A Study of LY3041658 in Adults With Hidradenitis Suppurativa

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

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3041658 in Adults With Moderate-to-Severe Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Placebo
* Drug: LY3041658


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3041658<br>Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W). | Drug: LY3041658<br>* Administered IV<br>|
| Placebo Comparator: Placebo<br>Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16. | Drug: Placebo<br>* Administered IV<br>Drug: LY3041658<br>* Administered IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, Week 16 |