Hidradenitis Suppurativa Study of Izokibep

• Status: Recruiting
• Trial end date: 2025-12-02
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ACELYRIN Inc.

Criteria

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