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TerminatedPhase 3

Hidradenitis Suppurativa Study of Izokibep

Key facts

Who runs it
ACELYRIN Inc.
Where
Arlington, Atlanta, Baton Rouge, Birmingham, Boardman, Boca Raton, Boston, Brandon, Canton, Charlotte, Charlottesville, Coral Gables, Encino, Fayetteville, Fountain Valley, Fremont, Frisco, Hershey, Hollywood, Indianapolis, Largo, Lebanon, Los Angeles, Mason, Murray, New Orleans, New York, Pflugerville, Pittsburgh, Plainfield, Portland, San Antonio, Sandy Springs, Santa Monica, Savannah, Scottsdale, Springfield, Springville, Sugarloaf, Tampa, The Woodlands, Thompson's Station, Topeka, Troy, Webster, and West Jordan, United StatesSee the 46 sitesAlso in 7 other countries, 52 sites
Status
Terminated
Phase
Phase 3
People taking part
258 people enrolled
Started
22 Jun 2023
Ended
27 Jan 2025
Type of study
Interventional, 2 groups
Treatments tested
  • Placebo
  • Izokibep
Record updated
15 October 2025
Why it stopped
Per our 13Aug24 press release, we announced discontinuation of internal development in this indication. This decision was not due to safety reasons.

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • General
  • Participant has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in protocol
  • 18 years of age or older
  • No known history of active tuberculosis unless adequately treated according to World Health Organization/Center for Disease Control and Prevention therapeutic guidance and determined to be fully recovered by a tuberculosis specialist; Type of Participant 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 AN count of ≥ 5 at screening and Day 1 prior to enrollment/randomization
  • Participant 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 or a minimum of 3 days a week over-the-counter topical antiseptics
  • Participant must be willing to complete a daily skin pain diary

Who cannot take part

  • Outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization
  • 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)
  • Medical Conditions
  • 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
  • Uncontrolled, clinically significant system disease
  • History of demyelinating disease or neurological symptoms suggestive of demyelinating disease
  • Malignancy within 5 years
  • Active infection or history of certain infections
  • Known history of human immunodeficiency virus (HIV); Other protocol defined Inclusion/Exclusion criteria may apply
  • Draining fistula count of > 20
  • Chronic pain not associated with HS
  • The participant is at risk of self-harm or harm to others

Where in United States

Also in 7 other countries, 52 sites

  • Arlington, VirginiaHospital not named in the registryNo longer taking part
  • Atlanta, GeorgiaHospital not named in the registryNo longer taking part
  • Baton Rouge, LouisianaHospital not named in the registryNo longer taking part
  • Birmingham, AlabamaHospital not named in the registryNo longer taking part
  • Boardman, OhioHospital not named in the registryNo longer taking part
  • Boca Raton, FloridaHospital not named in the registryNo longer taking part
  • Boston, MassachusettsHospital not named in the registryNo longer taking part
  • Brandon, FloridaHospital not named in the registryNo longer taking part
  • Canton, MichiganHospital not named in the registryNo longer taking part
  • Charlotte, North CarolinaHospital not named in the registryNo longer taking part
  • Charlottesville, VirginiaHospital not named in the registryNo longer taking part
  • Coral Gables, FloridaHospital not named in the registryNo longer taking part
  • Encino, CaliforniaHospital not named in the registryNo longer taking part
  • Fayetteville, North CarolinaHospital not named in the registryNo longer taking part
  • Fountain Valley, CaliforniaHospital not named in the registryNo longer taking part
  • Fremont, CaliforniaHospital not named in the registryNo longer taking part
  • Frisco, TexasHospital not named in the registryNo longer taking part
  • Hershey, PennsylvaniaHospital not named in the registryNo longer taking part
  • Hollywood, FloridaHospital not named in the registryNo longer taking part
  • Indianapolis, IndianaHospital not named in the registryNo longer taking part
  • Largo, MarylandHospital not named in the registryNo longer taking part
  • Lebanon, New HampshireHospital not named in the registryNo longer taking part
  • Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
  • Mason, OhioHospital not named in the registryNo longer taking part
  • Murray, KentuckyHospital not named in the registryNo longer taking part
  • New Orleans, LouisianaHospital not named in the registryNo longer taking part
  • New YorkHospital not named in the registryNo longer taking part
  • Pflugerville, TexasHospital not named in the registryNo longer taking part
  • Pittsburgh, PennsylvaniaHospital not named in the registryNo longer taking part
  • Plainfield, IndianaHospital not named in the registryNo longer taking part
  • Portland, OregonHospital not named in the registryNo longer taking part
  • San Antonio, TexasHospital not named in the registryNo longer taking part
  • Sandy Springs, GeorgiaHospital not named in the registryNo longer taking part
  • Santa Monica, CaliforniaHospital not named in the registryNo longer taking part
  • Savannah, GeorgiaHospital not named in the registryNo longer taking part
  • Scottsdale, ArizonaHospital not named in the registryNo longer taking part
  • Springfield, MassachusettsHospital not named in the registryNo longer taking part
  • Springville, UtahHospital not named in the registryNo longer taking part
  • Sugarloaf, PennsylvaniaHospital not named in the registryNo longer taking part
  • Tampa, FloridaHospital not named in the registryNo longer taking part
  • The Woodlands, TexasHospital not named in the registryNo longer taking part
  • Thompson's Station, TennesseeHospital not named in the registryNo longer taking part
  • Topeka, KansasHospital not named in the registryNo longer taking part
  • Troy, MichiganHospital not named in the registryNo longer taking part
  • Webster, TexasHospital not named in the registryNo longer taking part
  • West Jordan, UtahHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

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 participants with active Hidradenitis Suppurativa (HS), including tumor necrosis factor-alpha inhibitor (TNFi) naïve participants, and those who had an inadequate response or intolerance to TNFi, or for whom TNFi is contraindicated.

The 2 groups in the trial

  • Group 1Treatment being tested

    Participants will receive placebo as a subcutaneous (SC) injection every week (QW) from Day 1 to Week 15. Participants will then receive izokibep as a SC injection QW from Week 16 to Week 51.

    Treatment: Placebo and Izokibep

  • Group 2Treatment being tested

    Participants will receive izokibep QW from Day 1 to Week 51.

    Treatment: Izokibep

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa
Record updated
15 October 2025