M5049

DRUG4 trials

Sponsors

Merck KGaA, Darmstadt, Germany, EMD Serono Research & Development Institute, Inc., Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Conditions

Coronavirus Disease 2019Cutaneous Lupus ErythematosusHealthySystemic Lupus Erythematosus

Phase 1

Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of M5049 in Healthy Participants

CompletedNCT03676322

Merck KGaA, Darmstadt, GermanyHealthy

Start: 2018-09-20End: 2019-07-26Updated: 2019-12-03

Study of M5049 in CLE and SLE Participants

CompletedNCT04647708

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyCutaneous Lupus Erythematosus, Systemic Lupus Erythematosus

Start: 2020-12-16End: 2023-12-19Updated: 2024-02-21

Study of M5049 in Healthy Japanese and Caucasian Participants

CompletedNCT04880213

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyHealthy

Start: 2021-05-06End: 2021-11-23Updated: 2022-04-06

Phase 2

Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)

CompletedNCT04448756

EMD Serono Research & Development Institute, Inc.Coronavirus Disease 2019

Start: 2020-07-29End: 2021-08-16Updated: 2022-06-06

Related Papers

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.

2025-10-231 citations

P102 Safety evaluation from an ongoing randomized, double-blind, multiple-ascending dose phase Ib study of enpatoran versus placebo in patients with active systemic or cutaneous lupus erythematosus (SLE/CLE)

Poster presentations2024-03-01

Asia‐Inclusive Global Development of Enpatoran: Results of an Ethno‐Bridging Study, Intrinsic/Extrinsic Factor Assessments and Disease Trajectory Modeling to Inform Design of a Phase II Multiregional Clinical Trial

Clinical Pharmacology & Therapeutics2024-02-2816 citations

Enpatoran in <scp>COVID</scp>‐19 pneumonia: Safety and efficacy results from a phase <scp>II</scp> randomized trial

Clinical and Translational Science2023-10-2310 citations