Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ACELYRIN Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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).
Clareo Health | Hidradenitis Suppurativa Phase 2b Study of Izokibep
