Study of IFN-K in Systemic Lupus Erythematosus

Inclusion Criteria:

- Has had a diagnosis of SLE according to current 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 RT-qPCR

- Has 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, 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 ≥ HSIL on a cervical swab