Hidradenitis Suppurativa Study of Izokibep

ACELYRIN

Status and phase: Active, not recruiting; Phase 3

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Placebo; Drug: Izokibep

Study type: Interventional

Funder types: Industry

Identifiers

NCT05905783

22107

2022-503160-33-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 258 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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258 participants in 2 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Drug: Izokibep

Drug: Placebo

Group 2

Experimental group

Description:

Participants will receive izokibep QW from Day 1 to Week 51.

Treatment:

Drug: Izokibep