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A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Disease or Ulcerative Colitis (SPECIFI-IBD-LTS)

StatusActive, Not Recruiting
PhasePhase 2
SponsorSanofi
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 22, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Trial sites expanded: 2 → 10 locations
  2. Notable Primary completion moved earlier from May 10, 2030 to Sep 30, 2026 Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Study completion moved earlier from May 10, 2030 to Oct 14, 2026
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 6 of 6 entries
  3. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 2
    • Start date changed from estimate of May 12, 2026 to May 19, 2026
    v4
  4. Notable Start date: Dec 24, 2025 to May 12, 2026v3
  5. Minor Eligibility criteria shortened, about 4 wordsv2
  6. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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LTS19689 is a multinational, multicenter extension study to evaluate the long-term safety, tolerability and efficacy of balinatunfib in participants with Crohn's disease (CD) or ulcerative colitis (UC) who completed the 52-week treatment period (on balinatunfib or placebo) in the parent studies, SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822), respectively. * The primary objective of this study is to assess the long-term safety and tolerability of different doses of balinatunfib in participants with CD or UC, as measured by the number and percentage of participants with CD or UC with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) during the study period. * The study will consist of 2 independent cohorts through the study given the distinct nature of each disease: * CD Cohort: comprised of CD participants enrolled from SPECIFI-CD (DRI18212). * UC Cohort: comprised of UC participants enrolled from SPECIFI-UC (DRI17822). * The study will consist of the following study periods for each cohort: * A Double-Blind (DB) treatment period of up to 104 weeks for eligible participants from the DB maintenance phases of the respective parent studies. * An Open-Label (OL) treatment period of up to 104 weeks for: * Eligible participants from either the DB or OL periods of the parent studies, * Eligible participants who meet escape criteria at any time during the DB period of the LTS19689. * A 2-week follow-up period following the End of Treatment (EOT). The study duration will be up to 107 weeks, with the treatment duration up to 104 weeks.
Trial Details
NCT Number NCT07222189
Lead Sponsor Sanofi
Conditions
(from sponsor)
Colitis Ulcerative, Crohn's Disease
Related terms Colitis, Ulcerative, Crohn Disease
Enrollment 325 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov