Study of IFN-K in Dermatomyositis

Phase 2

Withdrawn

• Conditions: Dermatomyositis

• Registration Number: NCT02980198
• Lead Sponsor: Neovacs

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-25
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-02
• Study Start: 2017-05-03
• Status Verified: 2019-12
• Primary Completion: 2019-12-11
• Study Completion: 2019-12-11
• Last Update Submitted: 2019-12-31
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in the expression of IFN-induced genes at Week 48	Week 48

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Research site; 🇨🇭 Lausanne, Switzerland

Charité - Universitätsmedizin Berlin Rudolf- Virchow- Haus; 🇩🇪 Berlin, Germany