NCT02980198

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2017

Geographic Reach
4 countries

8 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

May 3, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2019

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

2.6 years

First QC Date

November 25, 2016

Last Update Submit

December 31, 2019

Conditions

Dermatomyositis

Outcome Measures

Primary Outcomes (1)

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

    Week 48

Secondary Outcomes (7)

  • Number of subjects with treatment related adverse events

    Week 48

  • 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

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

    Week 0, Week 12, Week 24, Week 36, Week 48

  • Others tools: Manual Muscle Testing (MMT5)

    Week 0, Week 12, Week 24, Week 36, Week 48

  • Others tools: Accelerometer

    Week 0, Week 12, Week 24, Week 36, Week 48

  • +2 more secondary outcomes

Study Arms (2)

IFN-Kinoid

EXPERIMENTAL

IFN-Kinoid + ISA 51

Biological: IFN-KinoidOther: ISA 51

Placebo

PLACEBO COMPARATOR

Placebo + ISA 51

Other: PlaceboOther: ISA 51

Interventions

IFN-KinoidBIOLOGICAL

IM administration

IFN-Kinoid
PlaceboOTHER

IM administration

Placebo
ISA 51OTHER

adjuvant

IFN-KinoidPlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research site

Lille, 59037, France

Location

Research site

Marseille, 13354, France

Location

Research site

Paris, 75010, France

Location

Research site

Paris, 75013, France

Location

Research site

Strasbourg, 67098, France

Location

Charité - Universitätsmedizin Berlin Rudolf- Virchow- Haus

Berlin, 10117, Germany

Location

Research site

Padua, 35128, Italy

Location

Research site

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Dermatomyositis

Interventions

montanide ISA 51

Condition Hierarchy (Ancestors)

PolymyositisMyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2016

First Posted

December 2, 2016

Study Start

May 3, 2017

Primary Completion

December 11, 2019

Study Completion

December 11, 2019

Last Updated

January 3, 2020

Record last verified: 2019-12

Locations

DE(1)IT(1)FR(5)CH(1)