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ABBV-668 for Ulcerative Colitis
Phase 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 56 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests ABBV-668, an experimental drug, on adults with moderate to severe ulcerative colitis. Participants will take capsules regularly over several months. The study will check if the drug is safe and effective by monitoring side effects and disease activity.
Who is the study for?
Adults with moderate to severe Ulcerative Colitis (UC) for at least 3 months, who haven't responded well to standard treatments like aminosalicylates or corticosteroids. They should have an active UC with certain scores on the Adapted Mayo scale and endoscopy results. People with Crohn's disease or limited inflammation only in the rectum can't join.
What is being tested?
The trial is testing ABBV-668 oral capsules' safety and effectiveness for UC treatment. Participants will take these capsules twice daily for 16 weeks, followed by a month of follow-up, while their health is monitored through medical assessments and questionnaires.
What are the potential side effects?
Specific side effects of ABBV-668 are not listed but may include typical drug reactions such as digestive issues, allergic responses, fatigue, headaches, or other symptoms that will be closely monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 56 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 56 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Adverse Events (AEs)
Percentage of Participants Achieving Endoscopic Improvement
Secondary study objectives
Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
Percentage of Participants Achieving Clinical Response per Adapted Mayo Score
Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo score
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ABBV-668Experimental Treatment1 Intervention
Participants will receive ABBV-668 twice daily approximately at same time each day for 52 weeks.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Ulcerative Colitis (UC) include 5-aminosalicylates (5-ASAs), corticosteroids, immunomodulators, and biologic therapies. 5-ASAs, such as mesalamine, reduce inflammation in the colon by inhibiting the production of inflammatory chemicals. Corticosteroids, like prednisone, suppress the immune system to quickly reduce inflammation but are typically used short-term due to side effects.
Immunomodulators, such as azathioprine, alter the immune response to maintain remission. Biologic therapies, including anti-TNF agents like infliximab, target specific proteins involved in the inflammatory process.
These treatments are crucial for UC patients as they help manage symptoms, induce and maintain remission, and prevent complications. ABBV-668, an investigational drug, is being studied for its potential to treat moderate to severe UC, highlighting ongoing efforts to find more effective and safer treatment options.
Novel topical therapies for distal colitis.
Novel topical therapies for distal colitis.
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Who is running the clinical trial?
AbbVieLead Sponsor
1,035 Previous Clinical Trials
523,014 Total Patients Enrolled
31 Trials studying Colitis
21,180 Patients Enrolled for Colitis
ABBVIE INC.Study DirectorAbbVie
456 Previous Clinical Trials
163,663 Total Patients Enrolled
18 Trials studying Colitis
17,222 Patients Enrolled for Colitis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not responded well to certain medications for my condition.I have been diagnosed with Crohn's disease or IBD-U.My inflammation is only in the rectum, confirmed by an endoscopy.I have been diagnosed with ulcerative colitis for over 3 months and have biopsy results to prove it.My ulcerative colitis is active with a moderate to severe score.
Research Study Groups:
This trial has the following groups:- Group 1: ABBV-668
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.