Eltrekibart for Hidradenitis Suppurativa

Not currently recruiting at 89 trial locations

Overseen By Lindsay Ackerman

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Active skin disease, Immunocompromised, Drug abuse, others

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

Compensation: Varies

Number of Visits: 31

Duration: 58-60 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called eltrekibart for individuals with moderate-to-severe hidradenitis suppurativa (HS), a skin condition that causes painful lumps. Researchers aim to determine the optimal dose and schedule for this medicine. Participants will receive either varying doses of eltrekibart or a placebo (a substance with no active treatment) over approximately 62 weeks. Eligibility requires having HS for at least a year, with sores in at least two body areas and a history of poor response to antibiotics. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to potential advancements in HS treatment.

Do I have to stop taking my current medications for the trial?

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 eltrekibart has been tested for safety in people with moderate-to-severe hidradenitis suppurativa. In earlier studies, patients generally tolerated eltrekibart well. The most common side effects were mild, including headaches and injection site reactions, which are typical for injectable treatments. No serious side effects were directly linked to the treatment. This suggests that eltrekibart is generally safe for people, based on data from previous research. ^{1 2 3 4 5}

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

Eltrekibart is unique for treating Hidradenitis Suppurativa because it offers a potentially novel approach compared to current options like antibiotics, anti-inflammatory drugs, and biologics such as TNF inhibitors. Most treatments for this condition work by reducing inflammation or fighting infection. However, Eltrekibart is designed to be administered subcutaneously and may work by targeting specific pathways involved in the disease's progression. Researchers are excited about Eltrekibart because it could provide a more targeted treatment, potentially improving effectiveness and reducing side effects compared to existing therapies.

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

Studies have shown that eltrekibart may help treat moderate-to-severe hidradenitis suppurativa (HS), a condition that causes painful skin lumps. This trial will evaluate different doses of eltrekibart, which targets a part of the body involved in inflammation. In earlier research, many patients who took eltrekibart experienced improvements, with a significant number seeing a 50% reduction in skin lesions by week 16. These findings suggest that eltrekibart could help reduce the painful skin symptoms of HS. ^{1 2 3 4 5}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

Adults with moderate-to-severe hidradenitis suppurativa (HS) for at least a year, lesions in two areas with one being Hurley Stage II/III, and an inadequate response to oral antibiotics can join. Those with over 20 draining fistulae, recent HS surgery, other skin conditions that could affect HS assessment, active infections or compromised immunity cannot participate.

Inclusion Criteria

I have been diagnosed with HS for over a year.

I have HS lesions in 2 different body areas, with at least one being moderate to severe.

I did not improve or couldn't tolerate a month-long course of antibiotics.

Exclusion Criteria

You have more than 20 open sores that are draining fluid.

Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening.

I have a skin condition that might affect HS assessment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive eltrekibart or placebo subcutaneously to determine the safe and effective dose and dosing frequency

58-60 weeks

Up to 31 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Eltrekitibart

Trial Overview The trial is testing Eltrekibart's safety and effective dose against a placebo in adults with HS. Participants will be randomly assigned to receive either the drug or placebo for about 62 weeks across potentially 31 visits to determine the best dosage frequency for further studies.

How Is the Trial Designed?

Group I: Eltrekibart Dose 3 Experimental Treatment 1 Intervention

Eltrekibart will be given SC.

Group II: Eltrekibart Dose 2 Experimental Treatment 1 Intervention

Eltrekibart will be given SC.

Group III: Eltrekibart Dose 1 Experimental Treatment 1 Intervention

Eltrekibart will be given subcutaneously (SC).

Group IV: Placebo Placebo Group 1 Intervention

Placebo will be given.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

A review of 64 articles on anti-IL23 drugs (guselkumab, tildrakizumab, and risankizumab) for treating hidradenitis suppurativa (HS) suggests these medications may be effective, but their benefits appear limited to specific patient subgroups.

Current Phase 2 studies show mixed results, indicating a need for more comprehensive Phase 3 studies and real-life data to better assess the safety and efficacy of anti-IL23 treatments for HS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab, Risankizumab, and Tildrakizumab in the Management of Hidradenitis Suppurativa: A Review of Existing Trials and Real-Life Data. Martora, F., Scalvenzi, M., Battista, T., et al.[2023]

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]

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]

In a phase 2 study involving 209 patients with hidradenitis suppurativa, povorcitinib, a selective Janus kinase 1 inhibitor, significantly reduced the number of abscesses and inflammatory nodules compared to placebo over 16 weeks.

Povorcitinib also showed a higher percentage of patients achieving clinical response at week 16, with no increase in adverse events compared to placebo, indicating its potential as a safe and effective treatment for HS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the oral Janus kinase 1 inhibitor povorcitinib (INCB054707) in patients with hidradenitis suppurativa in a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study. Kirby, JS., Okun, MM., Alavi, A., et al.[2023]

A study using whole transcriptome profiling identified key regulatory pathways involved in hidradenitis suppurativa (HS), including glucocorticoid receptor and IL17A signaling, which may drive the disease's mechanisms.

Sixteen specific genes were found to characterize HS at a molecular level, and proteins associated with immune response were strongly expressed in affected skin areas, suggesting that HS involves significant immune-related processes affecting skin health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alterations in innate immunity and epithelial cell differentiation are the molecular pillars of hidradenitis suppurativa. Zouboulis, CC., Nogueira da Costa, A., Makrantonaki, E., et al.[2021]

Citations

1. jaad.org jaad.org/article/S0190-9622(25)02964-0/fulltext

A randomized, double-blind, placebo-controlled phase 2 ... In this phase 2 double-blind trial (NCT04493502), adults with moderate-to-severe HS were randomized 2:1 to receive eltrekibart 600 mg or ...

2. s3.eu-central-1.amazonaws.com s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress2023/36211.pdf

3484 Safety and Efficacy of LY3041658, a Novel Septa- ... The primary efficacy endpoint was the percentage of patients with Hidradenitis Suppurativa Clinical Response (HiSCR50) at W16. A prespecified analysis augmented ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41061970/

A randomized, double-blind, placebo-controlled phase 2 ... Objective: To evaluate the efficacy and safety of eltrekibart, a monoclonal antibody targeting the CXC motif chemokine receptors 1 and 2 pathway ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962225029640

A randomized, double-blind, placebo-controlled phase 2 ... Objective. To evaluate the efficacy and safety of eltrekibart, a monoclonal antibody targeting the CXCR1/2 pathway, in HS. Methods.

5. dermatologytimes.com dermatologytimes.com/view/new-data-on-investigational-agent-for-hs-presented-at-annual-meeting

New Data on Investigational Agent for HS Presented at ... The 16-week phase 2 study examined the safety and efficacy of LY3041658 for the treatment of moderate to severe HS (NCT0449350).