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Phase IIb Study of IFN-K in Systemic Lupus Erythematosus

NCT02665364 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2020-04-09

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

IFNα-Kinoid

OTHER

Placebo

OTHER

ISA 51 VG

Sponsors & Collaborators

  • Neovacs

    lead INDUSTRY

Principal Investigators

  • Frédéric Houssiau, MD, PhD · Head of Rhumatology, UCL, Brussels, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-23
Primary Completion
2018-03-15
Completion
2020-02-04

Countries

  • United States
  • Argentina
  • Belgium
  • Chile
  • Colombia
  • Croatia
  • France
  • Georgia
  • Germany
  • Italy
  • Mexico
  • Moldova
  • Peru
  • Philippines
  • Poland
  • Russia
  • South Korea
  • Switzerland
  • Taiwan
  • Thailand
  • Tunisia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02665364 on ClinicalTrials.gov