NCT05442567

Who might be able to join this trial:

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 (Treatment Group):

• 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.