Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2020-12-16
2023-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Part A (Cohort 1): M5049 Dose A
M5049
Participants will receive low oral dose of M5049, twice daily in Part A.
Part A (Cohort 2): M5049 Dose B
M5049
Participants will receive ascending oral dose of M5049, twice daily in Part A.
Part A (Cohort 3): M5049 Dose C
M5049
Participants will receive ascending oral dose of M5049, twice daily in Part A.
Part A (Cohort 4): M5049 Dose D
M5049
Participants will receive ascending oral dose of M5049, twice daily in Part A.
Part A: Placebo
Placebo
Participants will receive placebo matched to M5049.
Part B (Cohort 5): M5049 Dose E
M5049
Participants will receive high oral dose of M5049, twice daily in Part B.
Part B: Placebo
Placebo
Participants will receive placebo matched to M5049.
Interventions
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M5049
Participants will receive low oral dose of M5049, twice daily in Part A.
M5049
Participants will receive ascending oral dose of M5049, twice daily in Part A.
M5049
Participants will receive high oral dose of M5049, twice daily in Part B.
Placebo
Participants will receive placebo matched to M5049.
Eligibility Criteria
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Inclusion Criteria
* Active cutaneous lupus erythematosus (CLE) (subacute cutaneous lupus erythematosus and/or discoid lupus erythematosus) with a CLASI-A \>= 6
Exclusion Criteria
* Dermatological diseases other than cutaneous manifestations of SLE or CLE
* Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
* Ongoing or active clinically significant viral, bacterial or fungal infection
* History of uncontrolled seizures or other neurological disorder
* History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
* History of malignancy
18 Years
65 Years
ALL
No
Sponsors
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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Medical center Medconsult Pleven OOD
Pleven, , Bulgaria
Medical Center-1-Sevlievo EOOD
Sevlievo, , Bulgaria
Military Medical Academy - MHAT - Sofia
Sofia, , Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, , Bulgaria
SocraTec R&D GmbH
Erfurt, , Germany
Fraunhofer ITMP (Fraunhofer Institute for Translational Medicine and Pharmacology)
Frankfurt, , Germany
ARENSIA Exploratory Medicine Phase I Unit, Clinical Republican Hospital
Chisinau, , Moldova
PHI University Clinic of Rheumatology Skopje
Skopje, , North Macedonia
Hospital Universitario Nuestra Señora de Valme
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario Rio Hortega - Servicio de Medicina Interna
Valladolid, , Spain
Medical Center of Limited Liability Company "Harmoniya krasy", Department of clinical trials
Kyiv, , Ukraine
Countries
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References
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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.
Related Links
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Trial Awareness and Transparency website
Medical Information Location Map - Med Info Contacts
Other Identifiers
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2020-003118-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS200569_0004
Identifier Type: -
Identifier Source: org_study_id
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