Phase IIa exploratory study to assess the safety and effect of IFNa-Kinoid (IFN-K) in adult patients with Dermatomyositis
- Conditions
- DermatomyositisMedDRA version: 19.1 Level: PT Classification code 10012503 Term: Dermatomyositis System Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-000137-52-DE
- Lead Sponsor
- eovacs SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
1. Has provided written informed consent
2. Patient newly diagnosed or relapsing with definite” or probable” dermatomyositis based on ENMC criteria (2004)
3. Patient with an MMT-8 =120 and/or an MMT-5 =22
4. Patient:
•requiring corticosteroids (CS) at a dose of 1 mg/Kg or = 70 mg of prednisone equivalent/day
•or currently receiving CS at a dose of 1 mg/Kg or = 70 mg of prednisone equivalent/day for less than 2 weeks at the time of screening visit
5. Must have a muscle biopsy if not performed within 1 month at the time of screening visit
6. Is a male or female, aged between 18 and 65 years, inclusive, at the time of the screening visit
7. Study patient and his/her partner has to use effective method of contraception for the duration of the study including the Extended Follow-up period
Note: If of child-bearing potential, effective contraception methods include:
i. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks prior to the first planned administration of the study product. In case of oophorectomy alone, the reproductive status of the woman must be confirmed by follow-up hormone level assessment.
ii. Male sterilization (at least 6 months prior to Screening).
iii. Combination of the following:
•Oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception
•Or Placement of an intrauterine device (IUD) or intrauterine system (IUS)
•AND Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps)
A combination of the use of condoms and the use of oil and grease containing chemical contraceptives (vaginal suppositories, tablets, gel) is not recommended, as the grease and oil might affect the condom and cause it to leak, and therefore reduces the contraception safety (pearl index not below 1%).
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago prior screening visit. In the case of oophorectomy alone, women are considered not of child bearing potential only when their reproductive status have been confirmed by follow-up hormone level assessment.
8. Is able and willing to comply with the requirements of the study protocol (e.g. completion of the diary cards, return for follow-up visits), in the opinion of the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Is high-risk human papilloma virus (HPV) positive by reverse transcription polymerase chain reaction (RT-qPCR) on a cervical swab at Screening or within 3 months prior to the first planned study product administration
2. Has cytological abnormalities = HSIL on a cervical swab at Screening or within 3 months prior to the first planned study product administration
3. Is positive for autoantibodies anti-NXP2, TIF1?, MDA5 or anti-synthetase antibodies
4. Is positive for any malignancy documented at the time of screening visit, i.e. by biological markers, images*, biopsies* or endoscopies*
*note: please refer to study flow chart for acceptable window period for previous exams
5. Has a history of any malignancy except than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix within five years prior to study entry
6. Has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
7. Has preexisting severe cardiac or pulmonary conditions
8. Has received IV pulse dose CS (= 250 mg prednisone equivalent/day) within 3 months prior to the first planned administration of the study product
9. Has received intravenous immunoglobulin (IVIg) within 4 months before the first administration of the study product
10. Has received potent immunosuppressive drugs such as cyclophosphamide, methotrexate, azathioprine, mycophenolate, cyclosporine A, oral tacrolimus within 12 months prior to the first planned administration of the study product
11. Has received abatacept, anifrolumab, belimumab, TNF antagonists or another registered or investigational biological therapy within 12 months prior to the first planned administration of the study product
12. Has received anti-B-cell therapy (e.g. rituximab, epratuzumab) within 12 months prior to the first planned administration of the study product
13. Has received any live vaccine within 3 months prior to the first planned administration of the study product (e.g. nasal flu vaccine, oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine)
14. Has used any investigational or non-registered product within 30 days or 5 half-lives, whichever is longer, or any investigational or non-registered vaccine within 30 days prior to the first planned administration of the study product
15. Has significant electrocardiogram (ECG) abnormalities other that consistent with dermatomyositis that are clinically relevant and preclude study eligibility in the investigator’s opinion
16. Has inflammatory joint or skin disease other than dermatomyositis that may interfere with study assessments
17. Has frequent recurrences of oral or genital herpes simplex lesions
(= 6 occurrences during the 12 months prior to first study product administration)
18. Has had an episode of shingles during the 12 months prior to
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method