Phase IIb study of IFN-K in Systemic Lupus Erythematosus

Phase 1

Conditions: Systemic Lupus Erythematosus
MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2015-001341-86-IT

Lead Sponsor: EOVACS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 185

Inclusion Criteria

1. Has had a diagnosis of SLE according to current ACR criteria (4 of 11 ACR criteria)
2. Has SLEDAI-2K = 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 and be on stable dose (= 20 mg/week) for at least 12 weeks prior to the first planned administration of the study product
• Azathioprine (AZA); the patient must have been treated and be on a stable dose (= 2.5 mg/kg/day) for at least 12 weeks prior to the first planned administration of the study product
• Mycophenolate mofetil (MMF), the patient must have been treated and be on stable dose (= 2 g/day) for at least 12 weeks prior to the first planned administration of the study product
9. 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:
- 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 follow-up visits),
in the opinion of the Investigator
11. Has provided written informed consent
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 178
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subje

Exclusion Criteria

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 administration of the study product, has been treated with corticosteroids (CS) at a dose of>20mg 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 6months prior to the first planned administration of the study product
7.Has received anti-B-cell therapy (e.g., rituximab, epratuzumab) within 12months prior to the first planned administration of the study product
8.Has significant 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 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 12months prior to first study product administration)
13.Has had an episode of shingles during the 12months prior to the first planned administration of the study product
14.Has no IgG against herpes simplex virus (HSV-1 and HSV-2), VZV, CMV or EBV
15.Is positive for HTLV 1-2 antibodies, HIV antibodies, HCV antibodies, or 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, 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 nonregistered vaccine within 30 days prior to the first planned administration of the study product
19.Has a history of chronic alcohol and/or drug 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 period
21.Has known hypersensitivity to any component of the study product
22.Is high-risk HPV positive by RT-qPCR on a cervical swab at Screening or within 3 months prior to the first planned study product administration
23.Has cytological abnormalities = HSIL on a cervical swab at Screening or within 3 months prior to the first planned study product administration

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

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