drugset / Trial / NCT04647708
Study of M5049 in CLE and SLE Participants
Phase 1
Completed
25 enrolled
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
RandomizedSequentialQuadruple-blindTreatment
Summary
This study is to evaluate the safety, tolerability and pharmacokinetics (PK) of orally administered M5049 in participants with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE).
Timeline
- Start
- 2020-12-16
- Primary completion
- 2023-12-19
- Completion
- 2023-12-19
Publications
- Witte T, Fernandez-Ruiz R, Abramova N, Weinelt D, Moreau F, Klopp-Schulze L, Shaw J, Denis D, Wenzel J. Enpatoran, a first-in-class, selective, orally administered toll-like receptor 7/8 inhibitor, in systemic and cutaneous lupus erythematosus: results from a randomised, placebo-controlled phase Ib study. Lupus Sci Med. 2025 Oct 23;12(2):e001705. doi: 10.1136/lupus-2025-001705.
- 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 | — | Oral |