Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis

Summary

The purpose of this study was to determine the efficacy, dose response, and safety of M52951 in participants with Rheumatoid Arthritis (RA), and to consider a dose to took forward into Phase III development.

Timeline

Start

2017-09-18

Primary completion

2019-09-23

Completion

2019-09-23

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs M2951 25 mg QD; p = 0.1746; Odds Ratio (OR) 1.48 (95% CI 0.84 to 2.61); Regression, Logistic NCT03233230 ↗

registry analysis (superiority test); Placebo vs M2951 75 mg QD; p = 0.8283; Odds Ratio (OR) 1.06 (95% CI 0.61 to 1.87); Regression, Logistic NCT03233230 ↗

registry analysis (superiority test); Placebo vs M2951 50 mg BID; p = 0.1298; Odds Ratio (OR) 1.55 (95% CI 0.88 to 2.74); Regression, Logistic NCT03233230 ↗

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.

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