Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: IFNα-Kinoid; Placebo; ISA 51 VG
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The safety and immunogenicity of the IFNα-Kinoid (IFN-K) have been evaluated in a phase I
      clinical study conducted in subjects with Systemic Lupus Erythematosus (SLE). Preliminary
      results showed acceptable safety profile and patients developped antibodies response.

      The principal aim of the present study is to confirm the neutralization of the interferon
      gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the
      immune responses and the safety elicited by IFN-K will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has had a diagnosis of SLE according to current American College of Rheumatology (ACR)
             criteria (4 of 11 ACR criteria)

          -  Has SLEDAI-2K ≥ 6

          -  Has at least 1 BILAG A and/or at least 2 BILAG B

          -  Has a positive IFN gene signature by reverse transcription quantitative polymerase
             chain reaction (RT-qPCR)

          -  Has anti-nuclear antibodies (ANA) ≥ 1:160 and/or anti-dsDNA antibodies ≥ 7.0 IU/mL

          -  Currently receiving at least one treatment for SLE

        Exclusion Criteria:

          -  Has active, severe lupus nephritis as defined either by the immediate need for
             cyclophosphamide treatment or by renal BILAG A

          -  Has active, severe, neuropsychiatric SLE, defined as neuropsychiatric BILAG A

          -  Has been treated with corticosteroids (CS) at a dose of >20 mg of prednisone
             equivalent/day for > 7 consecutive days

          -  Is currently receiving or has received pulse dose CS (≥ 250 mg prednisone
             equivalent/day)

          -  Has received potent immunosuppressive drugs

          -  Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, tumor
             necrosis factor (TNF) antagonists or another registered or investigational biological
             therapy

          -  Has received anti-B-cell therapy (e.g., rituximab, epratuzumab)

          -  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

          -  Has received any live vaccine

          -  Has used any investigational or non-registered product or any investigational or
             non-registered vaccine

          -  Is high-risk human papilloma virus (HPV) positive by rRT-qPCR on a cervical swab

          -  Has cytological abnormalities ≥ high grade squamous intraepithelial lesions (HSIL) on
             a cervical swab