Crohn's Disease and Colitis Trial, Recruiting (NCT05428345)

Crohn's Disease and Colitis Trial, Recruiting NCT05428345 Sponsor: Takeda Condition: Crohn's Disease and Colitis

Printed from Voxsanity (voxsanity.com.au) — NCT05428345 — 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 moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD), and previous treatments — either standard medications or a type of anti-inflammatory drug called a TNF-α blocker — did not work well enough, stopped working, or caused side effects you could not tolerate.
You have already received at least 2 intravenous (IV, given through a vein) infusions of a medication called vedolizumab and have shown some signs that it is helping your condition.

Who may not be able to join:

You have had an allergic or sensitivity reaction to vedolizumab or its ingredients, such as difficulty breathing, wheezing, hives, flushing, or a fast heartbeat.
You currently have a serious active infection, such as tuberculosis, a viral infection called cytomegalovirus, blood poisoning (sepsis), listeria infection, or certain rare but serious infections affecting the brain or other organs (confirm with trial site).
You have a medical reason why the under-the-skin (subcutaneous) form of vedolizumab would not be safe or suitable for you, based on the official medication guidelines (confirm with trial site).

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 20 July 2026

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Study Director, Takeda

Phone: +1-877-825-3327

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: NCT05428345

Sponsor: Takeda

Phase: Not Applicable

Status: Recruiting

Condition: Crohn's Disease and Colitis

Trial contact: +1-877-825-3327

More information: https://clinicaltrials.gov/study/NCT05428345

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 moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD), and previous treatments — either standard medications or a type of anti-inflammatory drug called a TNF-α blocker — did not work well enough, stopped working, or caused side effects you could not tolerate.
You have already received at least 2 intravenous (IV, given through a vein) infusions of a medication called vedolizumab and have shown some signs that it is helping your condition.

Who may not be able to join:

You have had an allergic or sensitivity reaction to vedolizumab or its ingredients, such as difficulty breathing, wheezing, hives, flushing, or a fast heartbeat.
You currently have a serious active infection, such as tuberculosis, a viral infection called cytomegalovirus, blood poisoning (sepsis), listeria infection, or certain rare but serious infections affecting the brain or other organs (confirm with trial site).
You have a medical reason why the under-the-skin (subcutaneous) form of vedolizumab would not be safe or suitable for you, based on the official medication guidelines (confirm with trial site).

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 20 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

Not Applicable

Sponsor

Takeda

Registry

ClinicalTrials.gov

Start date

25 September 2023

Est. completion

30 November 2027

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

Percentage of Participants With Serious Adverse Events (SAEs); Percentage of Participants With Adverse Drug Reactions (ADRs); Percentage of Participants With Serious Adverse Drug Reactions (SADRs); Percentage of Participants With Adverse Events of Special Interest (AESIs); Percentage of Participants With Unexpected Adverse Events (AEs); Percentage of Participants With Unexpected ADRs

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: 20 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