Study of IFN-K in Dermatomyositis

A Phase IIa, Single Blind, Randomized, Study to Evaluate the Safety, the Immunogenicity, and the Clinical and Biological Efficacy of IFNα-Kinoid (IFN-K) in Adult Subjects With Dermatomyositis

This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα antibodies (immune response) in adult subjects with dermatomyositis

Inclusion Criteria:

• Patient newly diagnosed or relapsing with "definite" or "probable" dermatomyositis based on ENMC criteria (2004)
• Patient requiring corticosteroids (CS) at a dose of 1 mg/Kg and ≤ 70 mg of prednisone equivalent/day or currently receiving CS at a dose of 1 mg/Kg and ≤ 70 mg of prednisone equivalent/day
• Is a male or female, aged between 18 and 65 years, inclusive, at the time of the screening visit
• study patient and his/her partner of child bearing potential has to use effective method of contraception

Exclusion Criteria:

• Is high-risk human papilloma virus (HPV) positive by (RT-PCR) on a cervical swab
• Has cytological abnormalities ≥ HSIL on a cervical swab
• Is positive for autoantibodies anti-NXP2, TIF1ɤ, MDA5 associated with severe pulmonary disease or anti-synthetase antibodies
• Is positive for any malignancy or has a history of any malignancy
• Has received IV pulse dose CS (≥ 250 mg prednisone equivalent/day)
• Has received intravenous immunoglobulin (IVIg)
• Has received potent immunosuppressive drugs such as cyclophosphamide, methotrexate, azathioprine, mycophenolate, cyclosporine A, oral tacrolimus
• Has received abatacept, anifrolumab, belimumab, TNF antagonists or another registered or investigational biological therapy
• Has received anti-B-cell therapy (e.g. rituximab, epratuzumab)
• Has received any live vaccine
• Has used any investigational or non-registered product , or any investigational or non-registered vaccine
• Has inflammatory joint or skin disease other than dermatomyositis that may interfere with study assessments
• Has frequent recurrences of oral or genital herpes simplex lesions
• Is at high risk of significant infection and/or has any current signs or symptoms of infection at entry or has received intravenous antibiotics