Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial (NCT05013905) involved 55 people who received a treatment called PRA023, which was being studied in people with Crohn's disease — a condition that causes inflammation in the digestive tract. Of the 55 who started, 53 completed the study and 2 did not finish. The trial was measuring two main things: how the treatment affected participants' bodies (tracked through reported side effects and serious medical events), and whether it produced measurable improvements in their Crohn's disease, as assessed through a camera examination of the bowel (called an endoscopy) and a scoring system based on symptoms. The reported data shows that, out of 55 participants, 43 experienced what are called "treatment-emergent adverse events" — meaning unwanted health events that occurred during the study period. Of those, 8 experienced a "serious adverse event" (a more significant medical event, such as one requiring hospitalisation), and 2 participants stopped taking the treatment due to an adverse event. On the disease-activity side, the reported data shows that 13 out of 55 participants showed endoscopic improvement — meaning their bowel camera score improved by at least half compared to where they started. For secondary (additional) measures, 27 out of 55 participants were reported to have reached clinical remission (a symptom score falling below a set threshold indicating low disease activity), and 9 out of 55 met a combined measure of both bowel camera improvement and symptom score improvement at the same time. These figures describe what was observed and counted in this particular group of trial participants, under the specific conditions of this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Crohn's Disease and Colitis Trial, Completed
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
- You have a confirmed diagnosis of Crohn's disease (CD)
- Your Crohn's disease is considered moderately to severely active, based on a specific activity score and a camera examination of your bowel reviewed by a central medical team
- You either depend on steroids to manage your condition, or you have not responded well to, lost response to, or could not tolerate at least one of the following treatments: steroids, immune-suppressing medications, or certain approved biologic therapies (such as anti-TNF, anti-integrin, or anti-IL-12/23 drugs)
- You are able to give written consent and are willing and able to follow the requirements of the study
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.
- Women who could become pregnant, or men whose female partners could become pregnant, if they are unwilling to use two highly effective forms of contraception throughout the study and for up to 12 weeks after the last dose
- You have been diagnosed with ulcerative colitis or a form of colitis that is unclear or unconfirmed
- Your Crohn's disease only affects certain upper parts of your digestive system (stomach, duodenum, jejunum, or around the anus) without also involving the large or small intestine
- You have a suspected or confirmed pocket of infection (abscess) inside your abdomen or around the anal area at the time of screening
- You currently have or need a stoma bag (an opening in the abdomen to collect waste)
- You have had surgical removal of more than 100 cm of small intestine in total, or removal of more than 2 sections of the large intestine
- You have had bowel surgery within 3 months before the screening visit
- You have current or past evidence of abnormal cell changes (dysplasia) in the colon that have not been fully removed
- In the doctor's opinion, participating in the study would put you at an unacceptable health risk
- Your blood or other laboratory test results do not meet the study's required levels (confirm with trial site)
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
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 3 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Adverse Events; Serious Adverse Events; Adverse Events Leading to Discontinuation; Endoscopic Improvement
Other options
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.