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Evobrutinib

DRUG10 trials

Sponsors

EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Conditions

HealthyRelapsing Multiple SclerosisRelapsing-remitting Multiple SclerosisRenal Impairment

Phase 1

Effect of Renal Impairment on Evobrutinib Pharmacokinetics (PK)
CompletedNCT03436394
Merck KGaA, Darmstadt, GermanyRenal Impairment
Start: 2018-03-21End: 2019-02-22Updated: 2019-05-16
Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib
CompletedNCT03725072
Merck KGaA, Darmstadt, GermanyHealthy
Start: 2018-10-30End: 2018-12-05Updated: 2020-07-07
Effect of Meal Composition and Timing on Evobrutinib Bioavailability
CompletedNCT03934502
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyHealthy
Start: 2019-04-15End: 2019-06-12Updated: 2020-07-07
Relative Bioavailability (rBA) of Evobrutinib Intended Commercial and Clinical Tablets, and Effect of Food on Intended Commercial Tablets
CompletedNCT04314024
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyHealthy
Start: 2020-05-25End: 2020-06-23Updated: 2020-07-10
DDI Study of Evobrutinib and Carbamazepine
CompletedNCT05248945
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyHealthy
Start: 2022-01-13End: 2022-07-18Updated: 2026-01-15

Phase 2

A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis
TerminatedNCT02975349
EMD Serono Research & Development Institute, Inc.Relapsing-remitting Multiple Sclerosis
Start: 2017-03-07End: 2024-04-02Updated: 2025-05-14

Phase 3

Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)
TerminatedNCT04032158
EMD Serono Research & Development Institute, Inc.Relapsing-remitting Multiple Sclerosis
Start: 2019-08-26End: 2020-04-16Updated: 2021-08-05
Study of Evobrutinib in Participants With RMS
TerminatedNCT04032171
EMD Serono Research & Development Institute, Inc.Relapsing-remitting Multiple Sclerosis
Start: 2019-09-10End: 2020-05-20Updated: 2021-08-05
Study of Evobrutinib in Participants With RMS (evolutionRMS 2)
TerminatedNCT04338061
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyRelapsing Multiple Sclerosis
Start: 2020-07-02End: 2024-03-19Updated: 2025-03-21
Study of Evobrutinib in Participants With RMS (evolutionRMS 1)
TerminatedNCT04338022
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyRelapsing Multiple Sclerosis
Start: 2020-06-12End: 2024-03-08Updated: 2025-06-12

Related Papers

Safety and efficacy of evobrutinib in relapsing multiple sclerosis (evolutionRMS1 and evolutionRMS2): two multicentre, randomised, double-blind, active-controlled, phase 3 trials.
2024-09-1938 citations
Effect of Evobrutinib on Slowly Expanding Lesion Volume in Relapsing Multiple Sclerosis: A Post Hoc Analysis of a Phase 2 Trial.
2024-02-0915 citations
Antibody response to SARS-CoV-2 vaccines in patients with relapsing multiple sclerosis treated with evobrutinib: A Bruton’s tyrosine kinase inhibitor
Multiple Sclerosis Journal2023-08-254 citations
A Plain Language Summary of What Clinical Studies Can Tell Us About the Safety of Evobrutinib – a Potential Treatment for Multiple Sclerosis
Neurodegenerative Disease Management2023-06-223 citations
Efficacy and Safety of the Bruton’s Tyrosine Kinase Inhibitor Evobrutinib for Relapsing Multiple Sclerosis Over 3.5 Years of Treatment: An Ongoing Phase II Open-Label Extension (S16.008)
Neurology2023-04-253 citations
Neurofilament Light Chain Levels and Disease Activity During Long-Term Treatment of Relapsing Multiple Sclerosis with the Bruton’s Tyrosine Kinase Inhibitor Evobrutinib (P1-3.011)
Neurology2023-04-252 citations
Immune Response Following COVID-19 Vaccination (mRNA or Non-mRNA) in Patients with Relapsing Multiple Sclerosis Treated with the Bruton’s Tyrosine Kinase Inhibitor Evobrutinib: An Update (P2-3.017)
Neurology2023-04-25
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
Journal of Neurology Neurosurgery & Psychiatry2022-11-2329 citations
Determination of a clinically effective evobrutinib dose: Exposure–response analyses of a phase<scp>II</scp>relapsing multiple sclerosis study
Clinical and Translational Science2022-09-2014 citations
Evobrutinib, a covalent Bruton’s tyrosine kinase inhibitor: Mass balance, elimination route, and metabolism in healthy participants
Clinical and Translational Science2021-08-1016 citations
Brain-homing B cells in multiple sclerosis: association with Bruton’s tyrosine kinase and targeting by evobrutinib (4095)
Neurology2021-04-131 citations
056 Efficacy and safety of the Bruton’s tyrosine kinase inhibitor evobrutinib (M2951) in patients with relapsing multiple sclerosis over 48 weeks: a randomized, placebo-controlled, phase 2 study
Journal of Neurology Neurosurgery & Psychiatry2019-07-012 citations
Placebo-Controlled Trial of an Oral BTK Inhibitor in Multiple Sclerosis
New England Journal of Medicine2019-05-10307 citations