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Study of IFN-K in Dermatomyositis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02980198
Recruitment Status : Withdrawn (reorganization proceedings with a potential risk of company liquidation)
First Posted : December 2, 2016
Last Update Posted : January 3, 2020
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Dermatomyositis Biological: IFN-Kinoid Other: Placebo Other: ISA 51 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : May 3, 2017
Actual Primary Completion Date : December 11, 2019
Actual Study Completion Date : December 11, 2019

Arm Intervention/treatment
Experimental: IFN-Kinoid
IFN-Kinoid + ISA 51
Biological: IFN-Kinoid
IM administration

Other: ISA 51

Placebo Comparator: Placebo
Placebo + ISA 51
Other: Placebo
IM administration

Other: ISA 51

Primary Outcome Measures :
  1. Change from baseline in the expression of IFN-induced genes at Week 48 [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Number of subjects with treatment related adverse events [ Time Frame: Week 48 ]
  2. Total improvement score from IMAC Core Set Measures (CSM) following Aggarwal et al (2017) recommendations [ Time Frame: Week 0, Week 12, Week 24, Week 36, Week 48 ]
  3. Others tools: Cutaneous Disease Area and Severity Index (CDASI) [ Time Frame: Week 0, Week 12, Week 24, Week 36, Week 48 ]
  4. Others tools: Manual Muscle Testing (MMT5) [ Time Frame: Week 0, Week 12, Week 24, Week 36, Week 48 ]
  5. Others tools: Accelerometer [ Time Frame: Week 0, Week 12, Week 24, Week 36, Week 48 ]
  6. Others tools:Dermatology Life Quality Index (DLQI score) [ Time Frame: Week 0, Week 12, Week 24, Week 36, Week 48 ]
  7. Immune response induced by IFN-K as measured by antibodies production [ Time Frame: Week 48 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02980198

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Research site
Lille, France, 59037
Research site
Marseille, France, 13354
Research site
Paris, France, 75010
Research site
Paris, France, 75013
Research site
Strasbourg, France, 67098
Charité - Universitätsmedizin Berlin Rudolf- Virchow- Haus
Berlin, Germany, 10117
Research site
Padova, Italy, 35128
Research site
Lausanne, Switzerland, 1011
Sponsors and Collaborators
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Responsible Party: Neovacs Identifier: NCT02980198    
Other Study ID Numbers: IFN-K-005-DM
2016-000137-52 ( EudraCT Number )
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases