Completed study

Official 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

Brief Description

HIDRA04 is a double-blind randomized study aiming to the comparison of the efficacy of MABp1 (Bermekimab), 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.

Status: Completed
Study Type: Interventional (Clinical Trial)
Study phase: II
Study sites: 2 sites in Greece
Actual enrolment: 20 participants Identifier: NCT02643654
EudraCT number: 2015-002321-20
National Organization for Medicines Approval: IS 48-15
National Ethics Committee Approval: 46/15

Study Start: December 2015
Study Completion: February 2017

Condition/Disease studied: Hidradenitis Suppurativa
Keywords: interleukin-1alpha

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