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Monoclonal Antibodies
Maintenance Group 2 for Ulcerative Colitis
Phase 2
Recruiting
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 week 64
Awards & highlights
Study Summary
"This trial is testing a new drug called lutikizumab for treating ulcerative colitis (UC) by comparing it to an existing drug called adalimumab. Participants will be divided into
Who is the study for?
Adults diagnosed with Ulcerative Colitis for at least 3 months, showing moderate disease activity and not responding well to standard treatments like aminosalicylates or corticosteroids. Participants must have specific scores on medical scales that measure UC severity.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Lutikizumab compared to Adalimumab in treating Ulcerative Colitis. Patients are randomly assigned to different doses of these drugs over an initial 12-week period, followed by maintenance or open-label treatment until Week 52.See study design
What are the potential side effects?
Potential side effects may include reactions at injection sites, increased risk of infections due to immune system suppression, headaches, nausea, and possible infusion-related reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately week 64
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately week 64
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Adverse Events (AEs)
Percentage of Participants who Achieve Endoscopic Improvement
Secondary outcome measures
Percentage of Participants who Achieve Clinical Remission Per Modified Mayo Score (mMS)
Percentage of Participants who Achieve Clinical Response Per mMS
Percentage of Participants who Achieve Endoscopic Remission
Trial Design
7Treatment groups
Experimental Treatment
Group I: Maintenance Non-RespondersExperimental Treatment1 Intervention
Participants who do not respond to study drug at the end of induction period will receive open label SC lutikizumab in the maintenance period.
Group II: Maintenance Group 2Experimental Treatment3 Interventions
Participants who responded to lutikizumab induction group 1 or 2 will be re-randomized. Participants in this group will receive SC lutikizumab throughout the maintenance period. Lutikizumab placebo and adalimumab placebo will be utilized to maintain the blind.
Group III: Maintenance Group 1Experimental Treatment2 Interventions
Participants who responded to lutikizumab induction group 1 or 2 will be re-randomized. Participants in this group will receive SC lutikizumab throughout the maintenance period. Adalimumab placebo will be utilized to maintain the blind.
Group IV: Maintenance AdalimumabExperimental Treatment2 Interventions
Participants who respond to adalimumab induction group 3 will continue to receive adalimumab per label in the maintenance period. Lutikizumab placebo will be utilized to maintain the blind.
Group V: Induction Group 3Experimental Treatment2 Interventions
Participants will receive adalimumab per label throughout induction. Lutikizumab placebo will be utilized to maintain the blind.
Group VI: Induction Group 2Experimental Treatment2 Interventions
Participants will receive Dose 2 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction. Lutikizumab placebo and adalimumab placebo will be utilized to maintain the blind.
Group VII: Induction Group 1Experimental Treatment2 Interventions
Participants will receive Dose 1 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction. Adalimumab placebo will be utilized to maintain the blind.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adalimumab
2013
Completed Phase 4
~6480
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
502,190 Total Patients Enrolled
30 Trials studying Ulcerative Colitis
21,254 Patients Enrolled for Ulcerative Colitis
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,909 Total Patients Enrolled
16 Trials studying Ulcerative Colitis
16,140 Patients Enrolled for Ulcerative Colitis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are prospective participants able to enroll in this research study at the present time?
"The trial is actively seeking participants as indicated on clinicaltrials.gov. It was initially posted on October 4th, 2024, and last revised on March 27th, 2024."
Answered by AI
What is the total number of participants being selected for enrollment in this clinical trial?
"A total of 200 eligible individuals are required to enroll in this research endeavor. Patients meeting the defined inclusion criteria can join from various sites, such as Gastroenterology Associates of Central Georgia, LLC /ID# 258359 based in Macon, Georgia, and Gastroenterology Associates of Western Michigan, PLC also known as West Michigan Clinic /ID# 258493 situated in Wyoming, Michigan."
Answered by AI
Has Induction Group 3 received FDA endorsement?
"According to our assessment at Power, Induction Group 3 has been rated a 2 on the safety scale. This rating is based on being in Phase 2 of the trial where there is limited data supporting safety and no evidence yet for efficacy."
Answered by AI
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