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The trial is taking place at:
H

Holdsworth House Medical Practice | Sydney, Australia

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

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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

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

Trial contacts and locations

67

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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