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Trial record 7 of 7 for:    neovacs

Study of IFN-K in Dermatomyositis

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Neovacs
Sponsor:
Information provided by (Responsible Party):
Neovacs
ClinicalTrials.gov Identifier:
NCT02980198
First received: November 25, 2016
Last updated: November 29, 2016
Last verified: November 2016
  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 Blind (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 ]
  • Response to treatment with IFN-K as measured by MMT5/MMT8 [ Time Frame: Week 48 ]
  • Response to treatment with IFN-K as measured by CDASI [ Time Frame: Week 48 ]
  • Response to treatment with IFN-K as measured by Physician global activity (PGA) [ Time Frame: Week 48 ]
  • Response to treatment with IFN-K as measured by Patient Global Activity [ Time Frame: Week 48 ]
  • Response to treatment with IFN-K as measured by Health Assessment Questionnaire (HAQ),Dermatology Life Quality Index (DLQI) [ Time Frame: 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

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 with an MMT-8 ≤ 120 and/or an MMT-5 ≤ 22
  • Patient requiring corticosteroids (CS) at a dose of 1 mg/Kg or ≤ 70 mg of prednisone equivalent/day or currently receiving CS at a dose of 1 mg/Kg or ≤ 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

Exclusion Criteria:

  • Is high-risk human papilloma virus (HPV) positive by (RT-qPCR) on a cervical swab
  • Has cytological abnormalities ≥ HSIL on a cervical swab
  • Is positive for autoantibodies anti-NXP2, TIF1ɤ, MDA5 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02980198

Locations
France
Hôpital Claude Huriez, CHRU de Lille Not yet recruiting
Lille, France, 59037
Contact: Eric Hachulla, MD, PhD         
Principal Investigator: Eric Hachulla, MD, PhD         
Assistance Publique - Hôpitaux de Marseille Not yet recruiting
Marseille, France, 13354
Contact: Nicolas Schleinitz, MD, PhD         
Principal Investigator: Nicolas Schleinitz, MD, PhD         
Hôpital Saint-Louis Not yet recruiting
Paris, France, 75010
Contact: Jean-David Bouaziz, MD, PhD         
Principal Investigator: Jean-David Bouaziz, MD, PhD         
Hôpital Pitié-Salpêtrière, AP-HP Not yet recruiting
Paris, France, 75013
Contact: Olivier Benveniste, MD, PhD         
Principal Investigator: Olivier Benveniste, MD, PhD         
CHRU Strasbourg-Hôpital Hautepierre Not yet recruiting
Strasbourg, France, 67098
Contact: Jean Sibilia, MD, PhD         
Principal Investigator: Jean Sibilia, MD, PhD         
Germany
Charité - Universitätsmedizin Berlin Rudolf- Virchow- Haus Not yet recruiting
Berlin, Germany, 10117
Contact: Eugen Feist, MD, PhD       Eugen.Feist@charite.de   
Principal Investigator: Eugen Feist, MD, PhD         
Italy
Università degli Studi di Padova Not yet recruiting
Padova, Italy, 35128
Contact: Andrea Doria, MD, PhD         
Principal Investigator: Andrea Doria, MD, PhD         
Switzerland
Centre Hopsitalier Universitaires Vaudois Recruiting
Lausanne, Switzerland, 1011
Contact: François Spertini, MD, PhD       francois.spertini@chuv.ch   
Principal Investigator: François Spertini, MD, PhD         
United Kingdom
Aintree University Hospital Not yet recruiting
Liverpool, United Kingdom, L9 7AL
Contact: Robert Cooper, MD, PhD         
Principal Investigator: Robert Cooper, MD, PhD         
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 )
Study First Received: November 25, 2016
Last Updated: November 29, 2016

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

ClinicalTrials.gov processed this record on July 21, 2017