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

Study acronym: SIBERITE-2
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 2 entries
    • Trial sites expanded: 199 → 203 locations
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 13 of 17 entries
  2. Trial sites expanded: 196 → 199 locationsv22
  3. Trial sites expanded: 187 → 196 locations
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 17 entries
    v21
  4. Trial sites expanded: 178 → 187 locationsv20
  5. Trial sites expanded: 173 → 178 locationsv19
  6. Trial sites expanded: 167 → 173 locationsv18
  7. Trial sites expanded: 162 → 167 locationsv17
  8. Study sites: 155 to 162v16
  9. Study sites: 149 to 155
    • Study completion date: Apr 30, 2029 to Apr 30, 2033
    v15
  10. Study sites: 139 to 149v14
  11. Study sites: 133 to 139v13
  12. Study sites: 123 to 133v12
  13. Study sites: 112 to 123
    • Study completion date: Dec 31, 2028 to Apr 30, 2029
    v11
  14. Study sites: 102 to 112v10
  15. Study sites: 90 to 102v9
  16. Study sites: 80 to 90v8
  17. Study sites: 52 to 80v7
  18. Study sites: 31 to 52
    • 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: 22 to 31
    • Start date changed from estimate of May 9, 2025 to May 12, 2025
    v5
  20. Study sites: 1 to 22
    • Start date: Apr 30, 2025 to May 9, 2025
    v4
  21. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  22. Start date: Mar 31, 2025 to Apr 30, 2025
    • Study completion date: Dec 31, 2033 to Dec 31, 2028
    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 study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Trial Details
NCT Number NCT06819891
Lead Sponsor Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical
Conditions
(from sponsor)		 Moderately to Severely Active Crohns Disease
Enrollment 425 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov