Lutikizumab for Hidradenitis Suppurativa

(Intrepid Trial)

Recruiting at 294 trial locations

Overseen By ABBVIE CALL CENTER

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Hepatitis, HIV, Tuberculosis, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

1280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test an investigational drug called lutikizumab for treating moderate to severe hidradenitis suppurativa (HS), a painful skin condition that causes lumps and scars. Participants will be divided into groups to receive either lutikizumab or a placebo (a look-alike substance with no active drug) during the first part of the study. In the second part, all participants will receive lutikizumab with different dosing schedules. The trial seeks participants who have experienced moderate to severe HS for at least six months, with HS lesions in at least two different body areas. Regular clinic visits will be required for check-ups and to monitor the treatment's effects and any side effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially bringing a new treatment to market.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that lutikizumab has been tested for safety in people with moderate to severe hidradenitis suppurativa (HS). In earlier studies, most patients tolerated lutikizumab well. For instance, only a small number, between 0% and 4%, discontinued due to side effects. This indicates that most did not experience severe side effects prompting them to stop treatment.

Lutikizumab is not yet approved for HS, but it is in advanced trials, suggesting it has already demonstrated some safety in earlier tests. While side effects may still occur, these studies help ensure the drug is generally safe for participants. Those considering joining the trial might find this information reassuring regarding its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HS?

Lutikizumab is unique because it targets a specific part of the immune system involved in inflammation called IL-1, which differentiates it from current treatments for Hidradenitis Suppurativa, like antibiotics, retinoids, or TNF-alpha inhibitors. Researchers are excited about Lutikizumab because this new mechanism of action could potentially provide relief for patients who don't respond well to existing therapies. Additionally, the flexibility in dosing schedules, offering both weekly and bi-weekly options, could improve patient convenience and adherence compared to more rigid treatment regimens.

What evidence suggests that lutikizumab might be an effective treatment for hidradenitis suppurativa?

Research has shown that lutikizumab may help treat moderate to severe hidradenitis suppurativa (HS), a painful skin condition. In this trial, participants will receive lutikizumab either weekly or every other week. Earlier studies demonstrated that patients on such regimens experienced less skin pain and improved skin symptoms compared to those who did not take the drug. More patients had fewer painful lumps and abscesses, and many did not experience an increase in draining tunnels, which are channels under the skin that can leak fluid. These results suggest that lutikizumab might provide relief for people dealing with the discomfort of HS. ^{1 2 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults and adolescents with moderate to severe Hidradenitis Suppurativa (HS), a painful skin condition. Participants must have been diagnosed at least 6 months ago, have five or more abscesses or nodules, and HS lesions in two areas of the body, one being at least Hurley Stage II.

Inclusion Criteria

I have HS lesions in two or more separate areas.

I have been diagnosed with moderate to severe HS for at least 6 months.

I have 5 or more abscesses or inflamed nodules.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks

16 weeks

Weekly visits (in-person)

Treatment Period 2

Participants receive subcutaneous injections of lutikizumab every week or every other week for up to 36 weeks

36 weeks

Weekly or bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lutikizumab

Trial Overview

The study tests Lutikizumab against a placebo in treating HS. Initially, participants are randomly assigned to receive either Lutikizumab or placebo injections weekly for 16 weeks. Afterwards, they may continue with different dosing schedules of Lutikizumab for up to 36 weeks.

How Is the Trial Designed?

Group I: Sub-Study: Lutikizumab Pre-Filled Pen Experimental Treatment 1 Intervention

Lutikizumab solution for injection in prefilled pen (EOW) for 60 weeks, followed by lutikizumab solution for injection in prefilled syringes (EOW) for 96 weeks.

Group II: Period 3: Open-label Lutikizumab Experimental Treatment 1 Intervention

Starting at Week 68 in Period 3, all participants will receive Open-label Lutikizumab every other week

Group III: Period 2: Placebo to Lutikizumab Group Every Week Experimental Treatment 1 Intervention

Participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every week through Week 52

Group IV: Period 2: Placebo to Lutikizumab Group Every Other Week Experimental Treatment 2 Interventions

The participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every other week through Week 52

Group V: Period 2: Placebo to Lutikizumab Group Experimental Treatment 1 Intervention

Participants randomized to Placebo in Period 1 who complete Week 16 of the study will initiate lutikizumab with Dose B followed by Dose A every week.

Group VI: Period 2: Lutikizumab Every Week Experimental Treatment 1 Intervention

Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A through Week 52

Group VII: Period 2: Lutikizumab Every Other Week Experimental Treatment 2 Interventions

Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A every other week though week 52

Group VIII: Period 1 Experimental Treatment 2 Interventions

Participants will be randomized to either Lutikizumab Dose B at baseline followed by Lutikizumab Dose A, or a matching placebo dose equivalent for both, every week through Week 16 .

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

Published Research Related to This Trial

In adult patients with hidradenitis suppurativa (HS), adalimumab reaches steady serum concentrations of 10-12 µg/mL by week 2 and maintains these levels through week 12, indicating effective dosing.

The development of anti-adalimumab antibodies (AAA) was low (10% in phase II and 7% in phase III studies), but the presence of AAA was associated with decreased drug concentrations, which could potentially reduce the treatment's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Immunogenicity of Adalimumab in Adult Patients with Moderate-to-Severe Hidradenitis Suppurativa. Nader, A., Beck, D., Noertersheuser, P., et al.[2018]

A systematic review of 9 clinical trials involving various treatments for hidradenitis suppurativa highlighted the lack of a universally effective therapy, indicating the complexity of managing this chronic inflammatory disease.

The review included therapies such as antibiotics, hormonal treatments, and biologics, but emphasized the challenges in comparing their effectiveness due to variability in treatment outcomes and the need for better validation of outcome measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical management of hidradenitis suppurativa. Orenstein, LA., Micheletti, RG.[2018]

In a phase 2 clinical trial, the drug fostamatinib showed a 75% clinical response rate in patients with hidradenitis suppurativa, particularly benefiting those with high levels of inflammation and IgG.

Serum proteomic analysis revealed that responders to fostamatinib had significant reductions in inflammatory markers, suggesting that targeting B-cell activity may effectively alter the disease's inflammatory profile and help identify potential biomarkers for therapy response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alterations to the Hidradenitis Suppurativa Serum Proteome with Spleen Tyrosine Kinase Antagonism: Proteomic Results from a Phase 2 Clinical Trial. Flora, A., Jepsen, R., Pham, J., et al.[2023]

Adalimumab, a TNF-α inhibitor, has variable effectiveness in treating hidradenitis suppurativa (HS), highlighting the need for new therapeutic options.

Promising new treatments under investigation include anti-IL-17 biologics like bimekizumab and secukinumab, which are in phase III trials, and IL-1α targeting with bermekimab, showing encouraging results in early studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Target molecules for future hidradenitis suppurativa treatment. Zouboulis, CC., Frew, JW., Giamarellos-Bourboulis, EJ., et al.[2022]

In a phase II study involving 243 patients with moderate-to-severe hidradenitis suppurativa (HS), risankizumab did not meet the primary endpoint of achieving HS Clinical Response (HiSCR) at week 16, indicating it may not be an effective treatment for this condition.

The safety profile of risankizumab was generally favorable, with low rates of treatment-emergent adverse events across all treatment groups, suggesting that while it may not be effective, it is also not associated with significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial. Kimball, AB., Prens, EP., Passeron, T., et al.[2023]

A patient with hidradenitis suppurativa (HS) initially responded well to infliximab, a TNF-alpha antagonist, but experienced an infusion reaction, highlighting the potential for adverse effects with certain treatments.

Switching to adalimumab, another TNF-alpha inhibitor, resulted in significant and sustained improvement in the patient's condition for over 15 months, suggesting that adalimumab is a safe and effective alternative for patients who cannot tolerate infliximab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Treatment of Recalcitrant Hidradenitis Suppurativa with Adalimumab. Gorovoy, I., Berghoff, A., Ferris, L.[2021]

IL-17 inhibitors, particularly secukinumab and brodalumab, show promising efficacy in treating hidradenitis suppurativa (HS), with response rates of 57.1% and 100% respectively among 128 patients studied.

These treatments can be effective for patients who do not respond to other therapies, highlighting the need for standardized outcome measures to improve future research and clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. Kashetsky, N., Mufti, A., Alabdulrazzaq, S., et al.[2022]

In patients with severe hidradenitis suppurativa (HS), there is an increase in specific inflammatory monocytes and a unique cytokine profile, indicating a complex immune response that could guide treatment choices.

Treatment with etanercept, a TNF blocker, showed clinical improvement linked to increased production of IL-1β and IL-17 in blood cells, suggesting that monitoring these cytokines could help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compartmentalized Cytokine Responses in Hidradenitis Suppurativa. Kanni, T., Tzanetakou, V., Savva, A., et al.[2018]

In a study of 26 individuals with hidradenitis suppurativa treated with risankizumab, 69.2% achieved a significant clinical response by week 16, indicating the efficacy of IL-23 antagonism in this condition.

Clinical response was linked to male gender, higher testosterone levels, and lower FSH levels, suggesting that these hormonal markers, along with specific immune cell profiles, could serve as potential biomarkers for predicting treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline clinical, hormonal and molecular markers associated with clinical response to IL-23 antagonism in hidradenitis suppurativa: A prospective cohort study. Flora, A., Kozera, EK., Jepsen, R., et al.[2023]

Citations

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A greater proportion of patients (NRI-MI) receiving lutikizumab300mgEW and 300mgEOW achieved no increase in dTs from baseline (79.5%, 83.8%, respectively) ...

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The primary end point of the study was the achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) of a ≥50% reduction in the number ...

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A study to assess disease activity and safety of Lutikizumab in adult and adolescent participants with moderate to severe hidradenitis Suppurativa.

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A Living Systematic Review and Network Meta-Analysis

The percentage of patients discontinuing treatment due to adverse events ranged from 0% to 10% in the placebo groups, 0% to 4% in the adalimumab ...