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 (NCT02394028) tested a medicine called etrolizumab in people with Crohn's disease. The trial was run in two main stages — an induction phase (the first 14 weeks) and a maintenance phase (continuing out to around week 66). During the induction phase, participants were divided into several groups across three cohorts, receiving either etrolizumab (at a dose of 105 mg or 210 mg) or a placebo (a dummy treatment with no active ingredient). In total, across all induction cohorts, 1,035 people started the induction phase. Of those who responded to treatment during induction, 487 people then entered the maintenance phase. The trial measured two main things: whether participants reached "clinical remission" (a significant reduction in symptoms such as loose stools and abdominal pain) and whether there was "endoscopic improvement" (a 50% or greater reduction in visible gut inflammation seen via camera). The reported data shows the following for the induction phase at week 14. In the exploratory Cohort 1, clinical remission was reported in 11.9% of placebo participants, 20.0% of those on etrolizumab 105 mg, and 27.3% on etrolizumab 210 mg. Endoscopic improvement in Cohort 1 was reported in 3.4% (placebo), 19.5% (105 mg), and 16.8% (210 mg). In the larger, pivotal Cohort 3, clinical remission was reported in 29.2% of placebo participants, 30.1% on etrolizumab 105 mg, and 33.1% on etrolizumab 210 mg. Endoscopic improvement in Cohort 3 was reported in 21.6% (placebo), 26.2% (105 mg), and 27.4% (210 mg). An open-label Cohort 2 (where all participants knew they were receiving etrolizumab, with no placebo group) reported clinical remission in 29.5% on 105 mg and 29.3% on 210 mg, and endoscopic improvement in 20.8% and 22.2% respectively. For the maintenance phase at week 66, the reported data shows results for two groups: participants who had responded to etrolizumab during induction and were then switched to placebo, and those who continued on etrolizumab 105 mg. Clinical remission at week 66 was reported in 24.0% of those switched to placebo and 35.0% of those who continued on etrolizumab. Endoscopic improvement at week 66 was reported in 12.2% of the placebo group and 23.6% of those continuing on etrolizumab. Results for the small group of placebo-only responders who continued on placebo through maintenance were not reported in the data provided. 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 42436336) ↗
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 moderately to severely active Crohn's Disease, confirmed through symptom scoring, patient-reported symptoms, and a camera examination (endoscopy) of the small intestine and/or colon
- You have tried steroids, immune-suppressing medications, or anti-TNF medications (a type of biologic drug) within the last 5 years, and either could not tolerate them or they did not work well enough for you
- You are using an effective form of birth control as required by the study guidelines (confirm with trial site)
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, or have had, certain other bowel or digestive conditions such as ulcerative colitis, unclassified colitis, abdominal or perianal abscesses, certain colon growths (polyps) that have not been removed, abnormal colon tissue changes, or a significantly shortened bowel
- You are planning to have surgery for your Crohn's Disease
- You have a stoma bag (an ileostomy or colostomy)
- You have recently taken certain specific medications used for bowel inflammation, including natalizumab, vedolizumab, or efalizumab (confirm with trial site for full list)
- You have received the drug ustekinumab within the 14 weeks before joining the study
- You currently have, or have had, chronic hepatitis B or C, HIV, or active or hidden tuberculosis (those who received a BCG vaccine in the past will need to meet specific screening requirements — confirm with trial site)
- You have an infected skin tract with signs of active infection, such as discharge of pus (note: fistulas related to Crohn's Disease alone do not exclude you)
- You have previously been treated with a specific type of medication called anti-adhesion molecules (confirm with trial site for examples)
- You had a serious infection requiring intravenous (IV) antibiotics within the last 8 weeks, or oral antibiotics within the last 4 weeks (note: antibiotics taken as part of Crohn's Disease treatment without a confirmed infection do not exclude you)
- You were admitted to hospital for a non-planned, non-elective reason within the 4 weeks before joining 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.
Trial contact details on record
Principal Investigator: Clinical Trials, Hoffmann-La Roche
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 15 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 14; Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 14; Induction Phase: Cohort 1: Percentage of Participants With Endoscopic Improvement at Week 14; Induction Phase: Cohort 2 and 3: Percentage of Participants With Endoscopic Improvement at Week 14; Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66; Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66
Other options
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.