A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus
Latest Information Update: 05 Jan 2024
At a glance
- Drugs Ustekinumab (Primary) ; Ustekinumab (Primary)
- Indications Systemic lupus erythematosus
- Focus Registrational; Therapeutic Use
- Acronyms LOTUS
- Sponsors Janssen Research & Development; Janssen-Cilag
- 07 Jul 2022 Primary endpoint (Percentage of Participants Achieving an Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52) has not been met, according to Results published in the Annals of the Rheumatic Diseases.
- 07 Jul 2022 Results assessing efficacy and safety of ustekinumab in patients with active systemic lupus erythematosus, published in the Annals of the Rheumatic Diseases.
- 09 Mar 2021 Status changed from completed to discontinued as a result of the outcome of the pre-planned Interim Analysis.