In short
Clinical trials are investigating XMAB942 in healthy adult volunteers and in adults with ulcerative colitis. The studies aim to evaluate safety and efficacy, including whether XMAB942 can help induce clinical remission in people with moderately to severely active disease.
Key points
- XMAB942 is being studied in a Phase 2 clinical trial for ulcerative colitis, a long-term inflammatory bowel disease. The study starts with healthy adult volunteers and then includes adults with moderately to severely active ulcerative colitis. Researchers are mainly looking at whether XMAB942 can help people reach clinical remission by Week 12. The trial also measures bowel symptoms, rectal bleeding, and endoscopic findings. The trial is authorised and plans to enroll 314 participants.
Trial overview
The clinical trial NCT06619990 is a Phase 2 study of XMAB942 in healthy adult volunteers and then in adults with ulcerative colitis. It is an interventional study, which means participants receive a study treatment and researchers observe the effects.
The study is authorised and plans to enroll 314 people. The brief goal is to evaluate the efficacy of XMAB942 in inducing clinical remission in participants with moderately to severely active ulcerative colitis.
Who can join the study
The study includes healthy adult volunteers in an early stage and then adults with ulcerative colitis. The ulcerative colitis group is described as having moderately to severely active disease.
Ulcerative colitis is described in the trial record as a type of inflammatory bowel disease, meaning a long-term disease that causes inflammation in the colon and rectal lining.
What the study measures
The main endpoint is clinical remission at Week 12. In simple terms, this means the researchers want to see whether symptoms and bowel test results improve enough to meet the study’s remission definition.
Remission is defined by several parts: an MMS of 2 or less, an endoscopic score of 1 or less excluding friability, a rectal bleeding score of 0, and a stool frequency score of 1 or less with at least a 1-point drop from baseline. These measures look at bowel symptoms, bleeding, and the bowel lining seen on camera testing.
Study status and size
The study status is listed as Authorised. The planned enrollment is 314 participants, which means that many people are expected to take part if recruitment goes as planned.
The study uses XMAB942 and a placebo. A placebo is a look-alike treatment that does not contain the active ingredient, so researchers can compare results fairly.
What these results may mean for patients
This trial is focused on whether XMAB942 can help people with moderately to severely active ulcerative colitis reach remission. Because it is a Phase 2 study, it is part of the process of learning more about how well the treatment may work in people with this condition.
The trial does not yet show final proof of benefit, but it is designed to measure important signs of improvement in symptoms and bowel healing.