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 (NCT01951326) enrolled 331 people with Crohn's disease — 166 received an investigational antibiotic combination called RHB-104, and 165 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring "remission" at 26 weeks, meaning whether a participant's Crohn's Disease Activity Index (CDAI) score — a standard tool used to gauge how active someone's Crohn's disease symptoms are — fell below 150 points, which is the threshold considered remission. By the end of the study, 87 participants in each group had completed the full course. The reported data shows that at the 26-week mark (the main measurement point), 61 out of 166 participants in the RHB-104 group met the remission threshold, compared with 37 out of 165 in the placebo group. For the secondary measures, the reported data shows that at week 26, 73 participants in the RHB-104 group and 50 in the placebo group had a CDAI score drop of at least 100 points (called a "response"). At week 16, remission was recorded in 70 RHB-104 participants versus 48 placebo participants, and at week 52, those numbers were 47 versus 32. The reported data also shows that 33 participants on RHB-104 and 21 on placebo maintained remission continuously from week 26 through to week 52. Finally, for the measure of being off steroids for at least three weeks while in remission at week 52, 11 participants in the RHB-104 group and 5 in the placebo group met that count. 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 39199994) ↗
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 are willing and able to sign a consent form to take part in the study.
- You have been diagnosed with Crohn's Disease, confirmed by a scope, scan, or tissue sample, at least 6 months before joining the study.
- Your Crohn's Disease affects the small intestine (ileum) and/or the large intestine (colon).
- Your Crohn's Disease is considered moderately to severely active, based on a standard scoring system used by doctors (confirm with trial site for your specific score).
- You are currently taking at least one of the following medications at a stable dose: an anti-inflammatory called 5-ASA (stable for at least 4 weeks), a steroid (stable for at least 2 weeks), azathioprine, 6-mercaptopurine, or methotrexate (stable for at least 8 weeks), or infliximab or adalimumab (stable for at least 14 weeks).
- Your blood test shows a white blood cell count at or above a certain level, showing your immune system is working adequately (confirm with trial site).
- Blood tests, a stool sample, or a recent scan or scope confirms your Crohn's Disease is currently active.
- You agree to use reliable contraception throughout the study and for at least 6 weeks after your last dose of the study drug, unless you cannot become pregnant for medical or surgical reasons.
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.
- Your Crohn's Disease only affects the mouth, upper digestive tract, or anus.
- You have previously had surgery to remove your entire large intestine or rectum.
- You currently have an active fistula (an abnormal tunnel caused by Crohn's), or had one heal within the last 2 months.
- You have a stoma, ostomy bag, or surgically created internal pouch.
- You have short bowel syndrome (a condition where a large part of the small intestine is missing or removed).
- You are scheduled to have bowel surgery.
- You have had a known blockage or a hole (perforation) in your bowel in the past 6 months.
- Your current Crohn's medication dose was recently changed or stopped within the required stable period before the study start (timeframes vary by medication — confirm with trial site).
- You have been treated with a medication called vedolizumab within the last 120 days, or most other biological therapies within the last 60 days.
- You have ever been treated with the antibiotics rifabutin or clofazimine.
- You have taken oral or injected antibiotics within the 4 weeks before joining the study (skin-applied antibiotics are allowed).
- You have taken probiotic supplements — not including yogurt or yogurt-based products — within the last 4 weeks.
- You are pregnant or currently breastfeeding.
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: Ira N Kalfus, MD, RedHill Biopharma
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 9 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Remission at Week 26
Other options
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.