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Study of IFN-K in Dermatomyositis

Primary Purpose

Dermatomyositis

Status

Withdrawn

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

IFN-Kinoid

Placebo

ISA 51

About this trial

This is an interventional treatment trial for Dermatomyositis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IFN-Kinoid

Placebo

Arm Description

IFN-Kinoid + ISA 51

Placebo + ISA 51

Outcomes

Primary Outcome Measures

Change from baseline in the expression of IFN-induced genes at Week 48

Secondary Outcome Measures

Number of subjects with treatment related adverse events

Total improvement score from IMAC Core Set Measures (CSM) following Aggarwal et al (2017) recommendations

Others tools: Cutaneous Disease Area and Severity Index (CDASI)

Others tools: Manual Muscle Testing (MMT5)

Others tools: Accelerometer

Others tools:Dermatology Life Quality Index (DLQI score)

Immune response induced by IFN-K as measured by antibodies production

Full Information

NCT ID

NCT02980198

First Posted

November 25, 2016

Last Updated

December 31, 2019

Sponsor

Neovacs

1. Study Identification

Unique Protocol Identification Number

NCT02980198

Brief Title

Study of IFN-K in Dermatomyositis

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Withdrawn

Why Stopped

reorganization proceedings with a potential risk of company liquidation

Study Start Date

May 3, 2017 (Actual)

Primary Completion Date

December 11, 2019 (Actual)

Study Completion Date

December 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neovacs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatomyositis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IFN-Kinoid

Arm Type

Experimental

Arm Description

IFN-Kinoid + ISA 51

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo + ISA 51

Intervention Type

Biological

Intervention Name(s)

IFN-Kinoid

Intervention Description

IM administration

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

IM administration

Intervention Type

Other

Intervention Name(s)

ISA 51

Intervention Description

adjuvant

Primary Outcome Measure Information:

Title

Change from baseline in the expression of IFN-induced genes at Week 48

Time Frame

Week 48

Secondary Outcome Measure Information:

Title

Number of subjects with treatment related adverse events

Time Frame

Week 48

Title

Total improvement score from IMAC Core Set Measures (CSM) following Aggarwal et al (2017) recommendations

Time Frame