Study of IFN-K in Dermatomyositis

Dermatomyositis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02980198
• Other study ID #: IFN-K-005-DM
• Secondary ID: 2016-000137-52
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 3, 2017
• Est. completion date: December 11, 2019

Study information

• Verified date: December 2019
• Source: Neovacs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 11, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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, TIF1?, 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

Related Conditions & MeSH terms

• Dermatomyositis

Intervention

Biological:
• IFN-Kinoid
IM administration

Other:
• Placebo
IM administration
• ISA 51
adjuvant

Locations

Country	Name	City	State
France	Research site	Lille
France	Research site	Marseille
France	Research site	Paris
France	Research site	Paris
France	Research site	Strasbourg
Germany	Charité - Universitätsmedizin Berlin Rudolf- Virchow- Haus	Berlin
Italy	Research site	Padova
Switzerland	Research site	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Neovacs

Countries where clinical trial is conducted

France,  Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the expression of IFN-induced genes at Week 48		Week 48
Secondary	Number of subjects with treatment related adverse events		Week 48
Secondary	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
Secondary	Others tools: Cutaneous Disease Area and Severity Index (CDASI)		Week 0, Week 12, Week 24, Week 36, Week 48
Secondary	Others tools: Manual Muscle Testing (MMT5)		Week 0, Week 12, Week 24, Week 36, Week 48
Secondary	Others tools: Accelerometer		Week 0, Week 12, Week 24, Week 36, Week 48
Secondary	Others tools:Dermatology Life Quality Index (DLQI score)		Week 0, Week 12, Week 24, Week 36, Week 48
Secondary	Immune response induced by IFN-K as measured by antibodies production		Week 48