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)

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NCT07222189 · readout in 1,360 d

Sponsored by Sanofi (industry) · SNY — their whole pipeline →.

Phase

Phase 2

Status

Enrolling by invitation

Study type

Interventional

Design

Non randomized · Quadruple · Treatment

Enrollment

325estimated

Sites

Countries

Bulgaria, Chile

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2026-05-19

actual

When the study began enrolling

Primary completion

2030-05-10

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2030-05-10

estimated

The whole study's end, after follow-up

First posted

2025-10-29

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-05-22

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Colitis Ulcerative
Crohn's Disease

Interventions

Drug: balinatunfib — also filed as SAR441566
Drug: balinatunfib-matching placebo

Primary outcomes

what the primary-completion date above is the date OF

Number of participants with Crohn's Disease with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)

measured 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)

measured Up to End of Study (approximately 106 weeks)

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