drugset / Trial / NCT04448756
Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)
Phase 2
Completed
149 enrolled
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The study will evaluate the safety and efficacy of orally-administered M5049 in Coronavirus disease 2019 (COVID-19) pneumonia participants who are hospitalized but not on mechanical ventilation.
Timeline
- Start
- 2020-07-29
- Primary completion
- 2021-08-16
- Completion
- 2021-08-16
Publications
- McKinnon JE, Santiaguel J, Murta de Oliveira C, Yu D, Khursheed M, Moreau F, Klopp-Schulze L, Shaw J, Roy S, Kao AH; ANEMONE Study Team. Enpatoran in COVID-19 pneumonia: Safety and efficacy results from a phase II randomized trial. Clin Transl Sci. 2023 Dec;16(12):2640-2653. doi: 10.1111/cts.13658. Epub 2023 Oct 23.
- Klopp-Schulze L, Shaw JV, Dong JQ, Khandelwal A, Vazquez-Mateo C, Goteti K. Applying Modeling and Simulations for Rational Dose Selection of Novel Toll-Like Receptor 7/8 Inhibitor Enpatoran for Indications of High Medical Need. Clin Pharmacol Ther. 2022 Aug;112(2):297-306. doi: 10.1002/cpt.2606. Epub 2022 May 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enpatoran | Small molecule | 50 mg | Oral |
| Subject | Enpatoran | Small molecule | 100 mg | Oral |