Study of IFN-K in Dermatomyositis

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

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

Study Overview

• Status: Withdrawn
• Conditions: Dermatomyositis
• Intervention / Treatment: Biological: IFN-Kinoid; Other: ISA 51; Other: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Research Site
  • Marseille, France, 13354
    • Research Site
  • Paris, France, 75010
    • Research Site
  • Paris, France, 75013
    • Research Site
  • Strasbourg, France, 67098
    • Research Site
• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin Rudolf- Virchow- Haus
• Italy
  • Padova, Italy, 35128
    • Research Site
• Switzerland
  • Lausanne, Switzerland, 1011
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IFN-Kinoid; IFN-Kinoid + ISA 51	Biological: IFN-Kinoid; IM administration; Other: ISA 51; adjuvant
PLACEBO_COMPARATOR: Placebo; Placebo + ISA 51	Other: ISA 51; adjuvant; Other: Placebo; IM administration

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Neovacs

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2017
• Primary Completion (ACTUAL): December 11, 2019
• Study Completion (ACTUAL): December 11, 2019

Study Registration Dates

• First Submitted: November 25, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (ESTIMATE): December 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2020
• Last Update Submitted That Met QC Criteria: December 31, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neuromuscular Diseases; Polymyositis; Myositis; Dermatomyositis
• Other Study ID Numbers: IFN-K-005-DM; 2016-000137-52 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No