Lutikizumab for Ulcerative Colitis

(Horizon Trial)

Recruiting at 198 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Crohn's disease, Rectum-only disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Optional Long-Term Extension (LTE) Experimental Treatment 2 Interventions

Participants who complete the maintenance period, are willing/able to inject study drug at home, and in whom therapeutic benefit to study drug is confirmed by the investigator may participate in the optional 52-week blinded LTE.

Group II: Maintenance Non-Responders Experimental Treatment 1 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 III: Maintenance Group 2 Experimental Treatment 3 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 IV: Maintenance Group 1 Experimental Treatment 2 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 V: Maintenance Adalimumab Experimental Treatment 2 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 VI: Induction Group 3 Experimental Treatment 2 Interventions

Participants will receive adalimumab per label throughout induction. Lutikizumab placebo will be utilized to maintain the blind.

Group VII: Induction Group 2 Experimental Treatment 2 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 VIII: Induction Group 1 Experimental Treatment 2 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.

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

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois