This is a smaller study in the realm of phase 2 versus phase 3, which we discussed before. The number of patients was much lower. We had 213 patients originally randomized. Of those, only 77% or so entered the open-label extension. Of those, 90% completed up to 108 weeks of treat...
2. Inhibition of the KCa2 potassium channel in atrial fibrillation: a randomized phase 2 trial 3. Structure-Based Design of AG-946, a Pyruvate Kinase Activator发布于 2024-01-26 13:04・IP 属地上海 药物研发 药学 新药研发 赞同1添加评论 分享喜欢收藏申请转载 ...
The Evolution RMS 1&2 trials are double-blind, double-dummy, active-controlled phase 3 studies comparing evobrutinib twice daily (BID) versus intramuscular (IM) injection of interferon β−1a once weekly. Adults ages 18–55 years with RRMS or SPMS with relapses have been recruited and ...
This same dose is being used in two phase 3 trials of the drug — nicknamed evolutionRMS 1 and evolutionRMS 2— which are currently enrolling participants. (Drugs must pass through a minimum of three trial phases before they can be approved for use.) In these studies, the safety and ...
Latest Phase 3 Findings on Evobrutinib Raise Questions About the Future of BTK Inhibitors for Multiple Sclerosisdoi:10.1097/01.NT.0001012040.34944.98Susan FitzgeraldWolters Kluwer Health, Inc.Neurology Today
Diese Phase-II-Studie untersuchte erstmals die Wirkung eines selektiven TKI in der erapie der MS. Patienten und Methodik: In diese Phase-II-Studie wurden Pati- enten mit schubförmiger MS oder sekundär chronisch-progre- dienter MS mit noch nach- Montalban X, Arnold DL, Weber weis...
2016Phase 2NCT03725072Merck KGaA, Darmstadt, GermanyHealthyOctober 30, 2018Phase 1NCT03233230EMD Serono Research & Development Institute, Inc.|Merck KGaA, Darmstadt, Germany|EMD SeronoRheumatoid ArthritisSeptember 18, 2017Phase 2NCT02975349EMD Serono Research & Development Institute, Inc.|Merck KGaA, Da...
Evobrutinib was evaluated in a double-blind, placebo-controlled, single- and multiple-ascending dose (SAD; MAD) Phase I study (see Fig. 6).36 In the SAD group, 48 healthy participants were randomized 3:1 to receive a single dose of evobrutinib (25, 50, 100, 200, 350, or 500 mg...
Objective: To analyze the safety profile, including class-related treatment-emergent adverse events (TEAEs), of evobrutinib using pooled data from phase II trials in MS, rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).Background: Evobrutinib, a highly selective oral Bruton's ...
Objective: To evaluate the effect of evobrutinib treatment versus comparator on SEL volume from baseline to Week 48 in a phase II trial.Background: Slowly expanding lesions (SELs) are chronically active, demyelinated multiple sclerosis (MS) lesions, likely driven by sustained microglia/macrophage...