Antiferon (interferon alpha kinoid) - Neovacs
(-) Safety of IFNa kinoid in systemic lupus erythematosus (clinicaltrials.gov) - Jul 2, 2012 - P1/2, N=28; Active, not recruiting; Completion date: Dec 2011 -> Aug 2013 
Trial completion date • Immunology • Lupus
http://clinicaltrials.gov/ct2/show/NCT01058343
 
Jul 2, 2012
 
This study is ongoing, but not recruiting participants. First Received on January 27, 2010.   Last Updated on July 2, 2012   History of Changes Sponsor: Neovacs Information provided by (Responsible Party): Neovacs ClinicalTrials.gov Identifier: NCT01058343 Purpose 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. Condition  Systemic Lupus Erythematosus Intervention  Biological: IFN-K Phase Phase 1 Phase 2 Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment Official Title: A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus. Resource links provided by NLM: MedlinePlus related topics: Lupus U.S. FDA Resources  Further study details as provided by Neovacs: Primary Outcome Measures: Frequency and severity of adverse events [ Time Frame: study duration ] [ Designated as safety issue: Yes ] Secondary Outcome Measures: Proportion of patients with anti IFNa antibodies [ Time Frame: Month 4 ] [ Designated as safety issue: No ] Enrollment: 28 Study Start Date: March 2010 Estimated Study Completion Date: August 2013 Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)