Hidradenitis Suppurativa Phase 2b Study of Izokibep

Completed · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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.

Key facts

Study ID

NCT05355805

Run by

ACELYRIN Inc.

People needed

205

Starts

2022-05-05

Expected to finish

2024-02-21

Last updated by the study team

2025-06-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Research Site — Birmingham, Alabama, United States
• Clinical Research Site — Encino, California, United States
• Clinical Research Site — Fountain Valley, California, United States
• Clinical Research Site — Los Angeles, California, United States
• Clinical Research Site — Los Angeles, California, United States
• Clinical Research Site — Ocala, Florida, United States
• Clinical Research Site — Tampa, Florida, United States
• Clinical Research Site — Sandy Springs, Georgia, United States
• Clinical Research Site — Savannah, Georgia, United States
• Clinical Research Site — Rolling Meadows, Illinois, United States
• Clinical Research Site — Indianapolis, Indiana, United States
• Clinical Research Site — Plainfield, Indiana, United States
• Clinical Research Site — Murray, Kentucky, United States
• Clinical Research Site — Baton Rouge, Louisiana, United States
• Clinical Research Site — New York, New York, United States
• Clinical Research Site — Mason, Ohio, United States
• Clinical Research Site — Portland, Oregon, United States
• Clinical Research Site — Philadelphia, Pennsylvania, United States
• Clinical Research Site — Pittsburgh, Pennsylvania, United States
• Clinical Research Site — Webster, Texas, United States
• Clinical Research Site — London, Ontario, Canada
• Clinical Research Site — Markham, Ontario, Canada
• Clinical Research Site — Waterloo, Ontario, Canada
• Clinical Research Site — Québec, Quebec, Canada
• Clinical Research Site — Saskatoon, Saskatchewan, Canada

Full record on ClinicalTrials.gov

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