Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT06233461 Sponsor: Takeda Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT06233461
Recruiting Phase 2 🇦🇺 Australian site

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 aged 18 to 75 years old (or 19 and older in South Korea) who have been diagnosed with Crohn's disease for at least 30 days
  • People whose Crohn's disease is considered moderately to severely active, based on specific medical scoring tests
  • People whose previous treatments for Crohn's disease did not work well enough, stopped working over time, or caused side effects they could not tolerate — this includes standard medications, biological therapies, or other advanced treatments

Who may not be able to join:

  • People diagnosed with certain other types of bowel or colon conditions, such as ulcerative colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, indeterminate colitis, or colitis related to diverticular disease
  • People who have Crohn's disease complications that are likely to require surgery during the study period
  • People who currently have a stoma (an opening on the abdomen connected to the digestive system)
  • People whose Crohn's disease has not responded to three or more different classes of advanced treatments

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 22 July 2026
Phase 2: approximately ~30% 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: Study Director, Takeda

Phone: +1-877-825-3327

Australian sites

Concord Repatriation General Hospital, Sydney, New South Wales
297676111
Mater Cancer Care Centre-Mater Health Services, South Brisbane, Queensland
731638196
Flinders Medical Centre, Bedford Park, South Australia
882044964
The Queen Elizabeth Hospital, Woodville, South Australia
882225827
Western Health/Footscray Hospital, Melbourne, Victoria
Harry Perkins Medical Research Institute Fiona Stanley Hospital, Murdoch, Western Australia
Royal Perth Hospital, Perth, Western Australia
Northern Hospital Epping, Epping,
Sir Charles Gairdner Hospital (SCGH) - Comprehensive Cancer Centre, Nedlands,

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
5 March 2024
Est. completion
18 September 2026

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇷🇴 Romania 🇸🇰 Slovakia 🇰🇷 South Korea 🇨🇭 Switzerland 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

9 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12

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: 22 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