Phase 3 Crohn's Disease and Colitis Trial, Recruiting (NCT07184944)

Phase 3 Crohn's Disease and Colitis Trial, Recruiting NCT07184944 Sponsor: Sanofi Condition: Crohn's Disease and Colitis

Printed from Voxsanity (voxsanity.com.au) — NCT07184944 — 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:

You are between 18 and 80 years old (in some locations, people aged 16 to 17 may also be eligible if they have reached full physical maturity — confirm with trial site)
For one part of the trial (called the Pivotal Maintenance Sub-Study): you previously showed improvement in your condition and completed a scope procedure at the end of an earlier related study called STARSCAPE-1
For another part of the trial (called the OLE Sub-Study): you have already completed the Pivotal Maintenance Sub-Study, or you took part in a separate related study called TV48574-IMM-20038

Who may not be able to join:

You have certain health conditions or other reasons that the trial doctor believes would make it unsafe or unsuitable for you to participate
You have had a known allergic reaction to the study drug (duvakitug) that the trial doctor believes makes participation unsuitable for you

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 23 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: NCT07184944

Sponsor: Sanofi

Phase: Phase 3

Status: Recruiting

Condition: Crohn's Disease and Colitis

Trial contact: 800-633-1610

More information: https://clinicaltrials.gov/study/NCT07184944

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:

You are between 18 and 80 years old (in some locations, people aged 16 to 17 may also be eligible if they have reached full physical maturity — confirm with trial site)
For one part of the trial (called the Pivotal Maintenance Sub-Study): you previously showed improvement in your condition and completed a scope procedure at the end of an earlier related study called STARSCAPE-1
For another part of the trial (called the OLE Sub-Study): you have already completed the Pivotal Maintenance Sub-Study, or you took part in a separate related study called TV48574-IMM-20038

Who may not be able to join:

You have certain health conditions or other reasons that the trial doctor believes would make it unsafe or unsuitable for you to participate
You have had a known allergic reaction to the study drug (duvakitug) that the trial doctor believes makes participation unsuitable for you

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 23 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

22 January 2026

Est. completion

13 August 2029

Where this trial is recruiting

🇨🇦 Canada 🇬🇪 Georgia 🇯🇵 Japan Moldova 🇿🇦 South Africa 🇺🇦 Ukraine 🇺🇸 United States

Primary endpoints

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

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: 23 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