Study of M5049 in CLE and SLE Participants

  • STATUS
    Recruiting
  • End date
    Mar 4, 2022
  • participants needed
    44
  • sponsor
    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Updated on 5 August 2021
lupus
cutaneous lupus

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).

Details
Condition Autoimmune disease, CONNECTIVE TISSUE DISEASE, Subacute cutaneous lupus erythematosus, SYSTEMIC LUPUS ERYTHEMATOSUS, Dermatomyositis (Connective Tissue Disease), Connective Tissue Diseases, Cutaneous Lupus Erythematosus
Treatment Placebo, M5049
Clinical Study IdentifierNCT04647708
SponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Last Modified on5 August 2021

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Autoimmune or rheumatic disease other than SLE or CLE
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
Other protocol defined exclusion criteria could apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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