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Monoclonal Antibodies
Lutikizumab for Ulcerative Colitis (Horizon Trial)
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
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.
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.
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
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 who Achieve Endoscopic Improvement
Secondary study objectives
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
~7950
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,040 Previous Clinical Trials
523,379 Total Patients Enrolled
31 Trials studying Colitis
21,010 Patients Enrolled for Colitis
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
164,164 Total Patients Enrolled
18 Trials studying Colitis
17,052 Patients Enrolled for Colitis