A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus

TerminadoFase 2ClinicalTrials.gov

ID: NCT02665364Tipo: INTERVENTIONALInicio: 23 de sept de 2015Fin estimado: 4 de feb de 2020

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

biological

IFNα-Kinoid

other

Placebo

other

ISA 51 VG

Ubicaciones

Research Site

Buenos Aires, Argentina

Patrocinadores

PrincipalNeovacs

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