Phase 3 Crohn's Disease and Colitis Trial, Recruiting

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 are 18 years old or older and have been diagnosed with Crohn's disease
• Your Crohn's disease is moderately to severely active, based on a specific activity score (CDAI between 250 and 450), and ulcers have been found in your small or large intestine during a camera examination (endoscopy)
• You have either not responded to, stopped responding to, or had unacceptable side effects from one or more of the following treatments: steroids, azathioprine, mercaptopurine, thioguanine, methotrexate, adalimumab, vedolizumab, or ustekinumab — or your doctor believes you need to start strong treatment straight away
• You are able to understand and follow the study's requirements, in the opinion of the study doctor
• You are willing to sign a consent form before any study procedures begin
• You are male, or a female who is not pregnant or breastfeeding, and you do not wish to become pregnant in the next 26 weeks

Who may not be able to join:

• Your doctor believes you urgently need surgery
• You have short bowel syndrome, a stoma (ostomy bag), or a narrowing of the bowel that is causing symptoms but is not due to inflammation
• You have previously received infliximab (IFX) treatment, either by drip or injection
• You have previously had serious side effects or could not tolerate both thiopurines (e.g. azathioprine) and methotrexate
• You have taken adalimumab, vedolizumab, or ustekinumab within the last 30 days
• You never responded to adalimumab in the first place, or had serious side effects related to that type of medication (confirm with trial site)
• A stool test taken within the last 2 weeks has found a bowel infection (such as Salmonella, Shigella, Yersinia, Campylobacter, or C. difficile)
• You are currently taking part in another clinical trial involving a treatment or intervention
• You have been diagnosed with Ulcerative Colitis or an unclassified form of inflammatory bowel disease
• You currently have an abscess (a pocket of infection) in your abdomen or around your back passage that has not been drained
• You have a history of bowel cancer or pre-cancerous changes in the bowel, unless a single non-cancerous polyp was found and fully removed
• You have active or latent (hidden) tuberculosis that has not been properly treated according to national guidelines
• You have moderate to severe heart failure (confirm with trial site)
• You have a history of a nerve-damaging condition such as multiple sclerosis (demyelinating disease)
• You have received a live vaccine (such as MMR or yellow fever) within the last 4 weeks
• You have an ongoing serious infection, including HIV, hepatitis B, or hepatitis C (cold sores or HPV do not apply)
• You have been diagnosed with cancer in the last 5 years, except for a common type of non-serious skin cancer (non-melanoma)
• You are male and a blood test shows you have never been exposed to Epstein-Barr virus (the virus that causes glandular fever)
• You have a history of alcohol or drug misuse that the study doctor believes would affect your ability to take part
• You have mental health difficulties that the study doctor believes would affect your ability to take part
• You are unable to attend all of the required study visits
• You have a history of not following the rules of clinical studies in the past
• You have a medical reason why you cannot safely have an endoscopy (camera examination)
• You have taken part in another drug trial or received an experimental treatment within the last 30 days (or longer, depending on the drug)
• You are pregnant, breastfeeding, or wish to become pregnant in the next 26 weeks

Important: Always verify eligibility with the trial site directly before applying.