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A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.

Study acronym: SPECIFI-CD
StatusTerminated
PhasePhase 2
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial terminated Sponsor's reason: Business decision.
    • Final enrollment: 105 participants (planned 260)
    • Study completion date changed from estimate of Oct 14, 2026 to Oct 2, 2026
  2. Study sites: 139 to 141
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 5 of 12 entries
  3. Enrollment closed, study ongoing
    • Primary completion date changed from estimate of Jul 21, 2027 to Jul 30, 2026
    • Study completion moved earlier from May 23, 2029 to Oct 14, 2026
    • Site details revised at 139 of 139 sites
    v23
  4. Study sites: 138 to 139v22
  5. Study sites revised (138)v21
  6. Trial sites expanded: 135 → 138 locationsv20
  7. Study sites: 134 to 135v19
  8. Eligibility criteria expanded, about 1 wordv18
  9. Study sites: 133 to 134
    • Eligibility criteria expanded, about 20 words
    v17
  10. Study sites: 123 to 133v16
  11. Study sites: 119 to 123v15
  12. Study sites revised (119)v14
  13. Study sites: 118 to 119
    • Secondary endpoints: details revised at 3 of 12 entries
    v13
  14. Study sites: 115 to 118v12
  15. Study sites: 111 to 115
    • Eligibility criteria expanded, about 4 words
    v11
  16. Study sites: 100 to 111v10
  17. Study sites: 94 to 100v9
  18. Study sites: 76 to 94v8
  19. Study sites: 65 to 76v7
  20. Study sites: 46 to 65v6
  21. Study sites: 19 to 46v5
  22. Study sites: 4 to 19v4
  23. Study sites: 2 to 4v3
  24. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Mar 16, 2025 to Jul 21, 2027
    • Study sites: 0 to 2
    • Study completion date: May 22, 2029 to May 23, 2029
    • Start date changed from estimate of Nov 19, 2024 to Dec 10, 2024
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Sanofi
284 trials monitored
See 12 trials at risk
Crohn's Disease
642 trials monitored
See 34 trials at risk
This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD. This study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment for participants not enrolling in the Long Term Safety (LTS) study. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.
Trial Details
NCT Number NCT06637631
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Crohn's Disease
Related terms Crohn Disease
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov