HIDRA04 is a double-blind randomized study aiming to the comparison of the efficacy of MABp1 (Xilonix), a fully humanized antibody targeting interleukin-1alpha, over placebo for patients with severe HS not eligible for treatment with adalimumab. This indication is an unmet need since almost 50% of patients have primary or secondary failure to adalimumab, already licensed for HS.
Study title: “A double-blind, randomised, placebo-controlled clinical trial of the safety and efficacy of MABp1, a- first-in-class true human antibody targeting interleukin-1alpha, in patients with hidradenitis suppurativa not eligible for adalimumab”.
EudraCT number: 2015-002321-20
National Organization for Medicines Approval: IS 48/15
National Ethics Committee Approval: 46/15
ClinicalTrials.gov NCT: 02643654
Duration: November 2015 to February 2017
Study phase: II
Number of Study sites: 1
Total number of enrolled patients: 20