200 Participants Needed

Lutikizumab for Ulcerative Colitis

(Horizon Trial)

Recruiting at 202 trial locations
AC
Overseen ByABBVIE CALL CENTER
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AbbVie
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). The purpose of this study is to assess how safe and effective lutikizumab is in adult participants with moderate to severe UC and how lutikizumab compares to adalimumab in the treatment of UC. Adverse events and changes in disease activity will be assessed.Lutikizumab is an investigational product being developed for the treatment of moderate to severe UC. Participants are placed in groups called treatment arms. Each group receives a different treatment. In the Induction Period, participants will be randomized into 1 of 3 arms receiving lutikizumab Dose 1, lutikizumab Dose 2, or adalimumab. In the Maintenance Period, participants who responded to lutikizumab will be randomized into 1 of 2 arms of lutikizumab maintenance and participants who responded to adalimumab will continue to receive adalimumab. All participants who did not achieve clinical response per modified Mayo Score at the end of the Induction period will receive open label lutikizumab. Around 200 adult participants with UC will be enrolled at approximately 280 sites worldwide.During the 12 week Induction Period, participants will be randomized to receive intravenous (IV) and subcutaneous (SC) lutikizumab or SC adalimumab. At the 12 week mark, participants who are on lutikizumab who have responded to treatment will be re-randomized to receive SC lutikizumab at different intervals until Week 52. Participants who are on adalimumab who are responding to treatment will continue to receive adalimumab. Participants who do not respond to treatment will receive open-label SC lutikizumab. Participants who complete the Week 52 visit and in whom therapeutic benefit to study drug is confirmed by the investigator may roll over into an optional, blinded 52-week long-term extension (LTE).There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants should have had an inadequate response or intolerance to certain medications like oral aminosalicylates, corticosteroids, or immunomodulators, which might imply changes to your current treatment. It's best to discuss this with the trial coordinators.

Who Is on the Research Team?

AI

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My ulcerative colitis is active with a moderate to severe score.
My condition didn't improve with certain medications like steroids or immunomodulators.
I have been diagnosed with Ulcerative Colitis for over 3 months and have biopsy results.

Exclusion Criteria

My inflammation is only in the rectum, confirmed by an endoscopy.
I have been treated with adalimumab or its equivalents before.
I have been diagnosed with Crohn's Disease or an unspecified inflammatory bowel condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants are randomized to receive IV and SC lutikizumab or SC adalimumab for 12 weeks

12 weeks
Regular visits at a hospital or clinic

Maintenance

Participants who responded to induction treatment continue with SC lutikizumab or adalimumab until Week 52

40 weeks
Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Optional Long-Term Extension (LTE)

Participants may roll over into an optional, blinded 52-week long-term extension if therapeutic benefit is confirmed

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lutikizumab
Trial Overview 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.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Group I: Optional Long-Term Extension (LTE)Experimental Treatment2 Interventions
Group II: Maintenance Non-RespondersExperimental Treatment1 Intervention
Group III: Maintenance Group 2Experimental Treatment3 Interventions
Group IV: Maintenance Group 1Experimental Treatment2 Interventions
Group V: Maintenance AdalimumabExperimental Treatment2 Interventions
Group VI: Induction Group 3Experimental Treatment2 Interventions
Group VII: Induction Group 2Experimental Treatment2 Interventions
Group VIII: Induction Group 1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security