Trial results

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According to the results reported on ClinicalTrials.gov, this trial (NCT02403323) involved people with Crohn's disease — a condition causing ongoing inflammation in the digestive tract. A total of 751 participants took part across two parts of the study. Part 1 was an open-label extension period, meaning all participants received the study drug, etrolizumab, and knew they were receiving it. Part 2 was a safety monitoring period that did not involve the study drug. The trial was measuring how many participants reached certain disease score thresholds at regular intervals, how many showed improvement on an internal camera examination of the gut (called an endoscopy), and how many participants experienced unwanted medical events (called adverse events) while on the drug. The reported data shows that, looking at two different scoring systems used to assess Crohn's disease activity, the numbers of participants recorded as reaching the remission threshold (low disease activity scores) varied across the check-in points over roughly two years. For example, using one scoring system (CDAI, a composite score based on eight factors), the reported numbers of participants at the remission threshold ranged from 230 at the first check-in down to 73 at the last check-in. Using a second scoring system based on stool frequency and abdominal pain, the numbers ranged from 200 down to 71 across the same time points. At a single endoscopy check point (week 108), 147 participants were reported to have shown at least a 50% reduction in their internal gut inflammation score compared to their starting point. The reported data also shows that 624 out of 751 participants experienced at least one adverse event (an unwanted medical occurrence recorded during the study) during Part 1. Of those, 206 participants experienced a serious adverse event — defined as one that was life-threatening, required hospitalisation, or caused significant disability. Regarding infections specifically, 366 participants were reported to have had at least one infection-related adverse event, with the majority recorded as mild or moderate in severity; 5 participants had a life-threatening infection-related event and 1 participant died from an infection-related adverse event. It is important to note that these numbers describe events that were recorded during the study period and do not, on their own, establish a cause-and-effect relationship with the study drug. 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 32445184) ↗

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.