DermatomyositisPhase 2NCT02980198
Study of IFN-K in Dermatomyositis
A Phase 2 study testing IFN-Kinoid and ISA 51 in people with Dermatomyositis, run by Neovacs at 8 sites in 4 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- IFN-Kinoid and ISA 51
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 3 May 2017to 11 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
France5 sites
Research site
Lille, 59037
Research site
Marseille, 13354
Research site
Paris, 75010
Research site
Paris, 75013
Research site
Strasbourg, 67098
Germany1 site
Charité - Universitätsmedizin Berlin Rudolf- Virchow- Haus
Berlin, 10117
About this study
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
This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα antibodies (immune response) in adult subjects with dermatomyositis
- Conditions
- Dermatomyositis
- Being tested
- IFN-Kinoid, Placebo, ISA 51
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFN-KinoidBiological
IM administration
PlaceboOther
IM administration
ISA 51Other
adjuvant
| Study group | Role | What they receive |
|---|---|---|
| IFN-Kinoid | Experimental | IFN-Kinoid + ISA 51 Receives: Biological: IFN-Kinoid; Other: ISA 51 |
| Placebo | Placebo comparator | Placebo + ISA 51 Receives: Other: Placebo; Other: ISA 51 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the expression of IFN-induced genes at Week 48
Measured: Week 48
Secondary outcomes (7)
Number of subjects with treatment related adverse events
Measured: Week 48
Total improvement score from IMAC Core Set Measures (CSM) following Aggarwal et al (2017) recommendations
Measured: Week 0, Week 12, Week 24, Week 36, Week 48
Others tools: Cutaneous Disease Area and Severity Index (CDASI)
Measured: Week 0, Week 12, Week 24, Week 36, Week 48
Others tools: Manual Muscle Testing (MMT5)
Measured: Week 0, Week 12, Week 24, Week 36, Week 48
Others tools: Accelerometer
Measured: Week 0, Week 12, Week 24, Week 36, Week 48
Others tools:Dermatology Life Quality Index (DLQI score)
Measured: Week 0, Week 12, Week 24, Week 36, Week 48
Immune response induced by IFN-K as measured by antibodies production
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start3 May 2017
- Primary completion11 Dec 2019
- Study completion11 Dec 2019
Why it stopped: reorganization proceedings with a potential risk of company liquidation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neovacs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980198
- Sponsor's protocol ID
- IFN-K-005-DM
- Other IDs
- 2016-000137-52, 2016
- Status last verified
- Dec 2019
- First submitted
- 25 Nov 2016
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02980198
- Acronym / sponsor ID
- IFN-K-005-DM
- Conditions
- Dermatomyositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: reorganization proceedings with a potential risk of company liquidation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NeovacsIndustry (pharma, biotech, devices)
- Study start
- 3 May 2017 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα antibodies (immune response) in adult subjects with dermatomyositis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IFN-Kinoid | Experimental | Biological: IFN-Kinoid, Other: ISA 51IFN-Kinoid + ISA 51 |
| Placebo | Placebo comparator | Other: Placebo, Other: ISA 51Placebo + ISA 51 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IFN-KinoidIM administration | Biological | IFN-Kinoid |
| PlaceboIM administration | Other | Placebo |
| ISA 51adjuvant | Other | IFN-Kinoid, Placebo |
Primary outcome
Change from baseline in the expression of IFN-induced genes at Week 48
Time frame: Week 48
7 secondary outcomes
Number of subjects with treatment related adverse events
Time frame: Week 48
Total improvement score from IMAC Core Set Measures (CSM) following Aggarwal et al (2017) recommendations
Time frame: Week 0, Week 12, Week 24, Week 36, Week 48
Others tools: Cutaneous Disease Area and Severity Index (CDASI)
Time frame: Week 0, Week 12, Week 24, Week 36, Week 48
Others tools: Manual Muscle Testing (MMT5)
Time frame: Week 0, Week 12, Week 24, Week 36, Week 48
Others tools: Accelerometer
Time frame: Week 0, Week 12, Week 24, Week 36, Week 48
Others tools:Dermatology Life Quality Index (DLQI score)
Time frame: Week 0, Week 12, Week 24, Week 36, Week 48
Immune response induced by IFN-K as measured by antibodies production
Time frame: Week 48
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IFN-Kinoid and ISA 51 in people with Dermatomyositis, run by Neovacs at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Germany, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the expression of IFN-induced genes at Week 48 (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.