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

A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06046729

Enrollment

352

Registered

2023-09-21

Start date

2023-10-23

Completion date

2026-08-17

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa

Brief summary

This study aims to find the appropriately safe and effective dose and dosing frequency for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for further clinical development. The study will last approximately 62 weeks and may include up to 31 visits.

Interventions

DRUGEltrekibart

Administered SC

DRUGPlacebo

Administered SC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Phase 2b

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Have a diagnosis of HS for at least 12 months. * 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. * Have an (abscess plus inflammatory nodule) count of at least 5. * Agree to use topical antiseptics daily. * Had an inadequate response or intolerance to a 28-day course of oral antibiotics.

Exclusion criteria

* Have more than 20 draining fistulae. * Have had surgical treatment for HS in the last 4 weeks before randomization. * Have an active skin disease or condition, that could interfere with the assessment of HS. * Have a current or recent acute, active infection. * Are immunocompromised. * Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening.

Design outcomes

Primary

Measure	Time frame
Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)	Week 16

Secondary

Measure	Time frame
Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules	Baseline, Week 16
Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)	Baseline, Week 16
Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart	Baseline through Week 16

Countries

Australia, Canada, Germany, Greece, Poland, United States

Contacts

STUDY_DIRECTORCall 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)

Eli Lilly and Company

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026