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M5049 · 2 trials · 3 indications
Number of participants with clinically significant changes will be reported.
Number of participants with clinically significant changes will be reported.
| Arm | Type | Description |
|---|---|---|
| Part A (Cohort 1): M5049 Dose A | EXPERIMENTAL | - |
| Part A (Cohort 2): M5049 Dose B | EXPERIMENTAL | - |
| Part A (Cohort 3): M5049 Dose C | EXPERIMENTAL | - |
| Part A (Cohort 4): M5049 Dose D | EXPERIMENTAL | - |
| Part A: Placebo | PLACEBO_COMPARATOR | - |
| Part B (Cohort 5): M5049 Dose E | EXPERIMENTAL | - |
| Part B: Placebo | PLACEBO_COMPARATOR | - |
| Part A: M5049 | EXPERIMENTAL | - |
| Part B: M5049 | EXPERIMENTAL | - |
| Part C: M5049 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| M5049 | DRUG | Participants will receive low oral dose of M5049, twice daily in Part A. |
| Placebo | DRUG | Participants will receive placebo matched to M5049. |
Inclusion Criteria: * Active systemic lupus erythematosus (SLE) with a Cutaneous lupus erythematosus disease area and activity index (CLASI-A) greater than or equal to \[\>= \] 6 and/or at least one active SLE clinical manifestation according to Systemic Lupus Erythematosus Disease Activity Index 2...
M5049 is an investigational small molecule being studied for Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE). It has also been evaluated in healthy participants to assess safety and tolerability. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
M5049 is being developed by Merck KGaA, a science and technology company. The company's stock is traded over-the-counter under the ticker MKGAF. Merck KGaA is conducting clinical trials to evaluate the safety and efficacy of M5049 in lupus indications.
M5049 is in Phase 1 clinical development. Two Phase 1 trials have been completed: one in healthy participants and one in participants with Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus. The drug remains investigational and has not received FDA approval.
M5049 has been studied in two completed Phase 1 trials. NCT03676322 was a single and multiple ascending dose study in 96 healthy participants in Germany. NCT04647708 evaluated M5049 in 25 participants with Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus across multiple European countries.
No alternative names for M5049 have been disclosed. The drug is identified solely by its code name M5049 in clinical trial registrations and development documentation. It is a distinct investigational small molecule being developed by Merck KGaA.