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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 week 8
Awards & highlights
Study Summary
This trial will assess the safety and efficacy of ABBV-668 in the treatment of adults with UC.
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.Check my eligibility
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.See study design
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 ~ week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Achieving Endoscopic Improvement
Secondary outcome measures
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 moreTrial 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 16 weeks.
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Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
502,350 Total Patients Enrolled
30 Trials studying Ulcerative Colitis
21,414 Patients Enrolled for Ulcerative Colitis
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,069 Total Patients Enrolled
16 Trials studying Ulcerative Colitis
16,300 Patients Enrolled for Ulcerative 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment ongoing for this trial?
"The trial, initially posted on November 1st 2022, is no longer accepting participants according to the information provided through clinicaltrials.gov. Nevertheless, 407 other studies are currently recruiting subjects for their respective medical trials."
Answered by AI
Has ABBV-668 earned regulatory clearance from the FDA?
"Our team at Power assigned ABBV-668 a safety rating of 2 since this is only in Phase 2, so there's proof that it won't be harmful but no evidence yet for its effectiveness."
Answered by AI
What is the number of institutes assessing this trial?
"The list of participating sites includes NYU Langone Long Island Clinical Research Associates (ID# 250075) in Lake Success, New york; Gastroenterology Associates of Central Georgia, LLC (ID# 249278) based out of Macon, Georgia; and Ctr for Advanced Gastroenterol (ID# 249226), located in Maitland, Florida. There are also 13 additional locations that are recruiting participants."
Answered by AI
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