Clinical trial for adults from 18 to 75 years of age, with a diagnosis of hidradenitis suppurativa (HS) for at least 6 months.
Eligible individuals must have HS lesions present in 2 or more distinct body areas, with an inflammatory nodule (AN) count of ≥5. In addition, adults must have one of the following:
– Inadequate response to oral antibiotics (defined as ≥ 3-month treatment with an oral antibiotic for the treatment of HS)
– exhibited recurrence after discontinuation to, or demonstrated intolerance to, or have a contraindication to oral antibiotics for treatment
of their HS.
Participants will receive an investigational treatment (active study drug) or placebo via injection. Study medication and study-related assessments
will be provided at no cost. Reimbursement for study-related expenses may be provided.
Study participation will last about 63 weeks and involves about 17 visits to the research center.
Mason - Dermatologists of Southwest Ohio
Waterloo - Alliance Clinical Trials
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Last Update Posted: September 24, 2023
NCT05905783
ACELYRIN Inc.
Brief Summary:
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 subjects with active Hidradenitis Suppurativa (HS), including tumor necrosis factor-alpha inhibitor (TNFi) naïve subjects, and those who had an inadequate response or intolerance to TNFi, or for whom TNFi is contraindicated.
Condition or Disease:
Hidradenitis Suppurativa
Intervention/Treatment:
Drug: PlaceboPhase:
Phase 3
Ages Eligible for Study:
18 Years and 75 Years (Adult)
Sexes Eligible for Study:
All
Inclusion Criteria:
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 to 75 years of age
Type of Subject 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 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
Exclusion Criteria:
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 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 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
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