Phase 2 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 65 years old at the time of joining the trial
• People who weigh at least 40 kg
• People who have been diagnosed with Crohn's disease for at least approximately one year, confirmed by a camera examination of the bowel (endoscopy), with evidence of active bowel inflammation on endoscopy at least 3 months before or at the screening visit
• People with moderate to severe active Crohn's disease at the time of screening, based on bowel inflammation scores and a symptom scoring system called the CDAI
• People taking steroid medications (such as prednisone at 20 mg per day or less, or budesonide at 9 mg per day or less) may be included, provided the dose has been stable for at least 7 days before receiving the trial treatment
• People whose Crohn's disease has not responded well to at least two different approved treatments — such as TNF-alpha inhibitors, IL-12/23 inhibitors, anti-integrin therapies, or JAK inhibitors — either because the treatment did not work from the start, stopped working over time, or caused unacceptable side effects
• People who do not have an active uncontrolled bacterial, viral, or fungal infection at the time of joining
• People who are able to understand and agree to the study requirements, and are willing and able to attend all required visits and procedures

Who may not be able to join:

• People who have previously had an organ transplant, or a bone marrow, blood stem cell, or cord blood stem cell transplant from another person (note: blood transfusions received more than 3 years before the trial treatment are not automatically disqualifying — confirm with trial site)
• People who have received another experimental treatment or therapy within 28 days before the planned trial treatment (or within 5 half-lives of that treatment, whichever is longer), or who have not yet recovered from side effects of a previous experimental treatment
• People who have received approved Crohn's disease treatments within a required "washout period" before the trial (confirm specific timeframes with trial site)
• People who have been found to have bowel narrowings (strictures), active fistulas (abnormal tunnels in or around the bowel or back passage), or abscesses on imaging or endoscopy within 6 months of screening
• People who test positive for HIV
• People who test positive for active hepatitis B (those who test negative on a more specific hepatitis B blood test may still be considered — confirm with trial site)
• People with detectable hepatitis C virus in their blood
• People with active, recurring, or chronic infections, or untreated latent tuberculosis (TB)
• People currently diagnosed with ulcerative colitis, indeterminate colitis, or Crohn's disease that affects only the colon with no involvement of the small bowel (ileum)
• People with certain known complications of Crohn's disease, including: active diverticulitis, active fistulas or abscesses (abscesses with no pus present may be permitted — confirm with trial site), bowel narrowings that cannot be widened by dilation or that are causing symptoms, severe colitis, toxic megacolon, a permanent stoma (bowel bag) or internal pouch, short bowel syndrome, or any condition likely to require surgery during the study
• People who have had bowel surgery in the 3 months before screening, or who have had more than 2 bowel resections in total (certain reconnection procedures may not count — confirm with trial site)
• People who are pregnant, breastfeeding, or planning to become pregnant during the 12-month study period; all participants (male and female) must agree to use a highly effective form of contraception
• People whose screening blood tests show certain abnormal results, including: liver enzyme levels more than 3 times the normal upper limit, low white blood cell count, reduced kidney function below a certain level, low haemoglobin (below 8 g/dL), high bilirubin, low platelet count, or low levels of certain types of white blood cells (neutrophils or lymphocytes)
• People with a significant history of kidney, liver, lung, or heart problems, or who are on treatment to support heart function
• People with any serious illness, uncontrolled ongoing illness, psychiatric condition, active infection, or other medical or laboratory finding that the trial doctor believes could put the person at increased risk, affect their ability to give informed consent and participate, or make it difficult to interpret the trial results

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