A Study of LY3041658 in Adults With Hidradenitis Suppurativa

Phase 2

Completed

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
LY3041658	LY3041658	Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).
Placebo	Placebo	Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.
Placebo	LY3041658	Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)	Baseline, Week 16	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.
Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count	Baseline, Week 16	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.

Locations (20): Northwest Arkansas Clinical Trials Center
🇺🇸
Rogers, Arkansas, United States
First OC Dermatology
🇺🇸
Fountain Valley, California, United States
Dermatology Research Associates
🇺🇸
Los Angeles, California, United States
Skin Care Research, Inc
🇺🇸
Hollywood, Florida, United States
Nova Clinical Research, LLC
🇺🇸
Miami, Florida, United States
ForCare Clinical Research
🇺🇸
Tampa, Florida, United States
Marietta Dermatology Clinical Research
🇺🇸
Marietta, Georgia, United States
Advanced Medical Research
🇺🇸
Sandy Springs, Georgia, United States
Allcutis Research, Inc.
🇺🇸
Beverly, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
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Northwest Arkansas Clinical Trials Center
🇺🇸Rogers, Arkansas, United States