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Completed

NCT Number: NCT05355805

Hidradenitis Suppurativa Phase 2b Study of Izokibep

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.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Site, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

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.

Treatment and study plan

Izokibep

Drug

Biologic: IL-17A inhibitor

Form: Solution for injection

Route of administration: Subcutaneous (SC)

Placebo to izokibep

Drug

Form: Solution for injection

Route of administration: Subcutaneous (SC)

Primary outcomes

  1. Part A: Number of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12

    Time frame: Part A: Baseline to Week 12

    HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.

  2. Part B: Number of Participants Who Achieved HiSCR75 at Week 16

    Time frame: Part B: Baseline to Week 16

    HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.

Secondary outcomes

  1. Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks

    An adverse event (AE) referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.

  2. Part A: Number of Participants Testing Positive for Anti-drug Antibodies (ADAs)

    Time frame: Baseline, Week 16, Week 32, Week 39

    Blood samples were collected at different time points throughout the study.

  3. Part B: Number of Participants Who Achieved HiSCR90 at Week 16

    Time frame: Part B: Baseline to Week 16

    HiSCR90 was defined as at least a 90% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count

  4. Part B: Number of Participants Who Achieved HiSCR100 at Week 16

    Time frame: Part B: Baseline to Week 16

    HiSCR100 was defined as at least a 100% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.

  5. Part B: Number of Participants Who Achieved HiSCR50 at Week 16

    Time frame: Part B: Baseline to Week 16

    HiSCR50 was defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count

  6. Part B: Percentage of Participants Who Experienced ≥ 1 Disease Flare Through 16 Weeks of Treatment

    Time frame: Part B: Day 1 through to Week 16

    A flare was defined as ≥ 25% increase in AN count with a minimum increase of 2 AN relative to baseline.

    Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern. Predictors in the regression model for missing values at Week 4 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, body mass index (BMI) and prior Biologic/JAK inhibitor use for HS. Predictors in the regression model for missing values after Week 4 are all of these variables, plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.

  7. Part B: Number of Participants With Hurley Stage II at Baseline Who Achieved AN Count of 0, 1, or 2

    Time frame: Part B: Week 16

    The percentage of participants with baseline Hurley Stage II who achieved AN count of 0, 1, or 2 at Week 16.

    Hurley stages:

    Stage 1 - solitary or multiple, isolated abscess formation without scarring or sinus tracts Stage 2 - recurrent abscesses, single or multiple widely separated lesions, with sinus tract formation Stage 3 - diffuse or broad involvement, with multiple interconnected sinus tracts and abscesses.

  8. Part B: Number of Participants Who Achieved at Least a 3-Point Reduction From Baseline in Numeric Rating Scale (NRS) in Patient Global Assessment of Skin Pain at Its Worst at Week 16 Among Participants With Baseline NRS ≥ 4

    Time frame: Part B: Baseline to Week 16

    The Patient Global Assessment of Skin Pain is a NRS that consists of scores from 0 to 10 with 0 indicating "no skin pain" and 10 indicating "pain as bad as you can imagine".

  9. Part B: Number of Participants With TEAEs of Special Interest

    Time frame: Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks

    Adverse events of special interest were adverse events in the following categories: candida infection, inflammatory bowel disease, suicidal ideation, malignancies, major cardiovascular and cerebrovascular events, tuberculosis, infections, cytopenias and hypersensitivity reactions.

  10. Part B: Number of Participants With TEAEs

    Time frame: Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks

    An AE referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. SAEs were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.

  11. Part B: Number of Participants Testing Positive for ADAs

    Time frame: Up to 39 weeks

    Blood samples were collected at different time points throughout the study.

Sponsors and collaborators

Lead sponsor

ACELYRIN Inc.

Industry

Registry information

Official study title

A Phase 2b Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 2, 2022
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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