Status:
COMPLETED
Hidradenitis Suppurativa Phase 2b Study of Izokibep
Lead Sponsor:
ACELYRIN Inc.
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 imm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2024
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT05355805
Start Date
May 5 2022
End Date
February 21 2024
Last Update
June 3 2025
Active Locations (44)
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1
Clinical Research Site
Birmingham, Alabama, United States, 35233-3110
2
Clinical Research Site
Encino, California, United States, 91436-2428
3
Clinical Research Site
Fountain Valley, California, United States, 92708-3701
4
Clinical Research Site
Los Angeles, California, United States, 90033