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Study of M5049 in CLE and SLE Participants

NCT04647708 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-02-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2023-12-19
Completion
2023-12-19

Countries

  • Bulgaria
  • Germany
  • Moldova
  • North Macedonia
  • Spain
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04647708 on ClinicalTrials.gov