Clinical trial NCT02980198: Study of IFN-K in Dermatomyositis
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Dermatomyositis
Lead sponsor: Neovacs
Sponsor class: INDUSTRY
First posted: 2016-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the expression of IFN-induced genes at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Number of subjects with treatment related adverse events
timeFrame: Week 48
measure: Total improvement score from IMAC Core Set Measures (CSM) following Aggarwal et al (2017) recommendations
timeFrame: Week 0, Week 12, Week 24, Week 36, Week 48
measure: Others tools: Cutaneous Disease Area and Severity Index (CDASI)
timeFrame: Week 0, Week 12, Week 24, Week 36, Week 48
measure: Others tools: Manual Muscle Testing (MMT5)
timeFrame: Week 0, Week 12, Week 24, Week 36, Week 48
measure: Others tools: Accelerometer
timeFrame: Week 0, Week 12, Week 24, Week 36, Week 48
measure: Others tools:Dermatology Life Quality Index (DLQI score)
timeFrame: Week 0, Week 12, Week 24, Week 36, Week 48
measure: Immune response induced by IFN-K as measured by antibodies production
timeFrame: Week 48
Other outcomes:
Locations:
city: Lille
country: France
facility: Research site
city: Marseille
country: France
facility: Research site
city: Paris
country: France
facility: Research site
city: Paris
country: France
facility: Research site
city: Strasbourg
country: France
facility: Research site
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin Rudolf- Virchow- Haus
city: Padova
country: Italy
facility: Research site
city: Lausanne
country: Switzerland
facility: Research site
Study officials:
References: