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Study of IFN-K in Dermatomyositis

This study is currently recruiting participants.
Verified September 2017 by Neovacs
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980198
First Posted: December 2, 2016
Last Update Posted: September 11, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Neovacs
  Purpose
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 Intervention Phase
Dermatomyositis Biological: IFN-Kinoid Other: Placebo Other: ISA 51 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Neovacs:

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

Secondary Outcome Measures:
  • Number of subjects with treatment related adverse events [ Time Frame: Week 48 ]
  • 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 ]
  • Others tools: Cutaneous Disease Area and Severity Index (CDASI) [ Time Frame: Week 0, Week 12, Week 24, Week 36, Week 48 ]
  • Others tools: Manual Muscle Testing (MMT5) [ Time Frame: Week 0, Week 12, Week 24, Week 36, Week 48 ]
  • Others tools: Accelerometer [ Time Frame: Week 0, Week 12, Week 24, Week 36, Week 48 ]
  • Others tools:Dermatology Life Quality Index (DLQI score) [ Time Frame: Week 0, Week 12, Week 24, Week 36, Week 48 ]
  • Immune response induced by IFN-K as measured by antibodies production [ Time Frame: Week 48 ]

Estimated Enrollment: 30
Study Start Date: November 2016
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IFN-Kinoid
IFN-Kinoid + ISA 51
Biological: IFN-Kinoid Other: ISA 51
Placebo Comparator: Placebo
Placebo + ISA 51
Other: Placebo Other: ISA 51

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02980198


Contacts
Contact: Neovacs SA + 33 1 53 10 93 00 contact@neovacs.com

Locations
France
Research site Not yet recruiting
Lille, France, 59037
Research site Not yet recruiting
Marseille, France, 13354
Research site Not yet recruiting
Paris, France, 75010
Research site Recruiting
Paris, France, 75013
Research site Not yet recruiting
Strasbourg, France, 67098
Germany
Charité - Universitätsmedizin Berlin Rudolf- Virchow- Haus Not yet recruiting
Berlin, Germany, 10117
Italy
Research site Not yet recruiting
Padova, Italy, 35128
Switzerland
Research site Not yet recruiting
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Neovacs
  More Information

Responsible Party: Neovacs
ClinicalTrials.gov Identifier: NCT02980198     History of Changes
Other Study ID Numbers: IFN-K-005-DM
2016-000137-52 ( EudraCT Number )
First Submitted: November 25, 2016
First Posted: December 2, 2016
Last Update Posted: September 11, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases