Study of IFN-K in Dermatomyositis

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

Official Title
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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

Conditions
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Dermatomyositis

Intervention / Treatment
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* Biological: IFN-Kinoid
* Other: Placebo
* Other: ISA 51


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IFN-Kinoid<br>IFN-Kinoid + ISA 51 | Biological: IFN-Kinoid<br>* IM administration<br>Other: ISA 51<br>* adjuvant<br>|
| Placebo Comparator: Placebo<br>Placebo + ISA 51 | Other: Placebo<br>* IM administration<br>Other: ISA 51<br>* adjuvant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the expression of IFN-induced genes at Week 48 |  | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Others tools: Cutaneous Disease Area and Severity Index (CDASI) |  | Week 0, Week 12, Week 24, Week 36, Week 48 | 
| 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 | 
| Immune response induced by IFN-K as measured by antibodies production |  | Week 48 |