Gender: Both
Maximum age: 65
Minimum age: 18
Inclusion criteria:
A patient meeting all of the following inclusion criteria at screening will be eligible for participation in this study:
1.Has had a diagnosis of SLE according to current ACR criteria (4 of 11 ACR criteria) (list of criteria provided in Appendix 1)
2.Has SLEDAI ≥ 6
3.Has at least 1 BILAG A and/or at least 2 BILAG B
4.Has a positive IFN gene signature by RT-qPCR as assessed on a limited number of genes
5.Has anti-nuclear antibodies (ANA) ≥ 1:160 and/or anti-dsDNA antibodies ≥ 7.0 IU/mL
6.Be a male or female, aged between 18 and 65 years, inclusive, at the time of the screening visit
7.Agrees to receive influenza vaccination during each influenza season of the study period
8.Currently receiving at least one of the following treatment:
?Corticosteroids (CS) at a dose of ≤ 20 mg of prednisone equivalent/day
?Antimalarial drugs (hydroxychloroquine [HCQ] or chloroquine [CQ]); the patient must have been treated since at least 8 weeks and on stable dose for at least 4 weeks prior to first planned administration of the study product
?Methotrexate (MTX); the patient must have been treated since at least 8 weeks and on stable dose (≤ 20 mg/week) for at least 4 weeks prior to the first planned administration of the study product
?Azathioprine (AZA); the patient must have been treated since at least 8 weeks and on stable dose (≤ 2.5 mg/kg/day) for at least 4 weeks prior to the first planned administration of the study product
?Mycophenolate mofetil (MMF), the patient must have been treated since at least 8 weeks and on stable dose (≤ 2 g/day) for at least 4 weeks prior to the first planned administration of the study product
9Study patient and his/her partner has to use effective method of contraception for the duration of the study plus 6 months.
Note: If of child bearing potential, effective contraception methods include:
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.Male sterilization (at least 6 months prior to Screening). 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)
?Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
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. In the case of oophorectomy alone, she is considered not of child bearing potential only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
10.Is able and willing to comply with the requirements of the study protocol (e.g., completion of the diary cards, return for fol
Exclusion criteria:
A patient meeting any of the following exclusion criteria at study entry will not be eligible for the study:
1.Has active, severe lupus nephritis as defined either by the immediate need for cyclophosphamide treatment or by renal BILAG A
2.Has active, severe, neuropsychiatric SLE, defined as neuropsychiatric BILAG A
3.During the 4 months prior to the first planned study product administration, has been treated with corticosteroids (CS) at a dose of >20 mg of prednisone equivalent/day for > 7 consecutive days
4.Is currently receiving or has received pulse dose CS (≥ 250 mg prednisone equivalent/day) within 3 months prior to the first planned administration of the study product.
5.Has received potent immunosuppressive drugs such as cyclophosphamide, cyclosporine A, oral tacrolimus within 3 months prior to the first planned administration of the study product
6.Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, TNF antagonists or another registered or investigational biological therapy within 6 months prior to the first planned administration of the study product
7.Has received anti-B-cell therapy (e.g., rituximab, epratuzumab) within 12 months prior to the first planned administration of the study product
8.Has significant electrocardiogram (ECG) abnormalities that are clinically relevant and preclude study eligibility in the Investigator?s opinion
9.Has inflammatory joint or skin disease other than SLE that may interfere with study assessments
10.Has any laboratory abnormality other than SLE related that is clinically relevant and precludes study entry in the Investigator?s opinion.
11.Has a history of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
12.Has frequent recurrences of oral or genital herpes simplex lesions (≥ 6 occurrences during the 12 months prior to first study product administration)
13.Has had an episode of shingles during the 12 months prior to the first planned administration of the study product
14.Has no IgG against herpes simplex virus (HSV-1 and HSV-2), varicella zoster virus (VZV), cytomegalovirus (CMV) or Epstein-Barr virus (EBV)
15.Is positive for HTLV 1-2 antibodies, HIV antibodies, Hepatitis C (HCV) antibodies, or Hepatitis B surface antigen (HBsAg)
16.Is at high risk of significant infection and/or has any current signs or symptoms of infection at entry or has received intravenous antibiotics within 2 months prior to the first planned administration of the study product
17.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-Guerin [BCG] vaccine, oral typhoid vaccine)
18.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
19.Has a history of chronic alcohol and/or product abuse within 6 months prior to the first planned administration of the study product
20.Is breastfeeding, pregnant, or planning to become pregnant during the study peri
