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 (NCT01369329) enrolled 769 people with Crohn's disease — a condition that causes ongoing inflammation in the digestive tract. Participants were divided into three groups: 256 received a placebo (a dummy treatment with no active ingredient), 254 received a fixed dose of ustekinumab (130 mg), and 259 received a weight-based dose of ustekinumab (approximately 6 mg per kilogram of body weight). The trial was measuring how many people showed a meaningful reduction in their Crohn's disease symptom score — tracked using a tool called the Crohn's Disease Activity Index (CDAI), where a higher number means more severe symptoms — by week 6 of treatment. The reported data shows that at week 6, 53 out of 256 people in the placebo group, 84 out of 254 in the 130 mg ustekinumab group, and 84 out of 259 in the weight-based ustekinumab group reached the main target of a significant reduction in their symptom score. For the secondary measurements, the reported data shows that by week 8, the number of participants whose symptom score fell below 150 points (considered a "remission" threshold) was 18 in the placebo group, 39 in the 130 mg group, and 52 in the weight-based group. Also at week 8, those showing a meaningful symptom score reduction numbered 50 (placebo), 82 (130 mg), and 94 (weight-based). Earlier check-ins at week 3 and week 6 also recorded how many people had at least a 70-point drop in their symptom score, with the placebo group recording 67 and 75, the 130 mg group recording 94 and 113, and the weight-based group recording 101 and 109, at weeks 3 and 6 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 42427284) ↗
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 3 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 been diagnosed with Crohn's disease for at least 3 months, affecting your colon, small intestine, or both, confirmed at some point by imaging, tissue testing, or a camera examination of the gut.
- Your Crohn's disease is currently active, based on a specific scoring system that measures disease activity (confirm with trial site for exact score requirements).
- You have previously tried one of these medications for Crohn's disease — infliximab, adalimumab, or certolizumab pegol — at the standard approved dose, and it never worked for you in the first place.
- Or you tried one of those medications and it worked at first but then stopped working over time.
- Or you tried one of those medications but had to stop because you could not tolerate it.
- Your recent blood or lab test results fall within the ranges required by 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.
- You have had any type of bowel surgery within the last 6 months.
- You are pregnant, planning to become pregnant, or (if male) planning to father a child while in the study or within 20 weeks after receiving the study treatment.
- You received infliximab, adalimumab, or certolizumab pegol within 8 weeks before the study drug would first be given to you.
- You have certain serious complications from Crohn's disease that would make it difficult to measure how well the study drug is working (confirm with trial site for specifics).
- You have a history of, or currently have, a long-term or repeatedly occurring infectious disease.
- You have previously received a biologic medication that targets specific parts of the immune system known as IL-12 or IL-23, such as ustekinumab or briakinumab.
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.
Trial contact details on record
Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
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 8 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Number of Participants With Clinical Response at Week 6
Other options
Data last synced from ClinicalTrials.gov: 24 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.