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)

Sanofi

Status and phase: Begins enrollment in 3 months; Phase 2

Conditions: Colitis Ulcerative; Crohn's Disease

Treatments: Drug: balinatunfib-matching placebo; Drug: balinatunfib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07222189

LTS19689

U1111-1321-1765 (Registry Identifier)

2025-522511-42 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 325 estimated patients

Sex: All

Ages: 19 to 77 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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325 participants in 8 patient groups, including a placebo group

CD cohort: balinatunfib dose regimen 1

Experimental group

Description:

Participants will receive balinatunfib dose regimen 1

Treatment:

Drug: balinatunfib

CD cohort: balinatunfib dose regimen 2

Experimental group

Description:

Participants will receive balinatunfib dose regimen 2

Treatment:

Drug: balinatunfib

CD cohort: balinatunfib dose regimen 3

Experimental group

Description:

Participants will receive balinatunfib dose regimen 3

Treatment:

Drug: balinatunfib

CD cohort: Placebo

Placebo Comparator group

Description:

Participants will receive balinatunfib-matching placebo

Treatment:

Drug: balinatunfib-matching placebo

UC cohort: balinatunfib dose regimen 1

Experimental group

Description:

Participants will receive balinatunfib dose regimen 1

Treatment:

Drug: balinatunfib

UC cohort: balinatunfib dose regimen 2

Experimental group

Description:

Participants will receive balinatunfib dose regimen 2

Treatment:

Drug: balinatunfib

UC cohort: balinatunfib dose regimen 3

Experimental group

Description:

Participants will receive balinatunfib dose regimen 3

Treatment:

Drug: balinatunfib

UC cohort: Placebo

Placebo Comparator group

Description:

Participants will receive balinatunfib-matching placebo

Treatment:

Drug: balinatunfib-matching placebo