Hidradenitis Suppurativa Phase 2b Pivotal Study of Izokibep

Phase 2

Completed

• Conditions: Hidradenitis Suppurativa
• Interventions: Drug: Izokibep; Drug: Placebo to izokibep

• Registration Number: NCT05355805
• Lead Sponsor: ACELYRIN Inc.

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-02
• Study Start: 2022-05-05
• Primary Completion: 2023-08-02
• Study Completion: 2024-02-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A (Open-label) izokibep every week	Izokibep	Participants will receive izokibep every week from Day 1 through Week 31
Part B (Double-blind) izokibep every week	Izokibep	Participants will receive izokibep every week for 31 weeks.
Part B (Double-blind) izokibep every other week	Izokibep	Participants will receive izokibep every other week for 30 weeks.
Part B (Double-blind) placebo every week	Placebo to izokibep	Participants will receive placebo every week up to Week 15, then izokibep from Week 16 to Week 31.
Part B (Double-blind) placebo every other week	Placebo to izokibep	Participants will receive placebo every other week up to Week 14, then izokibep from Week 16 to Week 30.

Primary Outcome Measures

Name	Time	Method
Part A: Hidradenitis Suppurativa Clinical Response (HiSCR75)	Part A: Week 12	The number of participants in Part A who achieved hidradenitis suppurativa clinical response 75 (HiSCR75) at Week 12.
Part B: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)	Part B: Week 16	The number of participants in Part B who achieved hidradenitis suppurativa clinical response 75 (HiSCR75) at Week 16.

Secondary Outcome Measures

Name	Time	Method
Part B: Participants Achieving HiSCR90	Part B: Week 16	The number of participants in Part B who achieved hidradenitis suppurativa clinical response 90 (HiSCR90) at Week 16.
Part B: Participants Achieving HiSCR100	Part B: Week 16	The number of participants in Part B who achieved hidradenitis suppurativa clinical response 100 (HiSCR100) at Week 16.
Part B: Participants Achieving HiSCR50	Part B: Week 16	The number of participants in Part B who achieved hidradenitis suppurativa clinical response 50 (HiSCR50) at Week 16.
Part B: Participants Who Experience ≥ 1 Disease Flare Through 16 Weeks of Treatment	Part B: Day 1 through to Week 16	The number of participants in Part B who experienced ≥ 1 hidradenitis suppurativa flare through Week 16.
Part B: Participants With Hurley Stage II at Baseline Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2	Part B: Week 16	The percentage of participants with baseline Hurley Stage II who achieved AN count of 0, 1, or 2 at Week 16.; Hurley stages: Stage 1 - solitary or multiple, isolated abscess formation without scarring or sinus tracts Stage 2 - recurrent abscesses, single or multiple widely separated lesions, with sinus tract formation Stage 3 - diffuse or broad involvement, with multiple interconnected sinus tracts and abscesses.
Part B: Participants Achieving at Least 3 Point Reduction From Baseline in NRS in Patient Global Assessment of Skin Pain at Its Worst at Week 16 Among Participants With Baseline NRS ≥ 4	Part B: Week 16	Participants achieving at least 3 point reduction from baseline in NRS in Patient Global Assessment of Skin Pain at its worst at Week 16 among participants with baseline NRS ≥4 NRS = Numerical Rating Scale; The numeric rating scale (NRS) Patient Global Assessment of Skin Pain consists of scores from 0 to 10 with 0 indicating "no skin pain" and 10 indicating "pain as bad as you can imagine". The pain will be described as "skin pain at its worst in the last 24 hours" and "skin pain on average in the last 24 hours."
Part B Period 1: Incidence of Treatment-emergent Adverse Events (TEAEs) of Special Interest	Part B Period 1: Screening (Day -28) to Follow-up (Week 39)	The number of participants in Part B Period 1 with TEAEs of special interest.; Adverse events of special interest were adverse events in the following categories: candida infection, inflammatory bowel disease, suicidal ideation, malignancies, major cardiovascular and cerebrovascular events, tuberculosis, infections, cytopenias and hypersensitivity reactions.
Part B Period 1: Incidence of Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation	Part B Period 1: Screening (Day -28) to Follow-up (Week 39)	The number of participants in Part B Period 1 with TEAEs leading to discontinuation of study treatment

Trial Locations

Locations (1)

Clinical Research Site; 🇪🇸 Barcelona, Spain