Phase 2 Crohn's Disease and Colitis Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- People aged between 18 and 80 years old
- People who have been diagnosed with Crohn's disease (CD) affecting the small intestine (ileum) or both the small intestine and large intestine, of any type
- People who have been on a stable dose of any Crohn's disease treatment for at least 8 weeks (including biologics, small molecule drugs, or immunosuppressants)
- People whose Crohn's disease activity score (CDAI) is below 450, indicating the disease is not in the most severe range
- People who are willing to have a genetic test to check for a specific gene variant called ZIP8
- People who have not taken steroids in the past 4 weeks
- People who have not taken antibiotics in the past 2 weeks
- People who are willing to give formal consent to participate in the study
- People who are willing to attend all required clinic visits and complete at-home follow-up tasks
- People who are willing to share their most recent endoscopy and imaging results, and, where possible, previously collected tissue samples
- People of childbearing potential who are willing to use highly effective contraception throughout the study and for 30 days after the last dose of the study drug
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have taken GlcNAc (N-acetylglucosamine) or glucosamine supplements in the past 3 months
- People who have an allergy to shellfish
- People with severely active Crohn's disease, defined as a CDAI score above 450
- People whose recent colonoscopy (within 8 weeks of screening) shows a high disease activity score on the Simple Endoscopic Score for Crohn's Disease (SES-CD) — specifically a score of 16 or more overall, or 8 or more for disease limited to the small intestine — if results are available
- People who have taken steroids in the past 4 weeks
- People who have taken antibiotics in the past 2 weeks
- People with serious complications of Crohn's disease — such as a severe bowel blockage, significant fistulas, abscesses inside the abdomen or around the back passage, a bowel perforation, or severe colitis — that may need surgery very soon
- People who have had surgery within the past 12 weeks
- People who recently started or increased a dose of immune-suppressing medication within the past 8 weeks
- People with certain abnormal results on routine blood tests, including very high white blood cell counts, very low haemoglobin, abnormal liver enzyme levels, reduced kidney function, or low iron stores (confirm with trial site for specific values)
- People with a history of Type 1 diabetes, poorly controlled Type 2 diabetes, or Type 2 diabetes managed with insulin
- People with a history of conditions affecting blood vessels or circulation, including peripheral vascular disease, coronary artery disease, stroke, or mini-strokes (transient ischaemic attacks)
- People with a history of cancer
- People who have had an organ transplant
- People with a history of a bleeding disorder
- People with a history of a long-term breathing condition, including asthma
- People with a history of chronic kidney failure
- People with a history of chronic liver disease, including a condition called primary sclerosing cholangitis
- People with a history of seizures or epilepsy
- People who are pregnant, less than 6 months after giving birth, breastfeeding, or currently trying to become pregnant
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: Joanna Melia, MD, Johns Hopkins University
Phone: 410-502-1559
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
Safety and tolerability: Number of Crohn's disease exacerbations
Can't join this trial?
Data last synced from ClinicalTrials.gov: 17 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.