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5 Diseases |  |
3 Trials |
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3 Trials |  |
423 News |  |
| «123456» |
- evobrutinib (M2951) / EMD Serono
Rationale and Design of two Phase 3 Randomized Controlled Trials (Evolution RMS 1&2) Evaluating the Bruton’s Tyrosine Kinase Inhibitor Evobrutinib in Patients with Relapsing Multiple Sclerosis () - Jan 21, 2020 - Abstract #AAN2020AAN_3210;
P3
These two Phase 3 RCTs will determine the efficacy and safety of evobrutinib and assess its impact on PROs compared to an established standard of care (teriflunomide) in patients with relapsing forms of RMS.
- evobrutinib (M2951) / EMD Serono
The Bruton’s Tyrosine Kinase Inhibitor Evobrutinib Ameliorates Meningeal Inflammation in Experimental Autoimmune Encephalomyelitis (EAE) () - Jan 21, 2020 - Abstract #AAN2020AAN_2181;
These two Phase 3 RCTs will determine the efficacy and safety of evobrutinib and assess its impact on PROs compared to an established standard of care (teriflunomide) in patients with relapsing forms of RMS. An amelioration of established meningeal inflammation in the relapsing-remitting EAE model was observed with evobrutinib treatment, suggesting the potential utility of this agent to target this phenomenon in MS patients.
- | evobrutinib (M2951) / EMD Serono
Journal: Simultaneous determination of evobrutinib and its metabolite evobrutinib-diol in dog plasma by liquid chromatography combined with electrospray ionization tandem mass spectrometry. (Pubmed Central) - Jan 8, 2020
The extraction recovery was larger than 85.41% and no significant matrix effect was observed. The developed assay was successfully applied to the pharmacokinetic study of evobrutinib and evobrutinib-diol in dogs after oral administration of evobrutinib at a single dose of 5 mg/kg.
- || evobrutinib (M2951) / EMD Serono
Clinical, PK/PD data, Journal: Efficacy and Pharmacodynamic Modeling of the BTK Inhibitor Evobrutinib in Autoimmune Disease Models. (Pubmed Central) - Jan 1, 2020
Thus, evobrutinib achieves efficacy by acting both on B cells and innate immune cells. Taken together, our data show that evobrutinib is a promising molecule for the chronic treatment of B cell-driven autoimmune disorders.
- || evobrutinib (M2951) / EMD Serono
New P1 trial: MS200527_0072: Effect of Meal Composition and Timing on Evobrutinib Bioavailability (clinicaltrials.gov) - Dec 15, 2019
P1, N=20, Completed, Sponsor: Merck KGaA, Darmstadt, Germany
- | Journal: Oral Bruton tyrosine kinase inhibitors block activation of the platelet Fc receptor CD32a (FcγRIIA): a new option in HIT? (Pubmed Central) - Dec 7, 2019
Thus, irreversible and reversible BTKi's potently inhibit platelet activation by FcγRIIA in blood. This new rationale deserves testing in patients with HIT.
- |||| evobrutinib (M2951) / EMD Serono
Trial completion: MS200527-0060: Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - Nov 15, 2019
P2b, N=390, Completed, Sponsor: EMD Serono Research & Development Institute, Inc.
This new rationale deserves testing in patients with HIT. Active, not recruiting --> Completed
- | evobrutinib (M2951) / EMD Serono, Rebif (human IFN-?-1a) / EMD Serono
Enrollment open, Trial primary completion date: EVOLUTION MS1: Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS) (clinicaltrials.gov) - Sep 23, 2019
P3, N=950, Recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
Active, not recruiting --> Completed Not yet recruiting --> Recruiting | Trial primary completion date: Oct 2026 --> Sep 2023
- | evobrutinib (M2951) / EMD Serono
Enrollment closed: MS200527-0018: A Phase II Study of M2951 in SLE (clinicaltrials.gov) - Sep 16, 2019
P2, N=480, Active, not recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
Not yet recruiting --> Recruiting | Trial primary completion date: Oct 2026 --> Sep 2023 Recruiting --> Active, not recruiting
- || Arzerra (ofatumumab) / Novartis, Genmab, evobrutinib (M2951) / EMD Serono, Ocrevus (ocrelizumab) / Roche, Biogen
Two new MS drugs targeting B cells available soon: evobrutinib and ofatumumab. Like Ocrevus but may offer advantages. #ECTRIMS2019 #MS (Twitter) - Sep 13, 2019
- Tecfidera (dimethyl fumarate) / Biogen, evobrutinib (M2951) / EMD Serono
Effect of evobrutinib, a Bruton's tyrosine kinase inhibitor, on immune cell and immunoglobulin levels over 48 weeks in a phase 2 study in relapsing multiple sclerosis (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1114;
P2
IgG levels remained stable and slight elevations in IgA levels were observed with evobrutinib. These new findings demonstrate that, in contrast to genetic deletion of BTK, continued pharmacological BTK inhibition does not lead to B cell depletion or significant reductions in circulating immunoglobulins.
- evobrutinib (M2951) / EMD Serono
Inhibition of Bruton's Tyrosine Kinase Selectively Prevents Antigen-Activation of B cells and Ameliorates B cell-Mediated Experimental Autoimmune Encephalomyelitis (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_291;
Evobrutinib efficiently reduces BTK-dependent signaling after BCR stimulation, preventing B cell activation, pro-inflammatory differentiation and function. This translates into reduced CNS inflammation and clinical amelioration in a B cell-mediated EAE model.
- | evobrutinib (M2951) / EMD Serono, Rebif (human IFN-?-1a) / EMD Serono
New P3 trial: EVOLUTION MS1: Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS) (clinicaltrials.gov) - Jul 24, 2019
P3, N=950, Not yet recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
- | evobrutinib (M2951) / EMD Serono, Rebif (human IFN-?-1a) / EMD Serono
New P3 trial: EVOLUTION MS2: Study of Evobrutinib in Participants With RMS (clinicaltrials.gov) - Jul 24, 2019
P3, N=950, Not yet recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
- | Journal: Optimizing Platelet GPVI Inhibition versus Haemostatic Impairment by the Btk Inhibitors Ibrutinib, Acalabrutinib, ONO/GS-4059, BGB-3111 and Evobrutinib. (Pubmed Central) - Jul 11, 2019
Prolonging platelet drug exposure to 60 minutes lowered IC values of any Btk inhibitor for GPVI-mediated aggregation by several fold, and 5- to 10-fold below anti-proliferative therapeutic drug plasma levels. In conclusion, low blood concentrations of ibrutinib and the novel Btk inhibitors suffice for GPVI selective platelet inhibition relevant for atherothrombosis but do not impair primary haemostasis.
- | Rituxan (rituximab) / Roche, Biogen
Review, Journal: Therapies for multiple sclerosis targeting B cells. (Pubmed Central) - Jul 6, 2019
On the other hand, targeting B cell cytokines with the fusion protein atacicept increased MS activity, highlighting the complex and not fully understood role of B cells and humoral immunity in MS. Finally, all other approved therapies for MS, some of which have been designed to target T cells, have some effects on the frequency, phenotype, or homing of B cells, which may contribute to their therapeutic activity.
- | Tecfidera (dimethyl fumarate) / Biogen
Clinical, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: Placebo-Controlled Trial of an Oral BTK Inhibitor in Multiple Sclerosis. (Pubmed Central) - Jul 5, 2019
P2
Longer and larger trials are required to determine the effect and risks of evobrutinib in patients with multiple sclerosis. (Funded by EMD Serono; ClinicalTrials.gov number, NCT02975349.).
- | evobrutinib (M2951) / EMD Serono
Enrollment closed, Trial primary completion date: MS200527-0060: Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - Jul 2, 2019
P2b, N=390, Active, not recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
(Funded by EMD Serono; ClinicalTrials.gov number, NCT02975349.). Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2019 --> Oct 2019
- ||||| evobrutinib (M2951) / EMD Serono, fenebrutinib (GDC-0853) / Roche
Multitarget therapy for #Lupus under development 👉🏻 Fenebrutinib @Roche 👉🏻 Evobrutinib @MerckHealthcare 👉🏻 Spleen Kinase Inhibitors @GileadSciences @RigelPharma 👉🏻 Encoding transcription factors @Celgene 👉🏻 JAK/Tyk Inhibitors @PfizerCongress @LillyRheumEU @bmsnews @GSK #EULAR2019 (Twitter) - Jun 13, 2019
- |||| evobrutinib (M2951) / EMD Serono
Clinical: @MarTintore Un nuevo lanzamiento para la esclerosis múltiple: el Evobrutinib pasará a la Fase 3 👉reducción BID en lesiones T1 Gd+ vs placebo + #neuroup2019 (Twitter) - May 31, 2019
- | evobrutinib (M2951) / EMD Serono
Trial completion: MS200527_0072: Effect of Meal Composition and Timing on Evobrutinib Bioavailability (clinicaltrials.gov) - May 28, 2019
P1, N=20, Completed, Sponsor: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2019 --> Oct 2019 Recruiting --> Completed
- | evobrutinib (M2951) / EMD Serono
P2 data, Journal: Phase II trial of evobrutinib in multiple sclerosis. (Pubmed Central) - May 28, 2019
Recruiting --> Completed No abstract available
- | evobrutinib (M2951) / EMD Serono
Latest Data on Evobrutinib, New MS Therapy Targeting B Cells https://t.co/YqwjJV6c56 vía @medscape (Twitter) - May 24, 2019
- ||| evobrutinib (M2951) / EMD Serono
SM, evobrutinib: lesioni RM Gd-captanti ridotte con 75 mg unum/die #AAN2019 https://t.co/5rcgV6oEku (Twitter) - May 19, 2019
- | evobrutinib (M2951) / EMD Serono
Trial completion: MS200527_0026: Effect of Renal Impairment on Evobrutinib Pharmacokinetics (PK) (clinicaltrials.gov) - May 16, 2019
P1, N=31, Completed, Sponsor: Merck KGaA, Darmstadt, Germany
No abstract available Recruiting --> Completed
- | evobrutinib (M2951) / EMD Serono
Preclinical, Journal: Identification of metabolites of evobrutinib in rat and human hepatocytes by using ultra-high performance liquid chromatography coupled with diode array detector and Q Exactive Orbitrap tandem mass spectrometry. (Pubmed Central) - May 15, 2019
M15 was the most abundant metabolite whereas M13 was the minor metabolite in human hepatocytes. This study provides preliminary information regarding the metabolism of evobrutinib that may be helpful in understanding the pharmacology of evobrutinib.
- || evobrutinib (M2951) / EMD Serono
Un estudio liderado por el Dr. @XMontalban demuestra que #evobrutinib reduce las lesiones cerebrales en la #esclerosismultiple recurrente @cemcat_em @vallhebron @VHIR_ @merck_es https://t.co/ljl6JdcJvZ (Twitter) - May 13, 2019
- ||| evobrutinib (M2951) / EMD Serono
Un estudio liderado por el Dr. @XMontalban demuestra que evobrutinib, un inhibidor oral de BTK, reduce rápidamente las lesiones cerebrales en #EsclerosisMúltiple. Publicado hoy en @NEJM @cemcat_em @VHIR_ https://t.co/vqVWwhqjGa (Twitter) - May 10, 2019
- | evobrutinib (M2951) / EMD Serono
New P1 trial: MS200527_0072: Effect of Meal Composition and Timing on Evobrutinib Bioavailability (clinicaltrials.gov) - May 1, 2019
P1, N=20, Recruiting, Sponsor: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- | evobrutinib (M2951) / EMD Serono
Trial completion date: MS200527-0060: Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - Apr 25, 2019
P2b, N=360, Recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
This study provides preliminary information regarding the metabolism of evobrutinib that may be helpful in understanding the pharmacology of evobrutinib. Trial completion date: Jul 2020 --> Oct 2019
- | evobrutinib (M2951) / EMD Serono
Trial completion: MS200527_0075: Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib (clinicaltrials.gov) - Feb 26, 2019
P1, N=6, Completed, Sponsor: Merck KGaA, Darmstadt, Germany
Trial completion date: Jul 2020 --> Oct 2019 Recruiting --> Completed
- | evobrutinib (M2951) / EMD Serono
Enrollment open, Trial completion date, Trial primary completion date: MS200527_0026: Effect of Renal Impairment on Evobrutinib Pharmacokinetics (PK) (clinicaltrials.gov) - Nov 28, 2018
P1, N=32, Recruiting, Sponsor: Merck KGaA
Recruiting --> Completed Completed --> Recruiting | Trial completion date: Jun 2018 --> Feb 2019 | Trial primary completion date: Jun 2018 --> Feb 2019
- | evobrutinib (M2951) / EMD Serono
Enrollment open: MS200527_0075: Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib (clinicaltrials.gov) - Nov 26, 2018
P1, N=6, Recruiting, Sponsor: Merck KGaA
Completed --> Recruiting | Trial completion date: Jun 2018 --> Feb 2019 | Trial primary completion date: Jun 2018 --> Feb 2019 Not yet recruiting --> Recruiting
- | evobrutinib (M2951) / EMD Serono
New P1 trial: MS200527_0075: Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib (clinicaltrials.gov) - Oct 29, 2018
P1, N=6, Not yet recruiting, Sponsor: Merck KGaA
- | evobrutinib (M2951) / EMD Serono
Trial completion, Trial completion date, Trial primary completion date: MS200527_0026: Effect of Renal Impairment on Evobrutinib Pharmacokinetics (PK) (clinicaltrials.gov) - Aug 3, 2018
P1, N=32, Completed, Sponsor: Merck KGaA
Not yet recruiting --> Recruiting Recruiting --> Completed | Trial completion date: Dec 2018 --> Jun 2018 | Trial primary completion date: Dec 2018 --> Jun 2018
- || evobrutinib (M2951) / EMD Serono
Trial completion date: MS200527-0018: A Phase II Study of M2951 in SLE (clinicaltrials.gov) - Jun 26, 2018
P2, N=451, Recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
Recruiting --> Completed | Trial completion date: Dec 2018 --> Jun 2018 | Trial primary completion date: Dec 2018 --> Jun 2018 Trial completion date: Jul 2020 --> Jul 2022
- || evobrutinib (M2951) / EMD Serono
Trial completion date, Trial primary completion date: MS200527-0086: A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis (clinicaltrials.gov) - Apr 10, 2018
P2, N=267, Active, not recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
Trial completion date: Jul 2020 --> Jul 2022 Trial completion date: Feb 2019 --> Aug 2020 | Trial primary completion date: Feb 2019 --> Jan 2018
- evobrutinib (M2951) / EMD Serono
Enrollment open: MS200527_0026: Effect of Renal Impairment on Evobrutinib Pharmacokinetics (PK) (clinicaltrials.gov) - Apr 4, 2018
P1, N=32, Recruiting, Sponsor: Merck KGaA
Trial completion date: Feb 2019 --> Aug 2020 | Trial primary completion date: Feb 2019 --> Jan 2018 Not yet recruiting --> Recruiting
- || evobrutinib (M2951) / EMD Serono
Trial completion date, Trial primary completion date: MS200527-0060: Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - Mar 3, 2018
P2b, N=360, Recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
Not yet recruiting --> Recruiting Trial completion date: Apr 2021 --> Apr 2021 | Trial primary completion date: Mar 2019 --> Feb 2019
- | evobrutinib (M2951) / EMD Serono
New P1 trial: MS200527_0026: Effect of Renal Impairment on Evobrutinib Pharmacokinetics (PK) (clinicaltrials.gov) - Feb 19, 2018
P1, N=32, Not yet recruiting, Sponsor: Merck KGaA
- |||| evobrutinib (M2951) / EMD Serono
Trial completion: MS200527-0081: Safety and Efficacy Study of M2951 in Participants With Rheumatoid Arthritis (clinicaltrials.gov) - Nov 29, 2017
P2a, N=65, Completed, Sponsor: EMD Serono Research & Development Institute, Inc.
Trial completion date: Apr 2021 --> Apr 2021 | Trial primary completion date: Mar 2019 --> Feb 2019 Active, not recruiting --> Completed
- |||| evobrutinib (M2951) / EMD Serono
Enrollment open: MS200527-0060: Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - Sep 14, 2017
P2b, N=360, Recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- ||| evobrutinib (M2951) / EMD Serono
Enrollment closed: MS200527-0086: A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis (clinicaltrials.gov) - Sep 6, 2017
P2, N=267, Active, not recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- |||||| evobrutinib (M2951) / EMD Serono
New P2b trial: MS200527-0060: Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - Jul 27, 2017
P2b, N=360, Not yet recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
- |||| evobrutinib (M2951) / EMD Serono
Enrollment open, Trial initiation date: MS200527-0086: A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis (clinicaltrials.gov) - Apr 19, 2017
P2, N=250, Recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Initiation date: Jan 2017 --> Apr 2017
- ||| evobrutinib (M2951) / EMD Serono
Enrollment closed, Trial primary completion date: MS200527-0081: Safety and Efficacy Study of M2951 in Participants With Rheumatoid Arthritis (clinicaltrials.gov) - Feb 27, 2017
P2a, N=65, Active, not recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
Not yet recruiting --> Recruiting | Initiation date: Jan 2017 --> Apr 2017 Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2017 --> Apr 2017
- |||| evobrutinib (M2951) / EMD Serono
Enrollment open: MS200527-0018: A Phase II Study of M2951 in SLE (clinicaltrials.gov) - Jan 30, 2017
P2, N=432, Recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2017 --> Apr 2017 Not yet recruiting --> Recruiting
- || evobrutinib (M2951) / EMD Serono
Trial primary completion date: MS200527-0081: Safety and Efficacy Study of M2951 in Participants With Rheumatoid Arthritis (clinicaltrials.gov) - Dec 8, 2016
P2a, N=64, Recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.
Not yet recruiting --> Recruiting Trial primary completion date: May 2017 --> Sep 2017
- | evobrutinib (M2951) / EMD Serono
Trial completion: EMR200527-002: MSC2364447C Phase 1b in Systemic Lupus Erythematosus (clinicaltrials.gov) - Nov 29, 2016
P1b, N=24, Completed, Sponsor: EMD Serono Research & Development Institute, Inc.
Trial primary completion date: May 2017 --> Sep 2017 Recruiting --> Completed
- ||||| evobrutinib (M2951) / EMD Serono
New P2 trial: MS200527-0018: A Phase II Study of M2951 in SLE (clinicaltrials.gov) - Nov 29, 2016
P2, N=432, Not yet recruiting, Sponsor: EMD Serono Research & Development Institute, Inc.