Hidradenitis Suppurativa Phase 2b Pivotal Study of Izokibep

Study Overview
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Brief Summary
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Izokibep is a potent and selective inhibitor of interleukin 17A (IL-17A) that is being developed for treatment of hidradenitis suppurativa (HS). This study will evaluate the efficacy, safety, and immunogenicity of izokibep administered subcutaneously (SC) in adult subjects with moderate to severe HS.

Official Title
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A Phase 2b Pivotal 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: Izokibep
* Drug: Placebo to 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 years to 75 years of age Type of Subject and Disease Characteristics Diagnosis of hidradenitis suppurativa (HS) for ≥ 1 year prior to first dose of study drug. Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas , one of which is Hurley Stage II or 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. 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 ≤ 3 months of screening 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 |
| --- | --- |
| Experimental: Part A (Open-label) izokibep every week<br>Participants will receive izokibep every week from Day 1 through Week 31 | Drug: Izokibep<br>* Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)<br>|
| Experimental: Part B (Double-blind) izokibep every week<br>Participants will receive izokibep weekly for 31 weeks. | Drug: Izokibep<br>* Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)<br>|
| Experimental: Part B (Double-blind) izokibep every other week<br>Participants will receive izokibep every other week for 30 weeks. | Drug: Izokibep<br>* Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)<br>|
| Placebo Comparator: Part B (Double-blind) placebo every week<br>Participants will receive placebo weekly up to Week 15, then izokibep from Week 16 to Week 31. | Drug: Placebo to izokibep<br>* Form: Solution for injection Route of administration: Subcutaneous (SC)<br>|
| Placebo Comparator: Part B (Double-blind) placebo every other week<br>Participants will receive placebo every other week up to Week 14, then izokibep from Week 16 to Week 30. | Drug: Placebo to izokibep<br>* 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 |
| --- | --- | --- |
| Part A: Hidradenitis suppurativa clinical response (HiSCR75) |  | Part A: Week 12 | 
| Part B: Hidradenitis suppurativa clinical response (HiSCR75) |  | Part B: Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Incidence of treatment-emergent adverse events (TEAEs) |  | Part A: Screening (Day -28) to Follow-up Week 39 | 
| Part A: Incidence of serious adverse events (SAEs) |  | Part A: Screening (Day -28) to Follow-up Week 39 | 
| Part A: Incidence of clinically significant changes in laboratory values |  | Part A: Screening (Day -28) to Follow-up Week 39 | 
| Part A: Incidence of clinically significant changes in vital signs |  | Part A: Screening (Day -28) to Follow-up Week 39 | 
| Part A: Laboratory data confirming presence of anti-drug antibodies at each planned collection timepoint | In patients treated with izokibep: the detection and characterization of antibodies to izokibep will be performed via assay. | Part A: Day 1, Weeks 4, 8, 12, 16, 24, 32 and at follow-up (Weeks 39 and 45) | 
| Part B: Percent of subjects achieving HiSCR90 |  | Part B: Week 16 | 
| Part B: Percent of subjects achieving HiSCR100 |  | Part B: Week 16 | 
| Part B: Percent of subjects achieving HiSCR50 |  | Part B: Week 16 | 
| Part B: Percentage of subjects who experience ≥ 1 disease flare through 16 weeks of treatment |  | Part B: Day 1 through to Week 16 | 
| Part B: Percent of subjects with Hurley Stage II at baseline who achieve Abscess and Inflammatory Nodule (AN) count of 0, 1, or 2 |  | Part B: Week 16 | 
| Part B: Percentage of subjects achieving at least 3 point reduction from baseline in Numeric Rating Scale (NRS) in Patient Global Assessment of Skin Pain at its worst at Week 16 among participants with baseline NRS ≥ 4 |  | Part B: Week 16 | 
| Part B: Incidence of treatment-emergent adverse events (TEAEs) |  | Part B: Screening (Day -28) to Follow-up (Week 39) | 
| Part B: Incidence of events of interest |  | Part B: Screening (Day -28) to Follow-up (Week 39) | 
| Part B: Incidence of serious adverse events (SAEs) |  | Part B: Screening (Day -28) to Follow-up (Week 39) | 
| Part B: Incidence of clinically significant changes in laboratory values |  | Part B: Screening (Day -28) to Follow-up (Week 39) | 
| Part B: Incidence of clinically significant changes in vital signs |  | Part B: Screening (Day -28) to Follow-up (Week 39) | 
| Part B: Laboratory data confirming presence of anti-drug antibodies at each planned collection timepoint | In patients treated with izokibep: the detection and characterization of antibodies to izokibep will be performed via assay. | Part B: Day 1, Weeks 4, 8, 12, 16, 24, 32 and at follow-up (Weeks 39 and 45) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hidradenitis suppurativa, Izokibep