Phase 4 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:

Part A (initial phase):

• People who were diagnosed with Crohn's disease at least 3 months before the screening visit, confirmed by a camera examination of the gut (endoscopy).
• People whose Crohn's disease is moderately to severely active at the time of screening, based on specific scoring from that endoscopy examination.
• People who have previously tried at least one approved Crohn's disease medication from a group called IL antagonists or TNF antagonists, and either did not respond well enough to it, stopped responding to it over time, or had to stop taking it due to a serious side effect. Note: People who did not respond adequately to more than two different classes of these advanced treatments, or more than one medication within the same class, would not be eligible under this criterion (confirm with trial site).

Part B (continuation phase):

• People who, in the treating doctor's opinion, have shown a benefit from the trial treatment by Week 26.

Who may not be able to join:

• People whose Crohn's disease activity score (CDAI) is above 450, indicating very severe disease activity.
• People currently diagnosed with ulcerative colitis or a related condition called indeterminate colitis.
• People who currently have an abscess (a pocket of infection) in the abdomen.
• People with a known internal tunnel-like passage (fistula) anywhere other than around the back passage, or a known area of dense inflammation called a phlegmon.
• People with a known fistula around the back passage that also has an abscess present.
• People who have had a surgical opening created in the abdomen for waste (ileostomy or colostomy), or who have a serious narrowing of the intestine causing symptoms.
• People who have had large portions of their bowel removed, specifically two or more entire sections of the intestine.
• People with short bowel syndrome, a condition where the intestine cannot absorb enough nutrients.
• People who have any surgery for Crohn's disease planned, except for a specific minor procedure for a back passage fistula without abscess.
• People with a history or current evidence of certain pre-cancerous growths in the colon (adenomatous polyps) that have not been removed.
• People with a history or current evidence of abnormal cell changes in the lining of the colon (mucosal dysplasia).
• People who are unable to undergo a camera examination of the bowel (ileocolonoscopy) for any reason.
• People with any known condition, present from birth or developed later in life, that weakens the immune system.
• People with active or latent (dormant) tuberculosis, regardless of whether they have been treated for it before.
• People who test positive for hepatitis B virus in a specific way, as defined by the trial criteria.
• People who test positive for hepatitis C virus and also have detectable hepatitis C virus in their blood.
• People who have previously received any of a specific list of medications that affect how immune cells move in the body (including vedolizumab, natalizumab, efalizumab, and several others) for the treatment of Crohn's disease.
• People who have a history of, or symptoms that the treating doctor considers consistent with, a serious and rare brain condition called progressive multifocal leukoencephalopathy (PML).

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