deltatrials
Completed PHASE1 INTERVENTIONAL 7-arm NCT04647708

Study of M5049 in CLE and SLE Participants

A Phase Ib, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of M5049 Administered Orally in SLE and CLE Participants Treated With Standard of Care

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

Conditions Cutaneous Lupus Erythematosus Systemic Lupus Erythematosus
Interventions M5049 Placebo
Updated 23 times since 2021 Last updated: Feb 20, 2024 Started: Dec 16, 2020 Primary completion: Dec 19, 2023 Completion: Dec 19, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus and is currently completed. Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany leads this study, which shows 23 recorded versions since 2020 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Apr 2021 · 59 days · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jul 2022 · 2 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Oct 2023 · 8 months · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Mar 2024 · 4 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

23 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Mar 2024 — Jul 2024 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  5. Nov 2023 — Mar 2024 [monthly]

    Active Not Recruiting PHASE1

▶ Show 18 earlier versions

  1. Oct 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  2. Feb 2023 — Oct 2023 [monthly]

    Recruiting PHASE1

  3. Dec 2022 — Feb 2023 [monthly]

    Recruiting PHASE1

  4. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE1

  5. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE1

  6. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE1

  7. May 2022 — Jul 2022 [monthly]

    Recruiting PHASE1

  8. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE1

  9. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE1

  10. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE1

  11. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE1

  12. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE1

  13. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE1

  14. Sep 2021 — Nov 2021 [monthly]

    Recruiting PHASE1

  15. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE1

  16. Apr 2021 — Jun 2021 [monthly]

    Recruiting PHASE1

  17. Feb 2021 — Apr 2021 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  18. Jan 2021 — Feb 2021 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Dec 2020

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Data source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations