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A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 4 → 5 primary endpoints
See other at-risk trials from Roche/Genentech

Record History

  1. Enrollment closed, study ongoing Trial sites reduced: 32 → 26 locationsv40 Show 1 more changeShow less
    • Trial sites reduced: 32 → 26 locations
  2. Primary endpoint(s) modified Trial arms changed: 3 → 4 · Enrollment target: 129 to 119 · Eligibility criteria expanded, about 14 words · 1 morev39 Show 4 more changesShow less
    • Trial arms changed: 3 → 4
    • Enrollment target: 129 to 119
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: 17 to 18

    See this version in full on ClinicalTrials.gov ↗

  3. 2 versions Re-verified since May 22, 2026, no change to tracked fieldsv37-v38
  4. Site details revised at 2 of 32 sitesv36
  5. Re-verified, no change to tracked fieldsv35
Show 33 earlier versionsHide 33 earlier versions
  1. Site details revised at 1 of 32 sitesv34
  2. Site details revised at 1 of 32 sitesv33
  3. Site details revised at 1 of 32 sitesv32
  4. Re-verified, no change to tracked fieldsv31
  5. Primary endpoints: 5 to 4 Enrollment target: 165 to 129 · Primary and study completion dates: Apr 28, 2027 to Jul 8, 2027 · Eligibility criteria shortened, about 7 words · 3 morev30 Show 6 more changesShow less
    • Enrollment target: 165 to 129
    • Primary and study completion dates: Apr 28, 2027 to Jul 8, 2027
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: 18 to 17
    • Site details revised at 1 of 32 sites
    • Study arms: 4 to 3

    See this version in full on ClinicalTrials.gov ↗

  6. Primary endpoints: 6 to 5 Enrollment target: 129 to 165 · Primary and study completion dates: Dec 31, 2026 to Apr 28, 2027 · Interventions: RO7121932 - MAD (Drug), RO7121932 IV - SAD (Drug), RO7121932 SC - SAD (Drug) to RO7121932 IV (Drug), RO7121932 SC (Drug) · 5 morev29 Show 8 more changesShow less
    • Enrollment target: 129 to 165
    • Primary and study completion dates: Dec 31, 2026 to Apr 28, 2027
    • Interventions: RO7121932 - MAD (Drug), RO7121932 IV - SAD (Drug), RO7121932 SC - SAD (Drug) to RO7121932 IV (Drug), RO7121932 SC (Drug)
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 16 to 18
    • Site details revised at 1 of 32 sites
    • Study arms: 3 to 4
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  7. 2 versions Re-verified since Jun 13, 2025, no change to tracked fieldsv27-v28
  8. Study sites: 31 to 32v26
  9. Study sites revised (31)v25 See this version in full on ClinicalTrials.gov ↗
  10. Study sites: 27 to 31v24
  11. Study sites: 26 to 27v23
  12. Study sites: 24 to 26v22
  13. Enrollment target: 63 to 129 Primary and study completion dates: Mar 31, 2025 to Dec 31, 2026 · Primary endpoints: 4 to 6 · Interventions: RO7121932 (Drug) to RO7121932 - MAD (Drug), RO7121932 IV - SAD (Drug), RO7121932 SC - SAD (Drug) · 5 morev21 Show 8 more changesShow less
    • Primary and study completion dates: Mar 31, 2025 to Dec 31, 2026
    • Primary endpoints: 4 to 6
    • Interventions: RO7121932 (Drug) to RO7121932 - MAD (Drug), RO7121932 IV - SAD (Drug), RO7121932 SC - SAD (Drug)
    • Eligibility criteria expanded, about 70 words
    • Secondary endpoints: 12 to 16
    • Site details revised at 6 of 24 sites
    • Study arms: 1 to 3
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  14. Site details revised at 3 of 24 sitesv20
  15. Site details revised at 3 of 24 sitesv19
  16. Site details revised at 1 of 24 sitesv18
  17. Site details revised at 3 of 24 sitesv17
  18. Site details revised at 6 of 24 sitesv16
  19. Primary and study completion dates: Jan 31, 2025 to Mar 31, 2025 Site details revised at 3 of 24 sitesv15 Show 1 more changeShow less
    • Site details revised at 3 of 24 sites
  20. Site details revised at 2 of 24 sitesv14
  21. Site details revised at 2 of 24 sitesv13
  22. Site details revised at 3 of 24 sitesv12
  23. Site details revised at 1 of 24 sitesv11
  24. Site details revised at 3 of 24 sitesv10
  25. Study sites: 23 to 24v9
  26. Study sites: 20 to 23v8
  27. Study title revisedv7 See this version in full on ClinicalTrials.gov ↗
  28. Eligibility criteria shortened, about 23 wordsv6 See this version in full on ClinicalTrials.gov ↗
  29. Site details revised at 2 of 20 sitesv5
  30. Study sites: 19 to 20v4
  31. Study sites: 18 to 19v3
  32. Site details revised at 2 of 18 sitesv2
  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.
The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3), and multiple-ascending SC doses following a single IV dose (Part 4) of RO7121932 in participants with multiple sclerosis (MS). Only Parts 1 and 2 of the study will be conducted in the United States, whereas Parts 1, 2, 3, and 4 will be conducted in all other participating countries outside the United States.
Trial Details
NCT Number NCT05704361
Lead Sponsor Hoffmann-La Roche
Conditions Multiple Sclerosis
Enrollment 119 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov