Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
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.
Timeline
- Start
- 2015-09-23
- Primary completion
- 2018-03-15
- Completion
- 2020-02-04
Outcome
Mixed primary results
Stopped: “Reorganization proceedings of the sponsor”
paper IFN-K induced neutralising anti-IFN-α2b serum antibodies in 91% of treated patients and reduced the IFN gene signature (p<0.0001). PMID 31871140 ↗
paper Modified BICLA responses at W36 did not statistically differ between IFN-K (41%) and PBO (34%). PMID 31871140 ↗
paper Although the clinical coprimary endpoint was not met, relevant secondary endpoints were achieved in the IFN-K group PMID 31871140 ↗
Publications
- Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
- Houssiau FA, Thanou A, Mazur M, Ramiterre E, Gomez Mora DA, Misterska-Skora M, Perich-Campos RA, Smakotina SA, Cerpa Cruz S, Louzir B, Croughs T, Tee ML. IFN-alpha kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study. Ann Rheum Dis. 2020 Mar;79(3):347-355. doi: 10.1136/annrheumdis-2019-216379. Epub 2019 Dec 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IFNα-Kinoid | Vaccine | 120 ug | Intramuscular |