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A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

Study acronym: Ametrine-2
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Trial sites reduced: 200 → 168 locations · Primary completion moved earlier from Jan 30, 2027 to Oct 29, 2026 · Eligibility criteria expanded, about 16 words · 1 more Show 4 more changesShow less
    • Trial sites reduced: 200 → 168 locations
    • Primary completion moved earlier from Jan 30, 2027 to Oct 29, 2026
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 11 of 17 entries
  2. Site details revised at 4 of 200 sitesv24
  3. Site details revised at 2 of 200 sitesv23
  4. Study sites: 199 to 200v22
  5. Study sites: 198 to 199v21
  6. Primary completion moved earlier from Jun 30, 2027 to Jan 30, 2027 Completion pushed from Dec 30, 2029 to Jan 30, 2031 · Study sites: 196 to 198v20 Show 2 more changesShow less
    • Completion pushed from Dec 30, 2029 to Jan 30, 2031
    • Study sites: 196 to 198
  7. Study sites: 189 to 196v19
  8. Study sites: 178 to 189v18
  9. Study sites: 168 to 178v17
  10. Study sites: 162 to 168v16
  11. Study sites: 154 to 162v15
  12. Study sites: 152 to 154v14
  13. Study sites: 145 to 152v13
  14. Study sites: 137 to 145 Interventions: Placebo (Drug), RO7790121 (Drug) to Afimkibart (Drug), Placebo (Drug) · Study title expanded, about 4 wordsv12 Show 2 more changesShow less
    • Interventions: Placebo (Drug), RO7790121 (Drug) to Afimkibart (Drug), Placebo (Drug)
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 121 to 137v11
  16. Study sites: 112 to 121v10
  17. Study sites: 103 to 112v9
  18. Study sites: 83 to 103v8
  19. Study sites: 39 to 83 Eligibility criteria expanded, about 13 words · Secondary endpoints: 15 to 17v7 Show 2 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 15 to 17

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites: 28 to 39v6
  21. Study sites: 9 to 28 Start date changed from estimate of Dec 31, 2024 to Dec 11, 2024v5 Show 1 more changeShow less
    • Start date changed from estimate of Dec 31, 2024 to Dec 11, 2024
  22. Re-verified, no change to tracked fieldsv4
  23. Start date: Oct 30, 2024 to Dec 31, 2024 Study sites: 4 to 9v3 Show 1 more changeShow less
    • Study sites: 4 to 9
  24. Study sites: 2 to 4 Study title revisedv2 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  25. 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.
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
Trial Details
NCT Number NCT06588855
Lead Sponsor Hoffmann-La Roche
Conditions Moderately to Severely Active Ulcerative Colitis
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov