Phase 3 Crohn's Disease and Colitis Trial, Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
Treatment Group:
- You completed one of two specific earlier studies (MLN0002-3024 or MLN0002-3025) and your condition improved enough — without needing steroids — by Week 54 of that study (meeting specific score improvements for either ulcerative colitis or Crohn's disease)
- If you are male and sexually active with a female partner who could become pregnant, you agree to use barrier contraception (such as a condom) during the study and for 18 weeks after your last dose, and your partner should also use a highly effective contraceptive method
- If you are female and could become pregnant, and are sexually active with a male partner who has not been sterilized, you agree to use a highly effective method of contraception during the study and for 18 weeks after your last dose
Observation Group (no treatment, just monitoring):
- You received at least one dose of the study drug (vedolizumab) in one of the two earlier studies, but either left that study early or completed it without qualifying for the treatment group of this study
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You currently need or are expected to need major surgery for your bowel condition (such as bowel removal) during the study
- You have developed a new, unstable, or poorly controlled serious health condition affecting the heart, lungs, liver, kidneys, blood, immune system, hormones, nerves, or other areas that could affect the study results or your safety (confirm with trial site)
- You have other serious health conditions that would prevent you from completing the full study
- You are unable to follow all the study requirements and attend all assessments
- You have a known allergy or sensitivity to any of the ingredients in the study drug, vedolizumab
- You are currently pregnant or breastfeeding
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.
Contact this trial
Principal Investigator: Study Director, Takeda
Phone: +1-877-825-3327
Australian sites
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
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Treatment Cohort: Number of Participants With at Least One Adverse Event (AE); Observational Cohort: Number of Participants With Prespecified Safety Events
Can't join this trial?
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.