Phase IIb Study of IFN-K in Systemic Lupus Erythematosus

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT02665364

Run by

Neovacs

People needed

185

Starts

2015-09-23

Expected to finish

2020-02-04

Last updated by the study team

2020-04-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — La Jolla, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Fort Lauderdale, Florida, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Austin, Texas, United States
• Research Site — Buenos Aires, Argentina
• Research Site — Brussels, Belgium
• Research Site — Santiago, Chile
• Research Site — Santiago, Chile
• Research Site — Santiago, Chile
• Research Site — Santiago, Chile
• Research Site — Santiago, Chile
• Research Site — Medellín, Antioquia, Colombia
• Research Site — Barranquilla, Colombia
• Research Site — Bogotá, Colombia
• Research Site — Bogotá, Colombia
• Research Site — Bucaramanga, Colombia
• Research Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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