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A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Study acronym: AMETHYST LTE
StatusEnrolling by Invitation
PhasePhase 3
SponsorBiogen
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 53 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: details revised at 1 of 35 entriesv53
  2. Enrollment target: 322 to 306 Secondary endpoints: 41 to 35v52 Show 1 more changeShow less
    • Secondary endpoints: 41 to 35

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 103 to 104v51
  4. Study sites: 102 to 103v50
  5. Study sites: 100 to 102v49
  6. Trial sites expanded: 94 → 100 locationsv48
  7. Study sites: 93 to 94v47
  8. Study sites: 92 to 93v46
  9. Study sites: 90 to 92v45
  10. Study sites: 88 to 90v44
  11. Study sites: 87 to 88v43
  12. Study sites: 86 to 87v42
  13. Study sites: 83 to 86v41
  14. Study sites: 80 to 83v40
  15. Study sites: 74 to 80v39
  16. Secondary endpoints: details revised at 1 of 41 entriesv38
  17. Study sites: 73 to 74v37
  18. Secondary endpoints: details revised at 29 of 41 entriesv36
  19. Study sites: 72 to 73 Secondary endpoints: details revised at 29 of 41 entriesv35 Show 1 more changeShow less
    • Secondary endpoints: details revised at 29 of 41 entries
  20. Study sites: 71 to 72v34
  21. Study sites: 70 to 71v33
  22. Study sites: 69 to 70v32
  23. Study sites: 67 to 69v31
  24. Study sites: 62 to 67v30
  25. Study sites: 60 to 62v29
  26. Study sites: 59 to 60v28
  27. Study sites: 57 to 59v27
  28. Study sites: 51 to 57 Study title shortened, about 2 wordsv26 Show 1 more changeShow less
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  29. Study sites: 47 to 51v25
  30. Study sites: 45 to 47v24
  31. Study sites: 44 to 45v23
  32. Study sites: 40 to 44v22
  33. Study sites: 36 to 40v21
  34. Study sites: 32 to 36v20
  35. Eligibility criteria revised Secondary endpoints: 38 to 41 · Study description expanded, about 151 words · Study title shortened, about 6 wordsv19 Show 3 more changesShow less
    • Secondary endpoints: 38 to 41
    • Study description expanded, about 151 words
    • Study title shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  36. Study sites: 29 to 32v18
  37. Study sites: 27 to 29v17
  38. Study sites: 24 to 27v16
  39. Study sites: 23 to 24v15
  40. Study sites: 22 to 23v14
  41. Study sites: 19 to 22v13
  42. Study sites: 16 to 19v12
  43. Study sites: 15 to 16v11
  44. Study sites: 11 to 15v10
  45. Study sites: 10 to 11v9
  46. Study sites: 6 to 10v8
  47. Study sites: 5 to 6v7
  48. Study sites: 4 to 5v6
  49. Study sites: 2 to 4v5
  50. Study sites: 1 to 2v4
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Biogen
92 trials monitored
See 7 trials at risk
Lupus (SLE)
651 trials monitored
See 25 trials at risk
In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301. The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is: * How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are health problems that may or may not be caused by the study drug. Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab. The study will be done as follows: * The last visit of parent study 230LE301 will be the first visit of study 230LE305. * All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug. * Globally, the treatment period will last up to 208 weeks, or 4 years. Participants will have up to 53 study visits during this time.
Trial Details
NCT Number NCT06044337
Lead Sponsor Biogen
Conditions Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
Enrollment 306 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov