Phase 2 Crohn's Disease and Colitis Trial, Recruiting
Who may 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 might be able to join this trial:
- You are between 13 and 28 years old
- You have been diagnosed with Crohn's disease for at least 6 months before joining, confirmed by scans or tissue samples
- Your Crohn's disease is currently active, shown by a disease activity score above 30, plus at least two of the following: raised inflammation levels in your blood, a camera test (endoscopy) showing active disease confirmed by tissue samples, or a CT or MRI scan clearly showing active Crohn's disease in the small bowel
- Your disease has not been well controlled despite trying at least 3 different immune-suppressing medications (such as azathioprine, methotrexate, infliximab, adalimumab, or certolizumab) as well as steroids, or you have had serious side effects from these medications
- Surgery is not a suitable option for you, or surgery could leave you at risk of having too little bowel remaining to absorb food properly
- You have been reviewed and approved as a suitable candidate by the specialist bowel disease team at the trial centre
- You are willing to give your informed consent, take part in additional study visits and tests, and have received thorough counselling about the risks involved
Who may not be able to join:
- You are pregnant, or you are not willing to use reliable contraception during the study (this applies to both women who could become pregnant and men)
- You have serious kidney problems (confirm with trial site)
- You have serious heart problems, such as severe heart failure, a weakened heart, uncontrolled irregular heartbeat, or fluid around the heart causing problems (confirm with trial site)
- Your lungs are not working well enough, specifically if your lung diffusion capacity is below 40% (confirm with trial site)
- You have a psychiatric condition, or are currently misusing alcohol or drugs
- You have, or have recently had, cancer (except for certain common skin cancers)
- You have high blood pressure that remains uncontrolled despite taking at least two blood pressure medications
- You have HIV, HTLV-1 or 2, hepatitis, or any other infection the medical team considers a reason not to participate
- You have another long-term illness causing major organ damage
- You currently have a significant abscess or serious active infection
- You have a perianal fistula (a tunnel near your back passage) that is not draining freely and has not been surgically managed (confirm with trial site)
- You have a history of tuberculosis (TB), are currently at increased risk of TB, or have test results suggesting active TB
- Your chest X-ray shows signs of active infection or a tumour
- You are significantly underweight, with a BMI of 18 or below, or very low protein levels in your blood
- You have a history of not following medical treatment plans as agreed
- You are currently taking part in another clinical trial using an experimental drug, or have done so within the past four weeks
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: David Ziring, MD, Cedars-Sinai Medical Center
Phone: 310-423-7100
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
Primary endpoints
Change in mucosal healing; Change in erythrocyte sedimentation rate (SED rate); Change in fecal calprotectin concentration; Change in C reactive protein (CRP); Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]; Incidence of HSCT Related Complications; Change in clinical measures of sustained remission
Can't join this trial?
Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.