Hidradenitis Suppurativa Study of Izokibep

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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.

Key facts

Study ID

NCT05905783

Run by

ACELYRIN Inc.

People needed

258

Starts

2023-06-22

Expected to finish

2025-01-27

Last updated by the study team

2025-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• No known history of active tuberculosis unless adequately treated according to World Health Organization/Center for Disease Control and Prevention therapeutic guidance and determined to be fully recovered by a tuberculosis specialist
• 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

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
• 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

Where it is running

• Clinical Research Site — Scottsdale, Arizona, United States
• Clinical Research Site — Scottsdale, Arizona, United States
• Clinical Research Site — Fayetteville, Arkansas, United States
• Clinical Research Site — Encino, California, United States
• Clinical Research Site — Fountain Valley, California, United States
• Clinical Research Site — Fremont, California, United States
• Clinical Research Site — Los Angeles, California, United States
• Clinical Research Site — Santa Monica, California, United States
• Clinical Research Site — Boca Raton, Florida, United States
• Clinical Research Site — Brandon, Florida, United States
• Clinical Research Site — Coral Gables, Florida, United States
• Clinical Research Site — Hollywood, Florida, United States
• Clinical Research Site — Tampa, Florida, United States
• Clinical Research Site — Tampa, Florida, United States
• Clinical Research Site — Atlanta, Georgia, United States
• Clinical Research Site — Sandy Springs, Georgia, United States
• Clinical Research Site — Savannah, Georgia, United States
• Clinical Research Site — Springfield, Illinois, United States
• Clinical Research Site — Indianapolis, Indiana, United States
• Clinical Research Site — Plainfield, Indiana, United States
• Clinical Research Site — Topeka, Kansas, United States
• Clinical Research Site — Murray, Kentucky, United States
• Clinical Research Site — Baton Rouge, Louisiana, United States
• Clinical Research Site — Baton Rouge, Louisiana, United States
• Clinical Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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