A single arm, open-label study to evaluate the efficacy and safety of ABBV-668
Published: 09/28/2022
General Information:
To characterize the safety and efficacy of ABBV-668 500mg by mouth (PO) twice a day (BID) as treatment in adult patients with moderately to severely active UC.
Eligibility:
Key eligibility criteria include:
1. Adult male or female, at least 18 years old at time of the Baseline visit.
2. Diagnosis of UC for at least 90 days prior to Baseline.
3. Patient meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review).
4. Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunosuppressants and/or biologics or targeted immunomodulators.
5. No current diagnosis of Crohn’s disease (CD) or inflammatory bowel disease-unclassified.
6. No extent of inflammatory disease limited to the rectum.
Study Details:
Study description/explanation of participation:
If you take part, you will be in the M21-446 study, which contains a 30-day screening period, 16-week treatment period, and a 30-day follow up period from the last dose of study drug. All patients enrolled into the study will receive active study drug.
Description of treament or intervention (mechanism of action):
ABBV-668 is an oral capsule that will be taken twice daily.
Patient participation requirements:
· Attend all study visits
· Tell the study doctor if you are feeling bad or worse than before
· Tell the study doctor if you have any changes in any medications during the study
· Follow the directions of the study doctor and research team
· Refrain from participation in other research studies while you are a participant in this study
· Fill out the electronic questionnaires and electronic diary completely and honestly. You will be required to bring the electronic diary to the study doctor’s office at each visit.
Possible risks and side effects:
ABBV-668 is being investigated for use in ulcerative colitis. It is not approved in any countries and safety and efficacy have not been established. The clinical trial investigator will review all of the known potential side effects with you to help you determine if you would like to participate in the trial.