A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus

Summary

The purpose of this study is to assess the safety and tolerability of JNJ-55920839 following single ascending intravenous (IV) dose administration in healthy participants and a single subcutaneous dose in healthy participants and multiple IV dose administrations in participants with mild to moderate Systemic Lupus Erythematosus (SLE).

Timeline

Start

2015-12

Primary completion

2018-09

Completion

2018-09

Publications

• Jordan J, Benson J, Chatham WW, Furie RA, Stohl W, Wei JC, Marciniak S, Yao Z, Srivastava B, Schreiter J, Cesaroni M, Orillion A, Seridi L, Chevrier M. First-in-Human study of JNJ-55920839 in healthy volunteers and patients with systemic lupus erythematosus: a randomised placebo-controlled phase 1 trial. Lancet Rheumatol. 2020 Oct;2(10):e613-e622. doi: 10.1016/S2665-9913(20)30223-X. Epub 2020 Aug 21.
• Yao Z, Loggia L, Fink D, Chevrier M, Marciniak S, Sharma A, Xu Z. Pharmacokinetics and Pharmacodynamics of JNJ-55920839, an Antibody Targeting Interferon alpha/omega, in Healthy Subjects and Subjects with Mild-to-Moderate Systemic Lupus Erythematosus. Clin Drug Investig. 2020 Dec;40(12):1127-1136. doi: 10.1007/s40261-020-00978-4. Epub 2020 Oct 21.

Drugs

Indications