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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately week 64 for reporting.

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

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