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)

Sponsor
Sanofi
Study ID
NCT07222189
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 77 Years
Healthy Volunteers
Not accepted

Interventions

  • balinatunfib — DRUG
    Pharmaceutical form:Tablet -Route of administration:Oral
  • balinatunfib-matching placebo — DRUG
    Pharmaceutical form:Tablet -Route of administration:Oral

Study Details

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.

Key Dates

First listed
Oct 29, 2025
Start date
May 19, 2026
Status verified
May 2026
Primary completion
May 10, 2030
Completion
May 10, 2030

Study Design

Enrollment
325 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CD cohort: balinatunfib dose regimen 1
    Participants will receive balinatunfib dose regimen 1
  • Experimental: CD cohort: balinatunfib dose regimen 2
    Participants will receive balinatunfib dose regimen 2
  • Experimental: CD cohort: balinatunfib dose regimen 3
    Participants will receive balinatunfib dose regimen 3
  • Placebo Comparator: CD cohort: Placebo
    Participants will receive balinatunfib-matching placebo
  • Experimental: UC cohort: balinatunfib dose regimen 1
    Participants will receive balinatunfib dose regimen 1
  • Experimental: UC cohort: balinatunfib dose regimen 2
    Participants will receive balinatunfib dose regimen 2
  • Experimental: UC cohort: balinatunfib dose regimen 3
    Participants will receive balinatunfib dose regimen 3
  • Placebo Comparator: UC cohort: Placebo
    Participants will receive balinatunfib-matching placebo

Primary Outcome Measure

Number of participants with Crohn's Disease with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) [ Time Frame: Up to End of Study (approximately 106 weeks) ]

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