NCT04647708

Study of M5049 in CLE and SLE Participants

A Phase Ib, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of M5049 Administered Orally in SLE and CLE Participants Treated With Standard of Care

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Systemic Lupus Erythematosus
• Cutaneous Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	M5049	Participants will receive low oral dose of M5049, twice daily in Part A.
DRUG	M5049	Participants will receive ascending oral dose of M5049, twice daily in Part A.
DRUG	M5049	Participants will receive high oral dose of M5049, twice daily in Part B.
DRUG	Placebo	Participants will receive placebo matched to M5049.

Timeline

• Start date: 2020-12-16
• Primary completion: 2023-12-19
• Completion: 2023-12-19
• First posted: 2020-12-01
• Last updated: 2024-02-21

Locations

12 sites across 6 countries: Bulgaria, Germany, Moldova, North Macedonia, Spain, Ukraine