Dermatomyositis
Conditions
Brief summary
This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα antibodies (immune response) in adult subjects with dermatomyositis
Interventions
BIOLOGICALIFN-Kinoid
IM administration
OTHERPlacebo
IM administration
OTHERISA 51
adjuvant
Sponsors
Neovacs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the expression of IFN-induced genes at Week 48 | Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Others tools: Manual Muscle Testing (MMT5) | Week 0, Week 12, Week 24, Week 36, Week 48 |
| Others tools: Accelerometer | Week 0, Week 12, Week 24, Week 36, Week 48 |
| Others tools:Dermatology Life Quality Index (DLQI score) | Week 0, Week 12, Week 24, Week 36, Week 48 |
| Others tools: Cutaneous Disease Area and Severity Index (CDASI) | Week 0, Week 12, Week 24, Week 36, Week 48 |
| Number of subjects with treatment related adverse events | Week 48 |
| Total improvement score from IMAC Core Set Measures (CSM) following Aggarwal et al (2017) recommendations | Week 0, Week 12, Week 24, Week 36, Week 48 |
| Immune response induced by IFN-K as measured by antibodies production | Week 48 |
Countries
France, Germany, Italy, Switzerland
Outcome results
None listed