Hidradenitis Suppurativa Study of Izokibep

Study Overview
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Brief Summary
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Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin 17A, to which it binds with high affinity. This study investigates izokibep in subjects with active Hidradenitis Suppurativa (HS), including tumor necrosis factor-alpha inhibitor (TNFi) naïve subjects, and those who had an inadequate response or intolerance to TNFi, or for whom TNFi is contraindicated.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Placebo
* Drug: Izokibep


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol 18 to 75 years of age Type of Subject and Disease Characteristics Diagnosis of HS for ≥ 6 months prior to first dose of study drug Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or Hurley Stage III A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization Subject must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS Must agree to use daily over-the-counter topical antiseptics Subject must be willing to complete a daily skin pain diary Exclusion Criteria: Medical Conditions Draining fistula count of > 20 Outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization Other active skin disease or condition that could interfere with study assessments History of active inflammatory bowel disease (IBD) OR symptoms within the last year that may be suggestive of IBD Chronic pain not associated with HS Uncontrolled, clinically significant system disease History of demyelinating disease or neurological symptoms suggestive of demyelinating disease Malignancy within 5 years The subject is at risk of self-harm or harm to others Active infection or history of certain infections Tuberculosis or fungal infection seen on available chest x-ray taken within 3 months prior to first dose of study drug or at screening (Exception: documented evidence of completed treatment and clinically resolved) Known history of human immunodeficiency virus (HIV) Other protocol defined Inclusion/Exclusion criteria may apply

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1: Placebo subcutaneous once weekly<br>Participants will receive placebo every week to week 15, then izokibep to week 51. | Drug: Placebo<br>* Form: Solution for injection Route of administration: Subcutaneous (SC)<br>Drug: Izokibep<br>* Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)<br>|
| Experimental: Group 2: Izokibep subcutaneous once weekly<br>Participants will receive izokibep every week to week 51 | Drug: Izokibep<br>* Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving HiSCR75 |  | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving HiSCR90 |  | Week 16 | 
| Percentage of subjects achieving HiSCR100 |  | Week 16 | 
| Percentage of subjects achieving HiSCR50 |  | Week 16 | 
| Percentage of subjects that experience ≥ 1 disease flare |  | Up to Week 16 | 
| Change in Dermatology Life Quality Index (DLQI) |  | Baseline to Week 16 | 
| Percentage of subjects with baseline Hurley Stage II who achieve Abscess and Inflammatory Nodule (AN) count of 0, 1, or 2 |  | Week 16 | 
| Percentage of subjects achieving at least 3 point reduction from baseline in Numeric Rating Scale (NRS) Patient Global Assessment of Skin Pain at its worst among subjects with baseline NRS ≥ 4 |  | Week 16 | 
| Incidence of treatment-emergent adverse events (TEAEs) |  | Day 1 to Follow-up (Week 59) | 
| Incidence of events of interest |  | Screening (Day -28) to Follow-up (Week 59) | 
| Incidence of serious adverse events (SAEs) |  | Screening (Day -28) to Follow-up (Week 59) | 
| Incidence of clinically significant changes in laboratory values |  | Screening (Day -28) to Follow-up (Week 59) | 
| Incidence of clinically significant change in vital signs |  | Screening (Day -28) to Follow-up (Week 59) |