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

Study acronym: Ametrine-1
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites reduced: 200 → 184 locationsv21
  2. Trial sites reduced: 229 → 200 locationsv20
  3. Study sites: 242 to 229 Primary completion date: Jun 30, 2027 to Jan 30, 2027 · Completion date: Dec 30, 2029 to Jan 30, 2031v19 Show 2 more changesShow less
    • Primary completion date: Jun 30, 2027 to Jan 30, 2027
    • Completion date: Dec 30, 2029 to Jan 30, 2031
  4. Trial status: Recruiting to Active, Not Recruiting Study sites: 312 to 242v18 Show 1 more changeShow less
    • Study sites: 312 to 242
  5. Study sites: 309 to 312v17
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites: 307 to 309v16
  2. Study sites: 303 to 307v15
  3. Study sites: 295 to 303v14
  4. Study sites: 279 to 295v13
  5. Study sites: 268 to 279 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 ↗

  6. Study sites: 245 to 268v11
  7. Study sites: 210 to 245v10
  8. Study sites: 186 to 210v9
  9. Study sites: 156 to 186v8
  10. Study sites: 102 to 156 Eligibility criteria expanded, about 13 words · Secondary endpoints: 23 to 27v7 Show 2 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 23 to 27

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 73 to 102v6
  12. Study sites: 32 to 73v5
  13. Study sites: 9 to 32v4
  14. Re-verified, no change to tracked fieldsv3
  15. Study sites: 6 to 9 Start date changed from estimate of Oct 30, 2024 to Sep 17, 2024v2 Show 1 more changeShow less
    • Start date changed from estimate of Oct 30, 2024 to Sep 17, 2024
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
Trial Details
NCT Number NCT06589986
Lead Sponsor Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical
Conditions Moderately to Severely Active Ulcerative Colitis
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov