13 completed, 6 terminated. 11 Phase 1, 4 Phase 2, 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 11 |
| Phase 2 | 4 | Completed 2, Terminated 2 |
| Phase 3 | 4 | Terminated 4 |
Follow evobrutinib: new trials by email Literature Review of evobrutinib trials Research Report on evobrutinib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Relative Bioavailability of Evobrutinib Tablet Batches Treatment A, Treatment B, Treatment C - Healthy | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 28 | 2023-01-18 | 2025-12-23 |
| A TQT Study of Effect of M2951 on Cardiac Repolarization Placebo matched to M2951, Moxifloxacin, M2951 Low Dose - Healthy | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 36 | 2022-11-08 | 2025-11-13 |
| DDI Study of Evobrutinib and Carbamazepine Evobrutinib, Carbamazepine - Healthy | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 14 | 2022-01-13 | 2026-01-15 |
| Drug-Drug Interaction Study of Evobrutinib and Transporter Substrates Evobrutinib (45mg), Digoxin (0.25mg), Metformin (10mg) - Healthy | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 40 | 2021-10-04 | 2025-12-05 |
| Drug-drug Interaction Study of Evobrutinib With Midazolam in Healthy Participants Midazolam, M2951 - Healthy | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 16 | 2021-01-11 | 2021-03-23 |
| Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK M2951 (BTK inhibitor) - Hepatic Impairment | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 24 | 2020-09-30 | 2025-10-28 |
| Study of Evobrutinib in Participants With RMS (evolutionRMS 2) Teriflunomide, Evobrutinib - Relapsing Multiple Sclerosis | Phase 3 | Terminated | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 1166 | 2020-07-02 | 2025-03-21 |
| Study of Evobrutinib in Participants With RMS (evolutionRMS 1) Teriflunomide, Evobrutinib - Relapsing Multiple Sclerosis | Phase 3 | Terminated | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 1124 | 2020-06-12 | 2025-06-12 |
| Relative Bioavailability (rBA) of Evobrutinib Intended Commercial and Clinical Tablets, and Effect of Food on Intended Commercial Tablets Evobrutinib - Healthy | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 18 | 2020-05-25 | 2020-07-10 |
| Study of Evobrutinib in Participants With RMS Evobrutinib, Avonex®, Avonex® matched Placebo - Relapsing-remitting Multiple Sclerosis | Phase 3 | Terminated | EMD Serono Research & Development Institute, Inc. | 1 | 2019-09-10 | 2021-08-05 |
| Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS) Evobrutinib, Avonex®, Avonex® matched Placebo - Relapsing-remitting Multiple Sclerosis | Phase 3 | Terminated | EMD Serono Research & Development Institute, Inc. | 3 | 2019-08-26 | 2021-08-05 |
| Effect of Meal Composition and Timing on Evobrutinib Bioavailability Evobrutinib - Healthy | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 20 | 2019-04-15 | 2020-07-07 |
| Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib Evobrutinib - Healthy | Phase 1 | Completed | Merck KGaA, Darmstadt, Germany | 6 | 2018-10-30 | 2020-07-07 |
| Effect of Renal Impairment on Evobrutinib Pharmacokinetics (PK) Evobrutinib - Renal Impairment | Phase 1 | Completed | Merck KGaA, Darmstadt, Germany | 31 | 2018-03-21 | 2019-05-16 |
| Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis M2591 25 mg QD, M2951 75 mg QD, M2951 50 mg BID - Rheumatoid Arthritis | Phase 2 | Completed | EMD Serono Research & Development Institute, Inc. | 390 | 2017-09-18 | 2020-09-28 |
| A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis Evobrutinib, Placebo, Tecfidera - Relapsing-remitting Multiple Sclerosis | Phase 2 | Terminated | EMD Serono Research & Development Institute, Inc. | 267 | 2017-03-07 | 2025-05-14 |
| A Phase II Study of M2951 in SLE Placebo, M2951 - Systemic Lupus Erythematosus | Phase 2 | Terminated | EMD Serono Research & Development Institute, Inc. | 469 | 2017-01-04 | 2021-04-12 |
| Safety and Efficacy Study of M2951 in Participants With Rheumatoid Arthritis Placebo, M2951 - Rheumatoid Arthritis | Phase 2 | Completed | EMD Serono Research & Development Institute, Inc. | 65 | 2016-07-31 | 2018-07-17 |
| MSC2364447C Phase 1b in Systemic Lupus Erythematosus MSC2364447C, Placebo - Lupus Erythematosus, Systemic | Phase 1 | Completed | EMD Serono Research & Development Institute, Inc. | 24 | 2015-11-30 | 2017-10-09 |
Multiple Sclerosis, Relapsing-Remitting (3) · Arthritis, Rheumatoid (2) · Lupus Erythematosus, Systemic (2) · Autoimmune Diseases (1) · Renal Insufficiency (1)
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (10) · EMD Serono Research & Development Institute, Inc. (7) · Merck KGaA, Darmstadt, Germany (2)
Germany (15) · United States (8) · Bulgaria (6) · Poland (5) · Russia (5) · Ukraine (4) · Argentina (3) · Colombia (3) · Czechia (3) · Italy (3) · Mexico (3) · Serbia (3) · South Africa (3) · Spain (3) · Canada (2)
PMID 36418156, PMID 37345645, PMID 39307151, PMID 31075187, PMID 33687069, PMID 36126241, PMID 37626477, PMID 38335474
2019 (4), 2016 (3), 2018 (3), 2017 (2), 2015 (1)