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)

NCT07222189 · tracked via the Priya Life Science Italy tracker

Sponsor

Sanofi

Phase

Phase 2

Started

2026-05-19

Last updated

2026-09-22

Condition(s) studied

Colitis UlcerativeCrohn's Disease

Investigational drug(s) / intervention(s)

balinatunfib →balinatunfib-matching placebo

balinatunfib: Pharmaceutical form:Tablet -Route of administration:Oral

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

Study 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.

Eligibility

Sex

ALL

Min age

19 Years

Max age

77 Years

Healthy volunteers

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participants with Crohn's Disease (CD) or ulcerative colitis (UC) who completed treatment at Week 52 of the SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822) studies, respectively: * Participants with CD 1. who complete double-blinded treatment at Week 52 of SPECIFI-CD (DRI18212) study; 2. who complete open label treatment and achieve the appropriate outcomes at Week 52 of SPECIFI-CD (DRI18212) study. OR * Participants with UC 1. who complete double-blinded treatment at Week 52 of SPECIFI-UC (DRI17822) study; 2. who complete open label treatment and achieve the appropriate outcomes at Week 52 of the SPECIFI-UC (DRI17822) study. * Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding Exclusion Criteria: * Participants with CD who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-CD (DRI18212) clinical trial protocol. * Participants with UC who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-UC (DRI17822) clinical trial protocol. * Participants who developed a new medical condition or a change in status of an established medical condition which (per Investigator's medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation. * Participants who permanently discontinued IMP during the parent study or temporarily discontinued IMP for more than 14 consecutive calendar days by the time of Day 1 of LTS19689. * Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to balinatunfib, which in the opinion of the Investigator could indicate that continued treatment with balinatunfib may present an unreasonable risk for the participant. * Participants who in the parent study had documented nonadherence to IMP or to standard therapies for CD or UC, or who used a prohibited medication concomitant with IMP or during a temporary IMP discontinuation period. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcome measure(s)

Number of participants with Crohn's Disease with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) — Up to End of Study (approximately 106 weeks)
Number of participants with ulcerative colitis with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) — Up to End of Study (approximately 106 weeks)

Trial sites (10)

Facility	City	Region
Texas Digestive Disease Consultants - Southlake- Site Number : 8400005	Southlake	Texas
Investigational Site Number : 0320001	Buenos Aires	Argentina
Investigational Site Number : 1000001	Gorna Oryahovitsa	Bulgaria
Investigational Site Number : 1520016	Santiago	Reg Metropolitana de Santiago
Investigational Site Number : 1520010	Santiago	Reg Metropolitana de Santiago
Investigational Site Number : 1520012	Santiago	Reg Metropolitana de Santiago
Investigational Site Number : 1560002	Guangzhou	China
Investigational Site Number : 1560032	Shanghai	China
Investigational Site Number : 2030001	Olomouc	Czechia
Investigational Site Number : 3800002	Milan	Milano

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07222189 on ClinicalTrials.gov ↗ ← All trials in Italy