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A Study of BIIB067 (Tofersen) Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation

Study acronym: ATLAS
StatusActive, Not Recruiting
PhasePhase 3
SponsorBiogen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 29 to 32 Completion date: Aug 7, 2027 to Apr 30, 2028v39 Show 1 more changeShow less
    • Completion date: Aug 7, 2027 to Apr 30, 2028
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 150 to confirmed 158 · Study sites revised (29)v38 Show 2 more changesShow less
    • Enrollment target: estimated 150 to confirmed 158
    • Study sites revised (29)

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 24 of 29 sitesv37
  4. Primary endpoint revised Secondary endpoints: 9 to 8v36 Show 1 more changeShow less
    • Secondary endpoints: 9 to 8

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  5. Study sites revised (29)v35 See this version in full on ClinicalTrials.gov ↗
Show 33 earlier versionsHide 33 earlier versions
  1. Site contacts updated at 1 of 29 sitesv34
  2. Primary completion date: Aug 7, 2026 to Aug 7, 2027 Interventions: BIIB067 (Tofersen) (Drug), Placebo (Drug) to Placebo (Drug), Tofersen (Drug) · Eligibility criteria expanded, about 8 words · Study title revisedv33 Show 3 more changesShow less
    • Interventions: BIIB067 (Tofersen) (Drug), Placebo (Drug) to Placebo (Drug), Tofersen (Drug)
    • Eligibility criteria expanded, about 8 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 4 of 29 sitesv32
  4. Site contacts updated at 1 of 29 sitesv31
  5. Site contacts updated at 1 of 29 sitesv30
  6. Site contacts updated at 2 of 29 sitesv29
  7. Site contacts updated at 1 of 29 sitesv28
  8. Site contacts updated at 1 of 29 sitesv27
  9. Study sites revised (29)v26 See this version in full on ClinicalTrials.gov ↗
  10. Site details revised at 2 of 29 sitesv25
  11. Secondary endpoints: details revised at 1 of 9 entries Study sites revised (29)v24 Show 1 more changeShow less
    • Study sites revised (29)

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  12. Study sites: 30 to 29v23
  13. Study sites revised (30)v22 See this version in full on ClinicalTrials.gov ↗
  14. Study sites revised (30)v21 See this version in full on ClinicalTrials.gov ↗
  15. Site details revised at 1 of 30 sitesv20
  16. Study sites revised (30)v19 See this version in full on ClinicalTrials.gov ↗
  17. Study sites revised (30)v18 See this version in full on ClinicalTrials.gov ↗
  18. Study sites revised (30)v17 See this version in full on ClinicalTrials.gov ↗
  19. Study sites revised (30)v16 See this version in full on ClinicalTrials.gov ↗
  20. Site details revised at 1 of 30 sitesv15
  21. Site details revised at 1 of 30 sitesv14
  22. Study sites revised (30)v13 See this version in full on ClinicalTrials.gov ↗
  23. Study sites revised (30)v12 See this version in full on ClinicalTrials.gov ↗
  24. Study sites revised (30)v11 See this version in full on ClinicalTrials.gov ↗
  25. Re-verified, no change to tracked fieldsv10
  26. Study sites revised (30)v9 See this version in full on ClinicalTrials.gov ↗
  27. Re-verified, no change to tracked fieldsv8
  28. Primary endpoint revised Study sites: 5 to 30 · Eligibility criteria expanded, about 33 words · Secondary endpoints revised (9)v7 Show 3 more changesShow less
    • Study sites: 5 to 30
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints revised (9)

    See this version in full on ClinicalTrials.gov ↗

  29. Study sites: 4 to 5v6
  30. Study sites: 3 to 4v5
  31. Study sites: 2 to 3v4
  32. Study sites revised (2)v3 See this version in full on ClinicalTrials.gov ↗
  33. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of May 7, 2021 to May 17, 2021v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of May 7, 2021 to May 17, 2021
  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
ALS
387 trials monitored
See 18 trials at risk
The primary objective of this study is to evaluate the efficacy of tofersen in presymptomatic adult carriers of a superoxide dismutase 1 (SOD1) mutation with elevated neurofilament (NF). The secondary objectives of this study are to evaluate the safety and tolerability tofersen and to evaluate the effect of tofersen on pharmacodynamics (PD)/treatment response biomarkers when initiated prior to versus at the time of emergence of clinically manifest amyotrophic lateral sclerosis (ALS).
Trial Details
NCT Number NCT04856982
Lead Sponsor Biogen
Conditions Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov