Table of contents
Trial overview
The clinical trial of Abbv-668 studied adults with moderate to severe ulcerative colitis.[1] The study aimed to evaluate both safety and efficacy, which means it looked at whether the treatment could help and whether it could be used safely in the study setting.[1]
Who participated
The trial enrolled adult subjects with moderately to severely active ulcerative colitis.[1] This means the study was not for healthy volunteers or for children, but for adults living with active disease.[1]
Study design and phase
This was a Phase 2 interventional study.[1] Phase 2 studies are used to learn more about whether a treatment may work in the target disease and to continue safety checks.[1]
The study was also single-arm and open-label.[1] Single-arm means there was only one treatment group, and open-label means the treatment was known to the study team and the participants.[1]
What was measured
The main endpoint was endoscopic improvement at Week 8.[1] Endoscopic improvement means the colon looked better on a camera test, using a Mayo Endoscopic Subscore (ESS) of 0 or 1.[1]
The Mayo ESS is a score used to describe how much inflammation is seen during endoscopy in ulcerative colitis.[1] A score of 0 or 1 shows little or no visible inflammation compared with worse scores.[1]
Trial status and size
The trial was completed and enrolled 60 participants.[1] The study title and summary show that Abbv-668 was given by oral use in this trial.[1]
