Ulcerative colitis (UC) is a long-lasting bowel disease that causes inflammation of the large intestine (colon). Inflammation is part of the body’s response to protect itself from harm. When this happens in the large intestine, it can lead to many different symptoms including urgent or frequent bowel movements, stomach pain, cramping, and diarrhea. Treatments are available, but they may not work well for everyone, or they may stop working over time. Additional options are needed for people whose UC has not improved from current treatments.
AbbVie’s M21-446 study is evaluating the safety and effectiveness of an investigational oral medicine for adults with moderate to severe UC. This study may be an option for people who:
- Are at least 18 years old
- Have been diagnosed with UC for at least three months
- Have had an inadequate response to, loss of response to, or intolerance to at least one treatment for UC (oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologics or targeted immunomodulators)
There are other requirements to join this study. A study team member will help determine if this study is right for you based on all participation criteria.
Without the help of clinical trial participants, we would not have most of the medical treatments we use today. This study will help us learn more about a potential medicine for UC and may lead to better treatment options for people with UC in the future. By choosing to participate, you are contributing to research that could benefit millions of people around the world. Thank you for considering this important study.
This study is for people with ulcerative colitis (UC). The purpose of this study is to look at the effect of the investigational medicine ABBV-668. It is believed to work by blocking certain proteins involved in the immune response; safety and efficacy have not been established. There is preliminary evidence that suggests ABBV-668 could help with symptoms of moderately to severely active UC.
This study is being conducted at approximately 23 participating research offices worldwide and is expected to enroll approximately 40 subjects.
This study includes a 30-day screening period, 16-week study treatment period, and a 30-day follow up period. During the screening period, the study team will conduct a series of labs and other tests to determine if you meet the requirements to participate in the study.
If you qualify to participate, you will receive ABBV-668 during the 16-week treatment period. This study does not include a placebo (medicine with no active ingredient).
You will have study visits approximately every two weeks for a total of 11 visits. An endoscopy is required at Screening and at Week 8 to evaluate progress and improvement. An endoscopy may also be performed at Week 16 depending on your response to ABBV-668. The investigational medicine and study-related care will be provided at no cost.
Clinical trials, or research studies, help us find new ways to prevent, diagnose, or treat different medical conditions. They evaluate potential treatments to see if they are safe and effective, and how well they work for different types of people.
