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