Phase 3 Crohn's Disease and Colitis Trial, Recruiting (NCT07185009)

Phase 3 Crohn's Disease and Colitis Trial, Recruiting NCT07185009 Sponsor: Sanofi Condition: Crohn's Disease and Colitis

Printed from Voxsanity (voxsanity.com.au) — NCT07185009 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Crohns Disease And Colitis

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

People who are between 18 and 80 years old at the start of the study (in some locations, people aged 16 to under 18 may also be eligible if they have reached a certain level of physical development known as Tanner stage 5 — confirm with trial site)
For the Pivotal Maintenance Sub-Study: People who responded well to treatment and completed a specific internal procedure (endoscopy) at the end of a related study called SUNSCAPE-1
For the Open-Label Extension (OLE) Sub-Study: People who have completed either the Pivotal Maintenance Sub-Study or a separate related study called TV48574-IMM-20038

Who may not be able to join:

People whose health conditions or ability to follow the study requirements are considered unsuitable by the doctor running the trial
People who have had a known allergic reaction to the study drug, duvakitug, that the trial doctor considers would make participation unsafe

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 21 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 800-633-1610

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07185009

Sponsor: Sanofi

Phase: Phase 3

Status: Recruiting

Condition: Crohn's Disease and Colitis

Trial contact: 800-633-1610

More information: https://clinicaltrials.gov/study/NCT07185009

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

People who are between 18 and 80 years old at the start of the study (in some locations, people aged 16 to under 18 may also be eligible if they have reached a certain level of physical development known as Tanner stage 5 — confirm with trial site)
For the Pivotal Maintenance Sub-Study: People who responded well to treatment and completed a specific internal procedure (endoscopy) at the end of a related study called SUNSCAPE-1
For the Open-Label Extension (OLE) Sub-Study: People who have completed either the Pivotal Maintenance Sub-Study or a separate related study called TV48574-IMM-20038

Who may not be able to join:

People whose health conditions or ability to follow the study requirements are considered unsuitable by the doctor running the trial
People who have had a known allergic reaction to the study drug, duvakitug, that the trial doctor considers would make participation unsafe

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 21 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 3

Sponsor

Sanofi

Registry

ClinicalTrials.gov

Start date

16 January 2026

Est. completion

21 September 2028

Where this trial is recruiting

🇨🇦 Canada 🇬🇪 Georgia 🇯🇵 Japan 🇱🇹 Lithuania 🇵🇱 Poland 🇷🇸 Serbia 🇺🇦 Ukraine 🇺🇸 United States

Primary endpoints

Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS).

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov