Study of IFN-K in Dermatomyositis

Neovacs

Status and phase: Withdrawn; Phase 2

Conditions: Dermatomyositis

Treatments: Biological: IFN-Kinoid; Other: Placebo; Other: ISA 51

Study type: Interventional

Funder types: Industry

Identifiers

NCT02980198

IFN-K-005-DM

2016-000137-52 (EudraCT Number)

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

IFN-Kinoid

Experimental group

Description:

IFN-Kinoid + ISA 51

Treatment:

Biological: IFN-Kinoid

Other: ISA 51

Placebo

Placebo Comparator group

Description:

Placebo + ISA 51

Treatment:

Other: Placebo

Other: ISA 51