NCT01058343

Safety of IFNa Kinoid in Systemic Lupus Erythematosus

A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Neovacs · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	IFN-K	3 to 4 IM injections over 3 months

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-04-01
• Completion: 2016-06-01
• First posted: 2010-01-28
• Last updated: 2019-03-21

Locations

15 sites across 6 countries: Belgium, Bulgaria, Croatia, France, Germany, Switzerland