Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis who failed prior therapy
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- STATUS
- Recruiting
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- participants needed
- 3
Updated on 19 February 2024
Summary
You are being invited to participate in this study because you have been diagnosed with moderate to severe ulcerative colitis (UC) and you are experiencing symptoms such as diarrhea with or without blood, abdominal pain, and may have a sudden or constant feeling that you need to move your bowels and you may have been unable to tolerate or you may have had insufficient response to treatment with medications that help reduce the inflammation associated with your disease, such as infliximab, adalimumab, golimumab, vedolizumab or tofacitinib. This is a research study of a new experimental drug called ABBV-323 being investigated for use in treating subjects with your condition.
Description
Your participation in this study could be up to 69 weeks, including a Screening Period of up to 5 weeks,
a 12-week induction period, and a 40-week maintenance period.
The 12-week induction period is double-blinded, which means that neither you nor your study doctor
will know whether or not you receive the study drug. An induction period is the time from initial
receipt of a medicine and to when a demonstrable response to the medicine is expected to be seen.
The induction period will include approximately 7 study visits to the research center.
If you have improved enough during the initial 12 week double-blind induction period you may be
eligible to go into the open-label maintenance period for ABBV-323, which will last for 40 weeks. Open
label means that you and your study doctor will know which study drug you receive.
If you discontinue or complete all study visits you will enter the 84-day follow up period.
FAQ
Details
| Condition | TBD |
|---|---|
| Age | 18years - 99years |
| Clinical Study Identifier | M15-722 |
| Last Modified on | 19 February 2024 |
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