Hidradenitis Suppurativa Phase 2b Study of Izokibep

ACELYRIN

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Izokibep; Drug: Placebo to izokibep

Study type: Interventional

Funder types: Industry

Identifiers

NCT05355805

21102

2021-005713-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 for at least 3 days prior to Day 1 visit.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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205 participants in 5 patient groups, including a placebo group

Part A (Open-label) izokibep every week

Experimental group

Description:

Participants will receive izokibep every week from Day 1 through Week 31

Treatment:

Drug: Izokibep

Part B (Double-blind) izokibep every week

Experimental group

Description:

Participants will receive izokibep every week for 31 weeks.

Treatment:

Drug: Izokibep

Part B (Double-blind) izokibep every other week

Experimental group

Description:

Participants will receive izokibep every other week for 30 weeks.

Treatment:

Drug: Izokibep

Part B (Double-blind) placebo every week

Placebo Comparator group

Description:

Participants will receive placebo every week up to Week 15, then izokibep from Week 16 to Week 31.

Treatment:

Drug: Placebo to izokibep

Part B (Double-blind) placebo every other week

Placebo Comparator group

Description:

Participants will receive placebo every other week up to Week 14, then izokibep from Week 16 to Week 30.

Treatment:

Drug: Placebo to izokibep