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Monoclonal Antibodies

Eltrekibart for Hidradenitis Suppurativa

Phase 2

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III.

Had an inadequate response or intolerance to a 28-day course of oral antibiotics.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

Study Summary

This trial studies the safety and effectiveness of a drug to treat moderate-to-severe hidradenitis suppurativa (HS). It may last up to 62 weeks and include up to 31 visits.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects of Eltrekibart are not listed here, common side effects from similar treatments may include skin reactions at injection sites, potential allergic responses, fatigue, headache and gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I agree to use skin cleaners daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

Secondary outcome measures

Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)

Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules

Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Eltrekibart Dose 3Experimental Treatment1 Intervention

Eltrekibart will be given SC.

Group II: Eltrekibart Dose 2Experimental Treatment1 Intervention

Eltrekibart will be given SC.

Group III: Eltrekibart Dose 1Experimental Treatment1 Intervention

Eltrekibart will be given subcutaneously (SC).

Group IV: PlaceboPlacebo Group1 Intervention

Placebo will be given.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,620 Previous Clinical Trials

3,216,249 Total Patients Enrolled

1 Trials studying Hidradenitis Suppurativa

72 Patients Enrolled for Hidradenitis Suppurativa

Study DirectorEli Lilly and Company

1,348 Previous Clinical Trials

415,395 Total Patients Enrolled

1 Trials studying Hidradenitis Suppurativa

72 Patients Enrolled for Hidradenitis Suppurativa

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new enrollees still being welcomed into this trial?

"According to clinicialtrials.gov, this research endeavour is currently searching for participants to enroll. The trial was initially posted on October 23rd of 2023 and its most recent update was also made in the same month."

Answered by AI

Does this research include individuals aged 50 or above?

"This study is open to individuals aged 18-75, while 4 trials are offered to those younger and 36 for seniors."

Answered by AI

What are the potential health risks associated with Eltrekibart Dose 1?

"Our internal assessment of Eltrekibart Dose 1's safety is a 2. This rating was reached since there exists evidence to support its security, however no indications are present which demonstrate its efficacy."

Answered by AI

How many subjects are participating in this experiment?

"Yes, per records available on clinicaltrials.gov, recruitment for this medical study is currently underway with the initial posting having occurred on October 23rd 2023 and a subsequent edit taking place at that same date. The trial requires 350 participants from one location."

Answered by AI

To what extent is enrollment in this clinical trial open to the public?

"This clinical trial, targeting those with Hidradenitis suppurativa aged 18-75 years old, is looking to recruit 350 participants. Among other requirements, potentials must have had a diagnosis for at least 12 months, lesions in two distinct sites (one of which being Hurley Stage II/III), an abscess plus inflammatory nodule count of 5 or more and agree to use topical antiseptics daily; they should also have previously failed to respond positively or been intolerant to oral antibiotics taken over 28 days."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

2023. "A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06046729.

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