Phase 3 Crohn's Disease and Colitis Trial, Recruiting (NCT07071519)

Phase 3 Crohn's Disease and Colitis Trial, Recruiting NCT07071519 Sponsor: AbbVie Condition: Crohn's Disease and Colitis

Printed from Voxsanity (voxsanity.com.au) — NCT07071519 — 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 have been diagnosed with active ulcerative colitis (a type of inflammatory bowel disease affecting the large intestine) that is currently causing moderate to severe symptoms, confirmed by a camera examination of the bowel during the screening process
You have tried one or more standard treatments for ulcerative colitis (such as anti-inflammatory tablets, steroids, immune-suppressing medicines, or biological medicines) and either they did not work well enough for you, or you were unable to tolerate them
You have had a confirmed diagnosis of ulcerative colitis for at least 3 months before the start of the study, with written records of your diagnosis available

Who may not be able to join:

You have had a major surgical procedure (such as hernia repair, gallbladder removal, or bowel surgery) within the 12 weeks before the study starts, or you are planning to have surgery during the study
You have other significant health conditions, or any other reason your doctor feels would make it unsafe or unsuitable for you to take part in the study

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

Principal Investigator: ABBVIE INC., AbbVie

Phone: 844-663-3742

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: NCT07071519

Sponsor: AbbVie

Phase: Phase 3

Status: Recruiting

Condition: Crohn's Disease and Colitis

Trial contact: 844-663-3742

More information: https://clinicaltrials.gov/study/NCT07071519

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 have been diagnosed with active ulcerative colitis (a type of inflammatory bowel disease affecting the large intestine) that is currently causing moderate to severe symptoms, confirmed by a camera examination of the bowel during the screening process
You have tried one or more standard treatments for ulcerative colitis (such as anti-inflammatory tablets, steroids, immune-suppressing medicines, or biological medicines) and either they did not work well enough for you, or you were unable to tolerate them
You have had a confirmed diagnosis of ulcerative colitis for at least 3 months before the start of the study, with written records of your diagnosis available

Who may not be able to join:

You have had a major surgical procedure (such as hernia repair, gallbladder removal, or bowel surgery) within the 12 weeks before the study starts, or you are planning to have surgery during the study
You have other significant health conditions, or any other reason your doctor feels would make it unsafe or unsuitable for you to take part in the study

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

AbbVie

Registry

ClinicalTrials.gov

Start date

28 July 2025

Est. completion

1 July 2034

Where this trial is recruiting

🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇩🇪 Germany 🇬🇷 Greece 🇮🇹 Italy 🇯🇵 Japan 🇷🇸 Serbia 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax); PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax); PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax); PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax); PK Lead-In Cohort 1: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau); PK Lead-In Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau); Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) Among Week 12 Clinical Responders per mMS; Number...

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