A Study of LY3041658 in Adults With Hidradenitis Suppurativa

Eli Lilly and Company72 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

PlaceboDRUG

Administered IV

LY3041658DRUG

Administered IV

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (20)

Northwest Arkansas Clinical Trials Center

Rogers, Arkansas, United States

First OC Dermatology

Outcomes

Primary Outcomes

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16

The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (sum of abscesses and inflammatory nodules \[AN count\]) with no increase in abscess count (A count) and no increase in draining fistulae count (DF count) relative to baseline. Non-responder imputation (NRI): Participants with missing data were considered non-responders.

Time frame: Week 16

Secondary Outcomes

Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count

Mean Change from baseline in total AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the Hidradenitis Suppurativa (HS) affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Time frame: Baseline, Week 16

Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)

The Skin Pain - HS Numeric Rating Scale (NRS) is a patient-administered, single-question, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no skin pain" and 10 representing "skin pain as bad as you can imagine." The recall period is 7 days.

Time frame: Baseline, Week 16

Data from ClinicalTrials.gov

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