Evobrutinib

Generic Name: Evobrutinib

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₂₇N_₅O_₂

CAS Number: 1415823-73-2

Unique Ingredient Identifier: ZA45457L1K

Background: Evobrutinib is under investigation in clinical trial NCT03934502 (Effect of Meal Composition and Timing on Evobrutinib Bioavailability).

Associated Conditions: -

Associated Therapies: -

Clinical Trials

DDI Study of Evobrutinib and Carbamazepine

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Evobrutinib
Drug: Carbamazepine

First Posted Date: 2022-02-21

Last Posted Date: 2022-08-22

Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Target Recruit Count: 14

Registration Number: NCT05248945

Locations: 🇩🇪
Nuvisan GmbH, Neu-Ulm, Bavaria, Germany

Drug-Drug Interaction Study of Evobrutinib and Transporter Substrates

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Evobrutinib
Drug: Digoxin
Drug: Sumatriptan
Drug: Metformin
Drug: Rosuvastatin

First Posted Date: 2021-10-01

Last Posted Date: 2022-01-11

Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Target Recruit Count: 40

Registration Number: NCT05064488

Locations: 🇩🇪
Nuvisan GmbH, Neu-Ulm, Germany

Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

Phase 3

Terminated

Conditions: Relapsing Multiple Sclerosis

Interventions: Drug: Teriflunomide
Drug: Evobrutinib
Drug: Placebo (match to Evobrutinib)
Drug: Placebo (match to Teriflunomide)

First Posted Date: 2020-04-08

Last Posted Date: 2024-04-29

Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Target Recruit Count: 1124

Registration Number: NCT04338022

Locations: 🇺🇸
Research Site 612, Farmington Hills, Michigan, United States
🇦🇹
Research Site 151, Innsbruck, Austria
🇦🇹
Research Site 153, Vienna, Austria

and more 276 locations

Study of Evobrutinib in Participants With RMS (evolutionRMS 2)

Phase 3

Terminated

Conditions: Relapsing Multiple Sclerosis

Interventions: Drug: Evobrutinib
Drug: Teriflunomide
Drug: Placebo (match to Teriflunomide)
Drug: Placebo (match to Evobrutinib)

First Posted Date: 2020-04-08

Last Posted Date: 2024-04-29

Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Target Recruit Count: 1124

Registration Number: NCT04338061

Locations: 🇺🇸
Research Site 736, Asheville, North Carolina, United States
🇺🇸
Research Site 748, Philadelphia, Pennsylvania, United States
🇺🇸
Research Site 719, Sarasota, Florida, United States

and more 273 locations

Relative Bioavailability (rBA) of Evobrutinib Intended Commercial and Clinical Tablets, and Effect of Food on Intended Commercial Tablets

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Evobrutinib

First Posted Date: 2020-03-18

Last Posted Date: 2020-07-10

Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Target Recruit Count: 18

Registration Number: NCT04314024

Locations: 🇩🇪
Nuvisan GmbH, Neu-Ulm, Germany

Study of Evobrutinib in Participants With RMS

Phase 3

Terminated

Conditions: Relapsing-remitting Multiple Sclerosis

Interventions: Drug: Evobrutinib
Drug: Avonex®
Drug: Avonex® matched Placebo
Drug: Evobrutinib matched Placebo

First Posted Date: 2019-07-25

Last Posted Date: 2021-08-05

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 1

Registration Number: NCT04032171

Locations: 🇺🇸
Please Contact U.S. Medical Information, Rockland, Massachusetts, United States
🇩🇪
Please Contact the Communication Center, Darmstadt, Germany

Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)

Phase 3

Terminated

Conditions: Relapsing-remitting Multiple Sclerosis

Interventions: Drug: Avonex®
Drug: Evobrutinib
Drug: Evobrutinib matched Placebo
Drug: Avonex® matched Placebo

First Posted Date: 2019-07-25

Last Posted Date: 2021-08-05

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 3

Registration Number: NCT04032158

Locations: 🇺🇸
Please Contact U.S. Medical Information, Rockland, Massachusetts, United States
🇩🇪
Please Contact the Communication Center, Darmstadt, Germany

Effect of Meal Composition and Timing on Evobrutinib Bioavailability

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Evobrutinib

First Posted Date: 2019-05-02

Last Posted Date: 2020-07-07

Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Target Recruit Count: 20

Registration Number: NCT03934502

Locations: 🇩🇪
Nuvisan GmbH, Neu-Ulm, Germany

Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Evobrutinib

First Posted Date: 2018-10-30

Last Posted Date: 2020-07-07

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Target Recruit Count: 6

Registration Number: NCT03725072

Locations: 🇳🇱
PRA Health Sciences, Groningen, Netherlands

Effect of Renal Impairment on Evobrutinib Pharmacokinetics (PK)

Phase 1

Completed

Conditions: Renal Impairment

Interventions: Drug: Evobrutinib

First Posted Date: 2018-02-19

Last Posted Date: 2019-05-16

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Target Recruit Count: 31

Registration Number: NCT03436394

Locations: 🇩🇪
Please Contact the Merck KGaA Communication Center, Darmstadt, Germany

Drug Development Updates

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