Hidradenitis Suppurativa Study of Izokibep

Phase 3

Active, not recruiting

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

• Registration Number: NCT05905783
• Lead Sponsor: ACELYRIN Inc.

Brief Summary

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 participants with active Hidradenitis Suppurativa (HS), including tumor necrosis factor-alpha inhibitor (TNFi) naïve participants, and those who had an inadequate response or intolerance to TNFi, or for whom TNFi is contraindicated.

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: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-15
• Study Start: 2023-06-22
• Primary Completion: 2024-07-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Study Completion: 2025-02-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

General

• Participant has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in protocol
• 18 years of age or older

Type of Participant 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 AN count of ≥ 5 at screening and Day 1 prior to enrollment/randomization
• Participant 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 or a minimum of 3 days a week over-the-counter topical antiseptics
• Participant 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
• 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 participant 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Placebo	Participants will receive placebo as a subcutaneous (SC) injection every week (QW) from Day 1 to Week 15. Participants will then receive izokibep as a SC injection QW from Week 16 to Week 51.
Group 1	Izokibep	Participants will receive placebo as a subcutaneous (SC) injection every week (QW) from Day 1 to Week 15. Participants will then receive izokibep as a SC injection QW from Week 16 to Week 51.
Group 2	Izokibep	Participants will receive izokibep QW from Day 1 to Week 51.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving HiSCR75	Week 12

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving HiSCR100	Week 12
Change in Dermatology Life Quality Index (DLQI)	Baseline to Week 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Day 1 to Follow-up (Week 59)
Percentage of Participants With Baseline Hurley Stage II Who Achieve Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2	Baseline and Week 12
Percentage of Participants Achieving at Least 3-point Reduction From Baseline in Numeric Rating Scale (NRS) Patient Global Assessment of Skin Pain at its Worst Among Participants With Baseline NRS ≥ 4	Baseline and Week 12
Number of Participants With Events of Interest	Screening (Day -28) to Follow-up (Week 59)
Percentage of Participants Achieving HiSCR90	Week 12
Percentage of Participants That Experience ≥ 1 Disease Flare	Up to Week 12
Percentage of Participants Achieving HiSCR50	Week 12
Number of Participants With Clinically Significant Changes in Laboratory Values	Screening (Day -28) to Follow-up (Week 59)
Number of Participants With Clinically Significant Change in Vital Signs	Screening (Day -28) to Follow-up (Week 59)
Number of Participant With Serious Adverse Events (SAEs)	Screening (Day -28) to Follow-up (Week 59)

Trial Locations

Locations (1)

Clinical Research Site; 🇪🇸 Madrid, Spain