Trials / Terminated
TerminatedNCT02665364
Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 185 (actual)
- Sponsor
- Neovacs · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IFNα-Kinoid | |
| OTHER | Placebo | |
| OTHER | ISA 51 VG |
Timeline
- Start date
- 2015-09-23
- Primary completion
- 2018-03-15
- Completion
- 2020-02-04
- First posted
- 2016-01-27
- Last updated
- 2020-04-09
- Results posted
- 2020-03-26
Locations
101 sites across 21 countries: United States, Argentina, Belgium, Chile, Colombia, Croatia, France, Georgia, Germany, Italy, Mexico, Moldova, Peru, Philippines, Poland, Russia, South Korea, Switzerland, Taiwan, Thailand, Tunisia
Source: ClinicalTrials.gov record NCT02665364. Inclusion in this directory is not an endorsement.