For Healthcare Professionals

Study of M5049 in CLE and SLE Participants

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. 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 2000 (SLEDAI-2K)
  2. Active cutaneous lupus erythematosus (CLE) (subacute cutaneous lupus erythematosus and/or discoid lupus erythematosus) with a CLASI-A >= 6
  3. Other protocol defined inclusion criteria could apply


EXCLUSION CRITERIA

Exclusion Criteria:


  1. Autoimmune or rheumatic disease other than SLE or CLE
  2. Dermatological diseases other than cutaneous manifestations of SLE or CLE
  3. Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
  4. Ongoing or active clinically significant viral, bacterial or fungal infection
  5. History of uncontrolled seizures or other neurological disorder
  6. History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
  7. History of malignancy
  8. Other protocol defined exclusion criteria could apply


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Systemic Lupus Erythematosus,Cutaneous Lupus Erythematosus

Age (in years)

18 - 65

Phase

Phase 1

Participants needed

25

Est. Completion Date

Dec 22, 2023

Treatment type

Interventional


Sponsor

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

ClinicalTrials.gov identifier

NCT04647708

Study number

MS200569_0004

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