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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Eltrekibart
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Interventional Model Description: Phase 2b
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eltrekibart Dose 1<br>Eltrekibart will be given subcutaneously (SC). | Drug: Eltrekibart<br>* Administered SC<br>* Other names: LY3041658;|
| Experimental: Eltrekibart Dose 2<br>Eltrekibart will be given SC. | Drug: Eltrekibart<br>* Administered SC<br>* Other names: LY3041658;|
| Experimental: Eltrekibart Dose 3<br>Eltrekibart will be given SC. | Drug: Eltrekibart<br>* Administered SC<br>* Other names: LY3041658;|
| Placebo Comparator: Placebo<br>Placebo will be given. | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) |  | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules |  | Baseline, Week 16 | 
| Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS) |  | Baseline, Week 16 | 
| Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart |  | Baseline through Week 16 |