Phase IIb Study of IFN-K in Systemic Lupus Erythematosus

Neovacs

Status and phase: Terminated; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Other: Placebo; Biological: IFNα-Kinoid; Other: ISA 51 VG

Study type: Interventional

Funder types: Industry

Identifiers

NCT02665364

IFN-K-002

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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185 participants in 2 patient groups, including a placebo group

IFNα-Kinoid

Experimental group

Description:

IFNα-Kinoid (IFN-K) adjuvanted with ISA 51 VG via intramuscular injection. 1 administration of 240 μg at W0, W1, W4 and 1 administration of 120 μg at month 3 (W12) and month 6 (W24) in addition to standard of care treatment.

Treatment:

Biological: IFNα-Kinoid

Other: ISA 51 VG

Placebo

Placebo Comparator group

Description:

Placebo normal saline (0.9% Sodium Chloride) adjuvanted with ISA 51 VG via intramuscular injection. 1 administration of 240 μg at week (W)0, W1, W4 and 1 administration of 120 μg at month 3 (W12) and month 6 (W24) in addition to standard of care treatment.

Treatment:

Other: Placebo

Other: ISA 51 VG