A Phase II Study of M2951 in SLE

Summary

M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).

Timeline

Start

2017-01-04

Primary completion

2019-11-27

Completion

2020-03-23

Outcome

Missed primary endpoint

Stopped: “Study is completed; primary analysis completed.”

registry DBPC Period: Placebo vs DBPC Period: M2951 25 mg QD; p = 0.5462 NCT02975336 ↗

registry DBPC Period: Placebo vs DBPC Period: M2951 75 mg QD; p = 0.5462 NCT02975336 ↗

registry DBPC Period: Placebo vs DBPC Period: M2951 50 mg BID; p = 0.5462 NCT02975336 ↗

Publications

• Montalban X, Wallace D, Genovese MC, Tomic D, Parsons-Rich D, Bolay CL, Kao AH, Guehring H. A plain language summary of what clinical studies can tell us about the safety of evobrutinib - a potential treatment for multiple sclerosis. Neurodegener Dis Manag. 2023 Aug;13(4):207-213. doi: 10.2217/nmt-2023-0003. Epub 2023 Jun 22.
• Montalban X, Wallace D, Genovese MC, Tomic D, Parsons-Rich D, Le Bolay C, Kao AH, Guehring H. Characterisation of the safety profile of evobrutinib in over 1000 patients from phase II clinical trials in multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus: an integrated safety analysis. J Neurol Neurosurg Psychiatry. 2023 Jan;94(1):1-9. doi: 10.1136/jnnp-2022-328799. Epub 2022 Nov 23.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evobrutinib	Small molecule	25 mg	Oral
Subject	Evobrutinib	Small molecule	50 mg	Oral
Subject	Evobrutinib	Small molecule	75 mg	Oral

Indications