Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

Summary

The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.

Timeline

Start

2018-02-26

Primary completion

2019-05-27

Completion

2020-01-27

Outcome

Missed primary endpoint

paper The study did not meet the primary endpoint, perhaps due, in part, to an unexpectedly high HiSCR placebo response rate of 47.1%. PMID 41081529 ↗

release “While we were very disappointed about missing our primary endpoint in the SHINE study” inflarx.de ↗

Publications

• Giamarellos-Bourboulis EJ, Jemec GBE, Prens EP, Riedemann NC, Otto I, Weisman J, Pulka G, Nowicki RJ, Kantardjiev V, Pinter A, Thomsen SF, Berneman D, Kanni T, Alavi A, Breno B, Gooderham M, Stone M, Anadkat MJ, Katoulis A, Papakonstantis M, Becherel PA, Szepietowski JC, van der Zee HH, Zouboulis CC, Sayed CJ. Vilobelimab to improve clinical outcomes in moderate-to-severe hidradenitis suppurativa through an adjunctive effect on draining tunnels: results of the SHINE double-blind placebo-controlled randomized trial. Br J Dermatol. 2026 Jan 27;194(2):254-263. doi: 10.1093/bjd/ljaf398.
• Prens LM, Ardon CB, van Straalen KR, van der Zee HH, Seelen MAJ, Laman JD, Prens EP, Horvath B, Damman J. No Evident Systemic Terminal Complement Pathway Activation in Hidradenitis Suppurativa. J Invest Dermatol. 2021 Dec;141(12):2966-2969.e1. doi: 10.1016/j.jid.2021.03.037. Epub 2021 Jul 9. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	vilobelimab	Monoclonal antibody	400 mg	Intravenous
Subject	vilobelimab	Monoclonal antibody	800 mg	Intravenous
Subject	vilobelimab	Monoclonal antibody	1200 mg	Intravenous

Indications