Phase 2 Crohn's Disease and Colitis Trial, By Invitation
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 who took part in a previous study called SPY123-201 and completed a specific part of it (called Part A), and whose doctor believes they are still benefiting from the treatment.
- People who completed another specific part of the previous study (called Part B).
- People who took part in Part B of the previous study but did not improve enough during the initial treatment phase, or whose condition got worse during the follow-up treatment phase, meeting what the study calls "escape criteria."
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 had to stop treatment early in the previous study (SPY123-201) due to meeting specific stopping rules set out in that study.
- People currently taking certain medications that suppress the immune system, including azathioprine, 6-mercaptopurine, or methotrexate.
- People currently taking other immune-suppressing medications such as tacrolimus, cyclosporine, mycophenolate mofetil, penicillamine, leflunomide, thalidomide, or similar drugs — including treatments using special filtering columns (such as Prosorba columns).
- People currently taking any approved biologic or small molecule therapy for their condition.
- People currently taking any experimental treatment other than the drug used in the previous SPY123-201 study.
- People currently receiving nutrition delivered directly into a vein (total parenteral nutrition).
- People who have developed a new, worsening, or poorly controlled condition affecting organs or body systems — such as the heart, liver, kidneys, lungs, skin, digestive system, nervous system, hormone system, or mental health — or who have an active or suspected infection, immune deficiency, or possible cancer, where the study doctor believes this could affect safety or the reliability of the study results.
- People who have an ongoing infection that requires antibiotic or antiviral treatment (taken by mouth or through a drip) on the first day of the study.
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.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Percentage of participants who experienced an adverse event
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.