Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
258 participants
INTERVENTIONAL
2023-06-22
2025-01-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Hidradenitis Suppurativa Phase 2b Study of Izokibep
NCT05355805
Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis
NCT05384249
A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
NCT03607487
A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
NCT03569371
Anifrolumab for Hidradenitis Suppurativa
NCT06374212
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
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.
Placebo
Solution for injection
Izokibep
Solution for injection
Group 2
Participants will receive izokibep QW from Day 1 to Week 51.
Izokibep
Solution for injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Solution for injection
Izokibep
Solution for injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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 participant 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ACELYRIN Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shephard Mpofu
Role: STUDY_DIRECTOR
ACELYRIN Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Research Site
Birmingham, Alabama, United States
Clinical Research Site
Scottsdale, Arizona, United States
Clinical Research Site
Scottsdale, Arizona, United States
Clinical Research Site
Fayetteville, Arkansas, United States
Clinical Research Site
Encino, California, United States
Clinical Research Site
Fountain Valley, California, United States
Clinical Research Site
Fremont, California, United States
Clinical Research Site
Los Angeles, California, United States
Clinical Research Site
Santa Monica, California, United States
Clinical Research Site
Boca Raton, Florida, United States
Clinical Research Site
Brandon, Florida, United States
Clinical Research Site
Coral Gables, Florida, United States
Clinical Research Site
Hollywood, Florida, United States
Clinical Research Site
Tampa, Florida, United States
Clinical Research Site
Tampa, Florida, United States
Clinical Research Site
Atlanta, Georgia, United States
Clinical Research Site
Sandy Springs, Georgia, United States
Clinical Research Site
Savannah, Georgia, United States
Clinical Research Site
Springfield, Illinois, United States
Clinical Research Site
Indianapolis, Indiana, United States
Clinical Research Site
Plainfield, Indiana, United States
Clinical Research Site
Topeka, Kansas, United States
Clinical Research Site
Murray, Kentucky, United States
Clinical Research Site
Baton Rouge, Louisiana, United States
Clinical Research Site
Baton Rouge, Louisiana, United States
Clinical Research Site
New Orleans, Louisiana, United States
Clinical Research Site
Largo, Maryland, United States
Clinical Research Site
Boston, Massachusetts, United States
Clinical Research Site
Canton, Michigan, United States
Clinical Research Site
Troy, Michigan, United States
Clinical Research Site
Lebanon, New Hampshire, United States
Clinical Research Site
New York, New York, United States
Clinical Research Site
Charlotte, North Carolina, United States
Clinical Research Site
Boardman, Ohio, United States
Clinical Research Site
Mason, Ohio, United States
Clinical Research Site
Springfield, Ohio, United States
Clinical Research Site
Portland, Oregon, United States
Clinical Research Site
Hershey, Pennsylvania, United States
Clinical Research Site
Pittsburgh, Pennsylvania, United States
Clinical Research Site
Sugarloaf, Pennsylvania, United States
Clinical Research Site
Thompson's Station, Tennessee, United States
Clinical Research Site
Arlington, Texas, United States
Clinical Research Site
Frisco, Texas, United States
Clinical Research Site
Pflugerville, Texas, United States
Clinical Research Site
San Antonio, Texas, United States
Clinical Research Site
The Woodlands, Texas, United States
Clinical Research Site
Webster, Texas, United States
Clinical Research Site
Springville, Utah, United States
Clinical Research Site
West Jordan, Utah, United States
Clinical Research Site
Charlottesville, Virginia, United States
Clinical Research Site
Edmonton, Alberta, Canada
Clinical Research Site
Edmonton, Alberta, Canada
Clinical Research Site
Winnipeg, Manitoba, Canada
Clinical Research Site
North Bay, Ontario, Canada
Clinical Research Site
Peterborough, Ontario, Canada
Clinical Research Site
Toronto, Ontario, Canada
Clinical Research Site
Toronto, Ontario, Canada
Clinical Research Site
Toronto, Ontario, Canada
Clinical Research Site
Waterloo, Ontario, Canada
Clinical Research Site
Saskatoon, Saskatchewan, Canada
Clinical Research Site
Dijon, Bourgogne-Franche-Comté, France
Clinical Research Site
Montpellier, Occitanie, France
Clinical Research Site
Nantes, Pays de la Loire Region, France
Clinical Research Site
Toulon, , France
Clinical Research Site
Darmstadt, Hesse, Germany
Clinical Research Site
Bad Bentheim, Lower Saxony, Germany
Clinical Research Site
Mainz, Rhineland-Palatinate, Germany
Clinical Research Site
Leipzig, Saxony, Germany
Clinical Research Site
Kiel, Schleswig-Holstein, Germany
Clinical Research Site
Debrecen, Hajdú-Bihar, Hungary
Clinical Research Site
Zalaegerszeg, Zala County, Hungary
Clinical Research Site
Budapest, , Hungary
Clinical Research Site
Fukuoka, Fukoka Prefecture, Japan
Clinical Research Site
Kitakyushu, Fukuoka, Japan
Clinical Research Site
Obihiro, Hokkaido Prefecture, Japan
Clinical Research Site
Sapporo, Hokkaido Prefecture, Japan
Clinical Research Site
Kawasaki, Kanagawa, Japan
Clinical Research Site
Yokohama, Kanagawa, Japan
Clinical Research Site
Kyoto, Kyoto, Japan
Clinical Research Site
Osaka, Osaka, Japan
Clinical Research Site
Shinjuku-Ku, Tokyo, Japan
Clinical Research Site
tabashi City, Tokyo, Japan
Clinical Research Site
Nishinomiya, , Japan
Clinical Research Site
Krakow, Lesser Poland Voivodeship, Poland
Clinical Research Site
Krakow, Lesser Poland Voivodeship, Poland
Clinical Research Site
Wroclaw, Lower Silesian Voivodeship, Poland
Clinical Research Site
Wroclaw, Lower Silesian Voivodeship, Poland
Clinical Research Site
Lublin, Lublin Voivodeship, Poland
Clinical Research Site
Katowice, Silesian Voivodeship, Poland
Clinical Research Site
Ożarowice, Silesian Voivodeship, Poland
Clinical Research Site
Sosnowiec, Silesian Voivodeship, Poland
Clinical Research Site
Lodz, Łódź Voivodeship, Poland
Clinical Research Site
Seville, Andalusia, Spain
Clinical Research Site
Palma de Mallorca, Balearic Islands, Spain
Clinical Research Site
Badalona, Catalonia, Spain
Clinical Research Site
Barcelona, Catalonia, Spain
Clinical Research Site
Manises, Valencia, Spain
Clinical Research Site
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-503160-33-00
Identifier Type: OTHER
Identifier Source: secondary_id
22107
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.