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NCT07185009 · ClinicalTrials.gov registry record · Phase 3

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 study of Ulcerative Colitis, sponsored by Sanofi.

Recruiting
Registry status
Phase 3
Development phase
671
Enrollment target
5
Study locations

NCT07185009 is a Phase 3 study of Ulcerative Colitis that is actively recruiting participants, run by Sanofi. The registered enrollment target is 671 participants, below the 2,052-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (67% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT07185009, a Phase 3 study of Ulcerative Colitis, is actively recruiting participants, sponsored by Sanofi.

RECRUITING
Registry status
Phase 3
Development phase
671 participants
Enrollment target
5
Study locations

Study Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visit will be up to 32: * 21 visits in the Pivotal Maintenance Sub-Study. * 11 visits in the OLE Sub-Study.

Conditions Studied

Ulcerative Colitis

Interventions

  • DRUG Placebo
  • DRUG Duvakitug

Study Locations (5)

Florida

  • Royal Palm Clinical Research - Site Number: 8400065 - Fort Myers
  • Clinical Research of Osceola - Site Number: 8400013 - Kissimmee

Louisiana

  • Delta Research Partners - Site Number: 8400087 - Monroe

Missouri

  • BVL Clinical Research - Site Number: 8400005 - Liberty

Texas

  • Tyler Research Institute, LLC - Site Number: 8400095 - Tyler

Trial Details

FieldValue
Enrollment Target 671 participants
Start Date 2026-01-16
Est. Completion 2033-04-28
Phase Phase 3

Sponsor

Sanofi

713 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07185009

The ClinicalTrials.gov registry entry for NCT07185009 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 671 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,052-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (67% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT07185009 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Florida, Louisiana, Missouri.

Frequently Asked Questions

What is clinical trial NCT07185009 about?

NCT07185009 is a clinical study titled "A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis". This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 286 weeks including: * ...

What is the current status of trial NCT07185009?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 671 participants. The study started on 2026-01-16. Estimated completion is 2033-04-28.

What conditions does trial NCT07185009 study?

This clinical trial studies the following conditions: Ulcerative Colitis.

What interventions are being tested in trial NCT07185009?

The interventions under investigation include: Placebo (DRUG), Duvakitug (DRUG).

Who is sponsoring clinical trial NCT07185009?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07185009 being conducted?

This trial has 5 study locations across Florida, Louisiana, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.