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A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

Study acronym: TOPAZ-1
StatusActive, Not Recruiting
PhasePhase 3
SponsorBiogen
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 10, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Secondary endpoints: 25 to 33 Study description expanded, about 172 wordsv26 Show 1 more changeShow less
    • Study description expanded, about 172 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 540 to confirmed 548 · Study sites: 169 to 164v25 Show 2 more changesShow less
    • Enrollment target: estimated 540 to confirmed 548
    • Study sites: 169 to 164
  3. Study sites: 158 to 169v24
  4. Site contacts updated at 1 of 158 sitesv23
  5. Primary completion date: Mar 28, 2025 to Sep 30, 2026 Completion date: Sep 12, 2025 to Mar 16, 2027 · Site contacts updated at 4 of 158 sitesv22 Show 2 more changesShow less
    • Completion date: Sep 12, 2025 to Mar 16, 2027
    • Site contacts updated at 4 of 158 sites
Show 20 earlier versionsHide 20 earlier versions
  1. Study sites: 136 to 158v21
  2. Site contacts updated at 1 of 136 sitesv20
  3. Study sites: 135 to 136v19
  4. Study sites: 128 to 135v18
  5. Study title shortened, about 1 wordv17 See this version in full on ClinicalTrials.gov ↗
  6. Interventions: BIIB059 (litifilimab) (Drug), Placebo (Drug) to Litifilimab (Drug), Placebo (Drug) Eligibility criteria expanded, about 11 words · Secondary endpoints revised (25) · Study title revisedv16 Show 3 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints revised (25)
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 127 to 128v15
  8. Study sites: 71 to 127v14
  9. Primary completion date: Apr 14, 2025 to Mar 28, 2025 Completion date: Sep 29, 2025 to Sep 12, 2025 · Secondary endpoints: 22 to 25 · Eligibility criteria expanded, about 4 wordsv13 Show 3 more changesShow less
    • Completion date: Sep 29, 2025 to Sep 12, 2025
    • Secondary endpoints: 22 to 25
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  10. Interventions: BIIB059 (Drug), BIIB059 matching placebo (Drug) to BIIB059 (litifilimab) (Drug), Placebo (Drug) Study title expanded, about 1 wordv12 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. Re-verified, no change to tracked fieldsv11
  12. Study Status, Referencesv10
  13. Study sites: 42 to 71v9
  14. Study sites: 33 to 42 Secondary endpoints: details revised at 4 of 22 entries · Eligibility criteria shortened, about 1 wordv8 Show 2 more changesShow less
    • Secondary endpoints: details revised at 4 of 22 entries
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 27 to 33v7
  16. Study sites: 16 to 27v6
  17. Study sites: 14 to 16v5
  18. Study sites: 8 to 14v4
  19. Re-verified, no change to tracked fieldsv3
  20. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 8 · Start date changed from estimate of Jun 7, 2021 to May 25, 2021 · Eligibility criteria expanded, about 10 words · 1 morev2 Show 4 more changesShow less
    • Study sites: 0 to 8
    • Start date changed from estimate of Jun 7, 2021 to May 25, 2021
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (22)

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • 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 participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: \- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), the British Isles Lupus Activity Group-2004 index (BILAG-2004), and the BILAG-BASED Combined Lupus Assessment (BICLA), among others. Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: * After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. * All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. * Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.
Trial Details
NCT Number NCT04895241
Lead Sponsor Biogen
Conditions Lupus Erythematosus, Systemic
Enrollment 548 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov