Hidradenitis Suppurativa Phase 2b Pivotal Study of Izokibep

  • STATUS
    Recruiting
  • End date
    Feb 1, 2024
  • participants needed
    180
  • sponsor
    ACELYRIN Inc.
Updated on 1 July 2022
antibiotics
abscess
interleukin
antiseptics

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 immunogenicity of izokibep administered subcutaneously (SC) in adult subjects with moderate to severe HS.

Details
Condition Hidradenitis Suppurativa
Treatment Izokibep, Placebo to izokibep
Clinical Study IdentifierNCT05355805
SponsorACELYRIN Inc.
Last Modified on1 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

General
Subject or legally authorized representative 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
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 intervention
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 ≥ 3 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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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