A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

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NCT07184944 · readout in 1,090 d

Sponsored by Sanofi (industry) · SNY — their whole pipeline →. With Teva Branded Pharmaceutical Products R&D LLC.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

751estimated

Sites

Countries

Canada, Georgia, Japan +4

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

2026-01-22

actual

When the study began enrolling

Primary completion

2029-08-13

estimated

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

Study completion

2034-03-20

estimated

The whole study's end, after follow-up

First posted

2025-09-22

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-06-22

actual

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

What it studies

Condition

Crohn's Disease

Interventions

Drug: Duvakitug — also filed as SAR447189
Drug: Placebo

Primary outcomes

what the primary-completion date above is the date OF

Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40

measured Week 40

Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40

measured Week 40

Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission per PRO-2 at Week 40

measured Week 40

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