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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Placebo; Drug: Eltrekibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT06046729

U1111-1292-6255 (Other Identifier)

2023-505608-43-00 (Other Identifier)

18518

I7P-MC-DSAF (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 4 patient groups, including a placebo group

Eltrekibart Dose 1

Experimental group

Description:

Eltrekibart will be given subcutaneously (SC).

Treatment:

Drug: Eltrekibart

Eltrekibart Dose 2

Experimental group

Description:

Eltrekibart will be given SC.

Treatment:

Drug: Eltrekibart

Eltrekibart Dose 3

Experimental group

Description:

Eltrekibart will be given SC.

Treatment:

Drug: Eltrekibart

Placebo

Placebo Comparator group

Description:

Placebo will be given.

Treatment:

Drug: Placebo