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A Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and it's Effects on Symptoms in Adults With Systemic Lupus Erythematosus (SLE)

Study acronym: EMERALD
StatusEnrolling by Invitation
PhasePhase 3
SponsorBiogen
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 1 month later Mar 29, 2030 → May 3, 2032
See other at-risk trials from Biogen

Record History

The 50 most recent of 78 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study sites: 213 to 214
  2. Primary and study completion pushed from Mar 29, 2030 to May 3, 2032 Study sites: 211 to 213 · Secondary endpoints: details revised at 22 of 22 entries · Study description revised · 2 more Show 5 more changesShow less
    • Study sites: 211 to 213
    • Secondary endpoints: details revised at 22 of 22 entries
    • Study description revised
    • Eligibility criteria expanded, about 5 words
    • Study title shortened, about 3 words
  3. Study sites: 210 to 211v76
  4. Trial sites expanded: 206 → 210 locationsv75
  5. Study sites: 205 to 206v74
  6. Study sites: 203 to 205v73
  7. Trial sites expanded: 197 → 203 locationsv72
  8. Study sites: 196 to 197v71
  9. Study sites: 195 to 196v70
  10. Study sites: 194 to 195v69
  11. Trial sites expanded: 191 → 194 locationsv68
  12. Study sites: 190 to 191v67
  13. Study sites: 188 to 190v66
  14. Study sites: 186 to 188v65
  15. Re-verified, no change to tracked fieldsv64
  16. Study sites: 185 to 186v63
  17. Study sites: 183 to 185v62
  18. Study sites: 182 to 183v61
  19. Study sites: 181 to 182v60
  20. Study sites: 180 to 181v59
  21. Study sites: 179 to 180v58
  22. Study sites: 178 to 179v57
  23. Study sites: 174 to 178v56
  24. Study sites: 173 to 174v55
  25. Study sites: 160 to 173v54
  26. Eligibility criteria revised Study description expanded, about 90 wordsv53 Show 1 more changeShow less
    • Study description expanded, about 90 words

    See this version in full on ClinicalTrials.gov ↗

  27. Study sites: 158 to 160v52
  28. Study sites: 157 to 158v51
  29. Study sites: 156 to 157v50
  30. Study sites: 155 to 156v49
  31. Study sites: 153 to 155v48
  32. Study sites: 151 to 153v47
  33. Study sites: 150 to 151v46
  34. Study sites: 149 to 150v45
  35. Study sites: 148 to 149v44
  36. Study sites: 147 to 148v43
  37. Study sites: 145 to 147v42
  38. Study sites: 144 to 145v41
  39. Study sites: 143 to 144v40
  40. Study sites: 141 to 143v39
  41. Study sites: 140 to 141v38
  42. Study sites: 135 to 140v37
  43. Study sites: 131 to 135v36
  44. Study sites: 130 to 131v35
  45. Study sites: 128 to 130v34
  46. Study sites: 126 to 128v33
  47. Study sites: 125 to 126v32
  48. Re-verified, no change to tracked fieldsv31
  49. Study sites: 120 to 125v30
  50. Primary and study completion dates: Mar 13, 2029 to Mar 29, 2030v29
  • 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 litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on adults who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will include participants who completed the treatment periods of either one of those parent studies. The main goal of the study is to learn more about the long-term safety of litifilimab in adults. The main question researchers want to answer is: \- How many participants have adverse events and serious adverse events during the study? Adverse events are health problems that may or may not be caused by the study drug. Researchers will also learn about: * The effect of litifilimab on controlling symptoms of SLE and lowering its activity. * How participants' immune systems respond to litifilimab. * The effect of litifilimab on the quality of life of participants. The study will be done as follows: * This study begins when the participant has finished 1 of the parent studies (either 230LE303 or 230LE304). * Participants who were getting either a high or low dose of litifilimab in either parent study will continue getting the same doses. * Participants who were getting the placebo in the parent studies will be randomized to get either a high or low dose of litifilimab. * Neither the researchers nor the participants will know which doses of litifilimab the participants are getting. * All participants will get litifilimab as injections under the skin once every 4 weeks. The treatment period will last up to 260 weeks. Participants may continue to take their standard of care medications. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 73 study visits. At these visits, the study doctor will do tests to check the participants' overall health, including the status of their SLE symptoms. They will also measure the participants' height, weight, and vital signs and collect blood and urine samples. Participants will also complete questionnaires or answer questions about how they are feeling and about their daily lives. * Each participant will be in the study for up to 284 weeks. Optional Substudy: * Some participants may be invited to join an optional "substudy" after being in the main study for at least 4 months. * This substudy will test a new injector device for delivering litifilimab. The injector device is an automatic device that delivers the full dose in 1 injection without needing to push a plunger. * Researchers will learn more about the safety of the injector device and how the body reacts to it. This will be compared to the current prefilled syringe method. * The substudy will last up to 3 months and will include about 120 participants.
Trial Details
NCT Number NCT05352919
Lead Sponsor Biogen
Conditions Systemic Lupus Erythematosus (SLE)
Enrollment 864 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov