Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
205 participants
INTERVENTIONAL
2022-05-05
2024-02-21
Brief Summary
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This study will evaluate the efficacy, safety, and immunogenicity of izokibep administered subcutaneously (SC) in adult subjects with moderate to severe HS.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part A (Open-label) izokibep every week
Participants will receive izokibep every week from Day 1 through Week 31
Izokibep
Biologic: IL-17A inhibitor
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Part B (Double-blind) izokibep every week
Participants will receive izokibep every week for 31 weeks.
Izokibep
Biologic: IL-17A inhibitor
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Part B (Double-blind) izokibep every other week
Participants will receive izokibep every other week for 30 weeks.
Izokibep
Biologic: IL-17A inhibitor
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Part B (Double-blind) placebo every week
Participants will receive placebo every week up to Week 15, then izokibep from Week 16 to Week 31.
Placebo to izokibep
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Part B (Double-blind) placebo every other week
Participants will receive placebo every other week up to Week 14, then izokibep from Week 16 to Week 30.
Placebo to izokibep
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Interventions
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Izokibep
Biologic: IL-17A inhibitor
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Placebo to izokibep
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
75 Years
ALL
No
Sponsors
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ACELYRIN Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Donald Betah, MD
Role: STUDY_DIRECTOR
ACELYRIN Inc.
Locations
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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
Clinical Research Site
Bad Bentheim, Lower Saxony, Germany
Clinical Research Site
Bochum, Northwest, Germany
Clinical Research Site
Kiel, Schleswig-Holstein, Germany
Clinical Research Site
Kiel, Schleswig-Holstein, Germany
Clinical Research Site
Schwerin, , Germany
Clinical Research Site
Budapest, BU, Hungary
Clinical Research Site
Debrecen, HB, Hungary
Clinical Research Site
Krakow, Lesser Poland Voivodeship, Poland
Clinical Research Site
Krakow, Lesser Poland Voivodeship, Poland
Clinical Research Site
Wroclaw, Lower Silesian Voivodeship, Poland
Clinical Research Site
Wroclaw, Lower Silesian Voivodeship, Poland
Clinical Research Site
Bialystok, Podlaskie Voivodeship, Poland
Clinical Research Site
Katowice, Silesian Voivodeship, Poland
Clinical Research Site
Lublin, , Poland
Clinical Research Site
Szczecin, , Poland
Clinical Research Site
Palma de Mallorca, PM, Spain
Clinical Research Site
Pontevedra, PO, Spain
Clinical Research Site
Manises, V, Spain
Clinical Research Site
Barcelona, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-005713-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
21102
Identifier Type: -
Identifier Source: org_study_id
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