A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus
Phase of Trial: Phase III
Latest Information Update: 30 Jan 2019
At a glance
- Drugs Ustekinumab (Primary) ; Ustekinumab (Primary)
- Indications Systemic lupus erythematosus
- Focus Registrational; Therapeutic Use
- Acronyms LOTUS
- Sponsors Janssen Pharmaceutical KK; Janssen Research & Development; Janssen-Cilag
- 23 Oct 2018 Janssen will collaborate with the Lupus Foundation of America (LFA) to incorporate the Rapid Evaluation of Activity in Lupus (LFA-REAL™) instrument into the study.
- 03 Oct 2018 Planned primary completion date changed from 21 Jan 2021 to 22 Jan 2021.
- 08 Aug 2018 Planned End Date changed from 30 Jun 2023 to 31 Aug 2028.