A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

Study acronym: SIBERITE-1
StatusRecruiting
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 374 to 375
  2. Primary endpoints: details revised at 1 of 2 entries
    • Study sites: 373 to 374
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 20 of 28 entries
  3. Study sites: 372 to 373v21
  4. Secondary endpoints: details revised at 3 of 28 entries
    • Site details revised at 1 of 372 sites
    v20
  5. Trial sites expanded: 364 → 372 locationsv19
  6. Study sites: 362 to 364v18
  7. Trial sites expanded: 355 → 362 locationsv17
  8. Trial sites expanded: 344 → 355 locationsv16
  9. Study sites: 330 to 344v15
  10. Study sites: 320 to 330v14
  11. Study sites: 305 to 320v13
  12. Study sites: 281 to 305v12
  13. Study sites: 249 to 281v11
  14. Study sites: 212 to 249v10
  15. Study sites: 181 to 212v9
  16. Study sites: 157 to 181v8
  17. Study sites: 114 to 157v7
  18. Study sites: 82 to 114
    • Interventions: Placebo (Drug), RO7790121 (Drug) to Afimkibart (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 1 word
    • Study title expanded, about 1 word
    v6
  19. Study sites: 46 to 82v5
  20. Study sites: 29 to 46v4
  21. Study sites: 21 to 29
    • Start date changed from estimate of Mar 10, 2025 to Mar 17, 2025
    v3
  22. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 21
    • Start date: Feb 28, 2025 to Mar 10, 2025
    v2
  23. Study First Submitted
  • 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 induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Trial Details
NCT Number NCT06819878
Lead Sponsor Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical
Conditions
(from sponsor)		 Moderately to Severely Active Crohns Disease
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov