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Safety of IFNa Kinoid in Systemic Lupus Erythematosus

NCT01058343 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-03-21

No results posted yet for this study

Summary

Interferon alpha (IFNa) is involved in the pathogenesis of systemic lupus erythematosus (SLE)and IFNa levels are associated with the severity of the disease. Blocking IFNa could be an attractive therapeutic strategy. Active immunization with IFNa kinoid (IFN-K) induces a polyclonal antibody response.

This study will evaluate the safety of IFN-K in patients with mild to moderate SLE. It will also measure the induction of anti-IFNa antibodies and evaluate the clinical impact on SLE disease.

Conditions

Interventions

BIOLOGICAL

IFN-K

3 to 4 IM injections over 3 months

Sponsors & Collaborators

  • Neovacs

    lead INDUSTRY

Principal Investigators

  • Christian Jorgensen, MD, PhD · Unité Clinique d'Immuno-Rhumatologie Thérapeutique, Hôpital Lapeyronie, Montpellier, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-04-30
Completion
2016-06-30

Countries

  • Belgium
  • Bulgaria
  • Croatia
  • France
  • Germany
  • Switzerland

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 NCT01058343 on ClinicalTrials.gov