome

Met primary endpoint

paper Nemolizumab (30 mg) reduced EASI scores versus placebo at week 24 (-68.8% vs -52.1%, P = .016); PMID 31449914 ↗

release “this Phase 2b late-breaking presentation and to be able to report that nemolizumab met all study endpoints in treatment of moderate-to-severe atopic dermatitis” galderma.com ↗

Publications

• Silverberg JI, Pinter A, Pulka G, Poulin Y, Bouaziz JD, Wollenberg A, Murrell DF, Alexis A, Lindsey L, Ahmad F, Piketty C, Clucas A. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020 Jan;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013. Epub 2019 Aug 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nemolizumab	Monoclonal antibody	10 mg	Subcutaneous
Subject	Nemolizumab	Monoclonal antibody	30 mg	Subcutaneous
Subject	Nemolizumab	Monoclonal antibody	90 mg	Subcutaneous

Indications