Hidradenitis Suppurativa Phase 2b Pivotal Study of Izokibep

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ACELYRIN Inc.

Criteria

Inclusion Criteria:

General

• Subject or legally authorized representative 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 intervention.

• 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 ≥ 3 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