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Enpatoran · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Enpatoran | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Enpatoran | DRUG | Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168. |
| Placebo | DRUG | Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168. |
| Standard of care (SoC) | DRUG | Participants will receive Investigator-recommended SoC. |
Inclusion Criteria * Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory. * Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medic...
Enpatoran is an investigational small molecule being studied for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE), including cutaneous manifestations of lupus with or without systemic disease. It is also used in early-phase studies involving healthy participants to evaluate drug properties.
Enpatoran is a small molecule immunology therapy in development for lupus. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for its effects on immune pathways involved in systemic and cutaneous lupus.
Enpatoran is being developed by Merck KGaA, a German pharmaceutical company. The company is conducting clinical trials of Enpatoran across multiple countries, including the United States, Canada, China, Germany, and Switzerland.
Enpatoran is currently in Phase 3 clinical development. A Phase 3 trial, ELOWEN-2, is recruiting participants with cutaneous manifestations of lupus with or without systemic disease. Earlier Phase 1 and Phase 2 studies have been completed.
Enpatoran has been studied in several clinical trials. The WILLOW study (NCT05162586) was a completed Phase 2 trial in systemic lupus erythematosus. The ELOWEN-2 study (NCT07355218) is a recruiting Phase 3 trial in cutaneous lupus. Phase 1 trials include NCT05110027 and NCT06589726 in healthy participants.
Yes, Enpatoran is also known as M5049. The WILLOW study, a completed Phase 2 trial in systemic lupus erythematosus, used the name M5049 in its title. Both names refer to the same investigational drug being developed by Merck KGaA.