Study of IFN-K in Dermatomyositis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-03

Study Completion Date

2019-12-11

Brief Summary

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

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Detailed Description

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Conditions

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Dermatomyositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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IFN-Kinoid

IFN-Kinoid + ISA 51

Group Type EXPERIMENTAL

IFN-Kinoid

Intervention Type BIOLOGICAL

IM administration

ISA 51

Intervention Type OTHER

adjuvant

Placebo

Placebo + ISA 51

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

IM administration

ISA 51

Intervention Type OTHER

adjuvant

Interventions

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IFN-Kinoid

IM administration

Intervention Type BIOLOGICAL

Placebo

IM administration

Intervention Type OTHER

ISA 51

adjuvant

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No