MABp1 IN HIDRADENITIS SUPPURATIVA REFRACTORY TO ADALIMUMAB

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder. Although adalimumab is recently licensed for moderate to severe HS, many cases fail to respond or relapse during treatment. Favorable outcomes from a recently conducted double-blind randomized clinical study on the efficacy of anakinra, one interleukin(IL)-1alpha blocker, in hidradenitis suppurativa (HS), led to validate the efficacy of MABp1, a true human antiIL-1α antibody in these cases.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Evangelos J. Giamarellos-Bourboulis, M.D.
• Collaborator: Hellenic Institute for the Study of Sepsis

Criteria

Inclusion Criteria:

• Written informed consent provided by the patient

• Age equal to or more than 18 years

• Diagnosis of hidradenitis suppurativa (HS)

• HS of Hurley II or III stage disease or rapidly progressive HS of Hurley I stage

• Presence of at least 3 inflamed nodules consistent with HS in the body

• At least one of the following: a) previous failure of treatment with any anti-TNF regimen; b) previous relapse under treatment with any anti-TNF regimen; c) unwillingness to receive subcutaneous adalimumab treatment

Note: Since rapidly progressive HS of Hurley I stage as defined below is not a licensed indication for adalimumab, these patients can be enrolled irrespective or not of a history of previous adalimumab treatment.

Exclusion Criteria:

• History of systemic lupus erythematosus

• Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).

• History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.

• Administration of any live (attenuated) vaccine over the last 4 weeks

• History of recurrent vein thrombosis or embolism compatible with anti-cardiolipin syndrome

• Any present serious bacterial infection namely pneumonia, endocarditis, acute pyelonephritis and intrabdominal infection. These patients can be enrolled once the attending physicians confirm cure by the infection

• Hepatic dysfunction defined as any value of transaminases, of γ-glutamyl transpeptidase or of bilirubin> 2 x upper normal limit

• History of haematological or solid tumor malignancy, arterial hypertension, liver cirrhosis, HIV infection, and hepatitis virus B or C infection

• History of episodes mimicking demyelinating disorders or a definite diagnosis of multiple sclerosis

• Any creatinine value above 1.5 mg/dl

• Intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1mg/kg for the last three weeks

• Neutropenia defined as <1000 neutrophils/mm3

• Pregnancy or lactation

• History of tuberculosis (latent or active). This will be excluded according to the procedure defined in the screening of patients (see below)

• Major surgery within 28 days prior to Day 0

• It is explicitly stated that intake of antimicrobials for HS is not an exclusion criterion