Eltrekibart for Hidradenitis Suppurativa

Recruiting at84 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Eli Lilly and Company

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

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called eltrekibart to find the most effective treatment for adults with moderate-to-severe hidradenitis suppurativa. The goal is to see if it can safely and effectively reduce symptoms by targeting inflammation pathways.

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.

What makes the drug Eltrekitibart unique for treating hidradenitis suppurativa?

Eltrekibart is unique because it targets specific immune pathways by acting as a monoclonal antibody against CXCR1/2, which are involved in inflammation, potentially offering a new approach compared to existing treatments that focus on different immune targets. ^{1 2 3 4 5}

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

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Eltrekitibart (Monoclonal Antibodies)

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.

Participant Groups

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

Findings from Research

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial. [2023]

2. United States 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. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Guselkumab, Risankizumab, and Tildrakizumab in the Management of Hidradenitis Suppurativa: A Review of Existing Trials and Real-Life Data. [2023]

4. Denmark 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Alterations in innate immunity and epithelial cell differentiation are the molecular pillars of hidradenitis suppurativa. [2021]