NCT07222189

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)

A Multinational, Multicenter Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Adults With Crohn's Disease or Ulcerative Colitis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 325 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 19 Years – 77 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Colitis Ulcerative
• Crohn's Disease

Interventions

Type	Name	Description
DRUG	balinatunfib	Pharmaceutical form:Tablet -Route of administration:Oral
DRUG	balinatunfib-matching placebo	Pharmaceutical form:Tablet -Route of administration:Oral

Timeline

• Start date: 2026-05-12
• Primary completion: 2030-05-10
• Completion: 2030-05-10
• First posted: 2025-10-29
• Last updated: 2025-12-15

Regulatory

• FDA-regulated drug study