Lutikizumab for Ulcerative Colitis

(Horizon Trial)

Not currently recruiting at 244 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines lutikizumab, a potential new treatment for moderate to severe ulcerative colitis (UC), a condition that causes inflammation and bleeding in the colon and rectum. The trial compares the safety and effectiveness of lutikizumab to adalimumab, another UC treatment. Participants receive different doses of lutikizumab or adalimumab, and researchers monitor their responses through medical check-ups and questionnaires. Individuals with UC for at least 90 days who haven't responded well to other treatments might be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lutikizumab is generally safe. In one study, serious side effects occurred in only 5.3% of participants, indicating that most did not experience major issues.

Adalimumab, the other treatment in this trial, is already approved for various conditions and has a well-known safety record. It is widely used, and doctors understand its effects well.

Both treatments are being tested for safety in people with ulcerative colitis, a condition that causes gut inflammation. For those considering joining the trial, data suggests that lutikizumab has been safe in other studies, and adalimumab has a well-documented safety history. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about lutikizumab for ulcerative colitis because it targets the interleukin-1 pathway, a novel approach compared to the usual TNF inhibitors like adalimumab and infliximab. This new mechanism could potentially offer benefits to patients who do not respond well to existing treatments. Additionally, lutikizumab is initially given intravenously and then via subcutaneous injections, which might offer more flexibility and convenience in administration. These unique features make lutikizumab a promising option in the quest for more effective ulcerative colitis treatments.

What evidence suggests that this trial's treatments could be effective for ulcerative colitis?

Research shows that lutikizumab may help treat ulcerative colitis (UC). In this trial, participants will receive different treatments to evaluate their effectiveness. Some participants will receive lutikizumab, which earlier studies found more effective at reducing visible inflammation in the colon than adalimumab, a common UC treatment. This suggests that lutikizumab might help lessen UC symptoms and inflammation. However, while these findings are encouraging, they are not yet final. More research is needed to fully understand its effectiveness and safety for UC. ^{2 4 6 7 8}

Who Is on the Research Team?

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?

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 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 SC lutikizumab in the maintenance period.

Group III: Maintenance Group 2 Experimental Treatment 1 Intervention

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.

Group IV: Maintenance Group 1 Experimental Treatment 1 Intervention

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.

Group V: Maintenance Adalimumab Experimental Treatment 1 Intervention

Participants who respond to adalimumab induction group 3 will continue to receive adalimumab per label in the maintenance period.

Group VI: Induction Group 3 Experimental Treatment 1 Intervention

Participants will receive adalimumab per label throughout induction.

Group VII: Induction Group 2 Experimental Treatment 1 Intervention

Participants will receive Dose 2 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction.

Group VIII: Induction Group 1 Experimental Treatment 1 Intervention

Participants will receive Dose 1 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction.

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06257875

NCT06257875 | A Study to Assess Adverse Events and ... 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 ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M23-703

A Study to Assess Adverse Events and Change in Disease ... A study to assess adverse events and change in disease activity from intravenous (IV) and subcutaneous (SC) Lutikizumab in adult participants with active ...

3. fiercebiotech.com fiercebiotech.com/biotech/abbvies-il-1-asset-misses-mark-monotherapy-phase-2-ulcerative-colitis-study

AbbVie ends development of IL-1 asset in ulcerative colitis “Lutikizumab showed numerically higher efficacy for the primary endpoint of endoscopic improvement compared to Humira, which was the control arm ...

4. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-lutikizumab-and-adalimumab-for-adults-with-moderate-to-severe-ulcerative-colitis/

Study on the Safety and Effectiveness of Lutikizumab ... The purpose of the study is to evaluate how well lutikizumab works in reducing the symptoms of ulcerative colitis and to monitor any side effects. The study ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20574787

Clinical Trials The purpose of this study is to assess how safe and effective lutikizumab is in adult subjects with UC and how lutikizumab compares to ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06257875

NCT06257875 | A Study to Assess Adverse Events and ... 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 ...

7. news.abbvie.com news.abbvie.com/2024-01-08-Lutikizumab-Showed-Positive-Results-in-a-Phase-2-Trial-of-Adults-with-Moderate-to-Severe-Hidradenitis-Suppurativa-as-Program-Advances-to-Phase-3

Lutikizumab Showed Positive Results in a Phase 2 Trial of ... All doses were generally well-tolerated. ... Serious adverse events (SAEs) occurred in 5.3 percent of the combined lutikizumab treatment group and ...

8. humanforschung-schweiz.ch humanforschung-schweiz.ch/en/trial-search/study-detail/65223/translate/en/?cHash=8d937468b4ecbee99d7c6d5a66ddeb11

Efficacy and safety of Lutikizumab in study participants with ... The aim of this study is to assess the safety and efficacy of Lutikizumab in adult patients with UC and to compare Lutikizumab and Adalimumab in the treatment ...