A Study of LY3041658 in Adults With Hidradenitis Suppurativa

Lilly

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Placebo; Drug: LY3041658

Study type: Interventional

Funder types: Industry

Identifiers

NCT04493502

I7P-MC-DSAD (Other Identifier)

17497

Details and patient eligibility

About

The reason for this study is to see if the study drug LY3041658 is effective in participants with moderate-to-severe hidradenitis suppurativa (HS).

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis of HS for at least 6 months
• Have HS lesions in at least 2 different anatomic areas
• Have inadequate response or intolerance to a 28 day course of oral antibiotics
• Have a total count of abscesses and inflammatory nodules greater than or equal to 4
• Agree to use a topical antiseptic daily
• Agree to stop using topical antibiotics during the study. In certain cases, oral antibiotics will be allowed

Exclusion criteria

• Have more than 20 draining fistulae
• Have received any biologic medication (adalimumab, etc.) for the treatment of HS
• Plan to use oral opioids for HS-related pain during the study
• Uncontrolled depression or suicidal thoughts

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

LY3041658

Experimental group

Description:

Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).

Treatment:

Drug: LY3041658

Placebo

Placebo Comparator group

Description:

Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.

Treatment:

Drug: LY3041658

Drug: Placebo