Phase 3 Crohn's Disease and Colitis Trial, Recruiting NCT07499232 Sponsor: Janssen Research & Development, LLC Condition: Crohn's Disease and Colitis
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Phase 3 Crohn's Disease and Colitis Trial, Recruiting

NCT07499232
Recruiting Phase 3

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 have been diagnosed with Crohn's Disease (a condition causing inflammation in the digestive tract), including a form involving abnormal tunnels between body parts called fistulizing Crohn's Disease, lasting at least 12 weeks, confirmed at some point in the past by imaging, tissue samples, or a camera examination of the gut
  • People whose Crohn's Disease is moderately to severely active, based on a standard disease activity scoring system called the CDAI, with a score between 220 and 450 at the start of the trial
  • People whose gut shows signs of active inflammation and ulcers (open sores) on a camera examination of the bowel done during the screening process, meeting specific scoring thresholds depending on which part of the gut is affected
  • People whose treating doctor considers their disease suitable for the treatment schedules used in this trial
  • People who are able to follow the medication rules set out in the trial protocol

Who may not be able to join:

  • People who have complications of Crohn's Disease such as narrowing of the bowel causing symptoms, short gut syndrome, an active draining opening in the abdomen, significant fistula disease, or other complications that are expected to need surgery within the next year, or that could interfere with measuring treatment response
  • People who currently have, or are suspected to have, a pocket of infection (abscess) in the body
  • People who have an active fistula (an abnormal tunnel between body parts) at the start of the trial and are expected to need surgery for it
  • People who have had any bowel removal surgery within the past 24 weeks, or any other major abdominal or significant surgery within the past 12 weeks before the first dose
  • People who currently have cancer, or who have had cancer at any point in the 5 years before the screening process

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 27 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: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Phone: 844-434-4210

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.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
21 April 2026
Est. completion
15 November 2028

Where this trial is recruiting

🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇳🇱 Netherlands 🇵🇱 Poland 🇸🇰 Slovakia 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Number of Participants with Deep Remission at Week 52

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: 27 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