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XMAB942

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.

Table of contents

Trial overview

The clinical trial NCT06619990 is a Phase 2 study of XMAB942 in healthy adult volunteers and then in adults with ulcerative colitis.[1] It is an interventional study, which means participants receive a study treatment and researchers observe the effects.[1]

The study is authorised and plans to enroll 314 people.[1] The brief goal is to evaluate the efficacy of XMAB942 in inducing clinical remission in participants with moderately to severely active ulcerative colitis.[1]

Who can join the study

The study includes healthy adult volunteers in an early stage and then adults with ulcerative colitis.[1] The ulcerative colitis group is described as having moderately to severely active disease.[1]

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.[1]

What the study measures

The main endpoint is clinical remission at Week 12.[1] 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.[1]

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.[1] These measures look at bowel symptoms, bleeding, and the bowel lining seen on camera testing.[1]

Study status and size

The study status is listed as Authorised.[1] The planned enrollment is 314 participants, which means that many people are expected to take part if recruitment goes as planned.[1]

The study uses XMAB942 and a placebo.[1] A placebo is a look-alike treatment that does not contain the active ingredient, so researchers can compare results fairly.[1]

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.[1] 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.[1]

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.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06619990 Phase 2 Ulcerative colitis Authorised 314

FAQ

  • What is XMAB942 being studied for? XMAB942 is being studied in clinical trials for ulcerative colitis. The main goal is to see whether it can help people reach clinical remission.
  • Who can take part in the trial? The study includes healthy adult volunteers first, then adults with ulcerative colitis. The ulcerative colitis group has moderately to severely active disease.
  • What phase is the XMAB942 study? This is a Phase 2 study. Phase 2 trials usually look more closely at whether a treatment works and continue to collect safety information.
  • What condition is being studied? The condition is ulcerative colitis, which is a type of inflammatory bowel disease. It causes long-term inflammation in the colon and rectum.
  • What is the main outcome measured in the study? The main outcome is clinical remission at Week 12. This is measured using scores for bowel symptoms, rectal bleeding, and endoscopic findings, which are results from a camera test of the bowel.

Ongoing Clinical Trials on XMAB942

  • A study testing XmAb942 compared to placebo in adults with moderate-to-severe active ulcerative colitis

    Recruiting

    2 1
    Investigated drugs:
    Bulgaria Croatia France Germany Greece Hungary +5

Glossary

  • Ulcerative colitis: A long-term disease that causes swelling and sores in the colon and rectum. It often comes and goes in flares.
  • Inflammatory bowel disease: A group of diseases that cause ongoing inflammation in the digestive tract. Ulcerative colitis is one type of this group.
  • Chronic: A condition that lasts a long time or keeps coming back.
  • Relapsing and remitting: Symptoms get worse for a while, then improve or disappear, and may return later.
  • Gastrointestinal disorder: A disease affecting the stomach or intestines.
  • Clinical trial: A research study in people that tests whether a treatment is safe and whether it works.
  • Phase 2: A stage of testing that looks more closely at how well a treatment works and continues to monitor safety.
  • Clinical remission: A state where signs and symptoms of the disease are very low or absent.
  • Endoscopic findings: Results from a camera test used to look inside the bowel.
  • Rectal bleeding: Bleeding from the rectum, which can be a symptom of ulcerative colitis.
  • Stool frequency: How often a person has bowel movements.
  • Enrollment: The number of people planned to join the study.

References