Hidradenitis Suppurativa Study of Izokibep

Hidradenitis Suppurativa Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05905783
• Other study ID #: 22107
• Secondary ID: 2022-503160-33-0
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 22, 2023
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: ACELYRIN Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 258
• Est. completion date: May 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• Placebo
Form: Solution for injection Route of administration: Subcutaneous (SC)
• Izokibep
Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)

Locations

Country	Name	City	State
Canada	Clinical Research Site	Edmonton	Alberta
Canada	Clinical Research Site	Edmonton	Alberta
Canada	Clinical Research Site	North Bay	Ontario
Canada	Clinical Research Site	Peterborough	Ontario
Canada	Clinical Research Site	Saskatoon	Saskatchewan
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	Winnipeg	Manitoba
France	Clinical Research Site	Dijon	Bourgogne-Franche-Comté
France	Clinical Research Site	Montpellier	Occitanie
France	Clinical Research Site	Nantes	Pays De La Loire
France	Clinical Research Site	Toulon	Provence-Alpes-Côte d'Azur
Germany	Clinical Research Site	Bad Bentheim	Lower Saxony
Germany	Clinical Research Site	Darmstadt	Hessen
Germany	Clinical Research Site	Kiel	Schleswig-Holstein
Germany	Clinical Research Site	Leipzig	Saxony
Germany	Clinical Research Site	Mainz	Rhineland-Palatinate
Hungary	Clinical Research Site	Budapest
Hungary	Clinical Research Site	Debrecen	Hajdú-Bihar
Hungary	Clinical Research Site	Zalaegerszeg	Zala
Japan	Clinical Research Site	Fukuoka	Fukoka Prefecture
Japan	Clinical Research Site	Itabashi	Tokyo Prefecture
Japan	Clinical Research Site	Kawasaki	Kanagawa Prefecture
Japan	Clinical Research Site	Kitakyushu	Fukuoka
Japan	Clinical Research Site	Kyoto	Kyoto Prefecture
Japan	Clinical Research Site	Nishinomiya
Japan	Clinical Research Site	Obihiro	Hokkaido Prefecture
Japan	Clinical Research Site	Osaka	Osaka Prefecture
Japan	Clinical Research Site	Sapporo	Hokkaido Prefecture
Japan	Clinical Research Site	Shinjuku-Ku	Tokyo Prefecture
Japan	Clinical Research Site	Yokohama	Kanagawa Prefecture
Poland	Clinical Research Site	Katowice	Silesian Voivodeship
Poland	Clinical Research Site	Kraków	Lesser Poland Voivodeship
Poland	Clinical Research Site	Kraków	Lesser Poland Voivodeship
Poland	Clinical Research Site	Lódz	Lódz Voivodeship
Poland	Clinical Research Site	Lublin	Lublin Voivodeship
Poland	Clinical Research Site	Ozarowice	Silesian Voivodeship
Poland	Clinical Research Site	Sosnowiec	Silesian Voivodeship
Poland	Clinical Research Site	Wroclaw	Lower Silesian Voivodeship
Poland	Clinical Research Site	Wroclaw	Lower Silesian Voivodeship
Spain	Clinical Research Site	Badalona	Catalonia
Spain	Clinical Research Site	Barcelona	Catalonia
Spain	Clinical Research Site	Madrid
Spain	Clinical Research Site	Manises	Valencia
Spain	Clinical Research Site	Palma De Mallorca	Illes Balears
Spain	Clinical Research Site	Sevilla	Andalusia
United States	Clinical Research Site	Arlington	Texas
United States	Clinical Research Site	Atlanta	Georgia
United States	Clinical Research Site	Baton Rouge	Louisiana
United States	Clinical Research Site	Baton Rouge	Louisiana
United States	Clinical Research Site	Birmingham	Alabama
United States	Clinical Research Site	Boardman	Ohio
United States	Clinical Research Site	Boca Raton	Florida
United States	Clinical Research Site	Boston	Massachusetts
United States	Clinical Research Site	Brandon	Florida
United States	Clinical Research Site	Canton	Michigan
United States	Clinical Research Site	Charlotte	North Carolina
United States	Clinical Research Site	Charlottesville	Virginia
United States	Clinical Research Site	Coral Gables	Florida
United States	Clinical Research Site	Encino	California
United States	Clinical Research Site	Fayetteville	Arkansas
United States	Clinical Research Site	Fountain Valley	California
United States	Clinical Research Site	Fremont	California
United States	Clinical Research Site	Frisco	Texas
United States	Clinical Research Site	Hershey	Pennsylvania
United States	Clinical Research Site	Hollywood	Florida
United States	Clinical Research Site	Indianapolis	Indiana
United States	Clinical Research Site	Largo	Maryland
United States	Clinical Research Site	Lebanon	New Hampshire
United States	Clinical Research Site	Los Angeles	California
United States	Clinical Research Site	Mason	Ohio
United States	Clinical Research Site	Murray	Kentucky
United States	Clinical Research Site	New Orleans	Louisiana
United States	Clinical Research Site	New York	New York
United States	Clinical Research Site	Pflugerville	Texas
United States	Clinical Research Site	Pittsburgh	Pennsylvania
United States	Clinical Research Site	Plainfield	Indiana
United States	Clinical Research Site	Portland	Oregon
United States	Clinical Research Site	San Antonio	Texas
United States	Clinical Research Site	Sandy Springs	Georgia
United States	Clinical Research Site	Santa Monica	California
United States	Clinical Research Site	Savannah	Georgia
United States	Clinical Research Site	Scottsdale	Arizona
United States	Clinical Research Site	Scottsdale	Arizona
United States	Clinical Research Site	Springfield	Illinois
United States	Clinical Research Site	Springfield	Ohio
United States	Clinical Research Site	Springville	Utah
United States	Clinical Research Site	Sugarloaf	Pennsylvania
United States	Clinical Research Site	Tampa	Florida
United States	Clinical Research Site	Tampa	Florida
United States	Clinical Research Site	The Woodlands	Texas
United States	Clinical Research Site	Thompson's Station	Tennessee
United States	Clinical Research Site	Topeka	Kansas
United States	Clinical Research Site	Troy	Michigan
United States	Clinical Research Site	Webster	Texas
United States	Clinical Research Site	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
ACELYRIN Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Hungary,  Japan,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects achieving HiSCR75		Week 16
Secondary	Percentage of subjects achieving HiSCR90		Week 16
Secondary	Percentage of subjects achieving HiSCR100		Week 16
Secondary	Percentage of subjects achieving HiSCR50		Week 16
Secondary	Percentage of subjects that experience = 1 disease flare		Up to Week 16
Secondary	Change in Dermatology Life Quality Index (DLQI)		Baseline to Week 16
Secondary	Percentage of subjects with baseline Hurley Stage II who achieve Abscess and Inflammatory Nodule (AN) count of 0, 1, or 2		Week 16
Secondary	Percentage of subjects achieving at least 3 point reduction from baseline in Numeric Rating Scale (NRS) Patient Global Assessment of Skin Pain at its worst among subjects with baseline NRS = 4		Week 16
Secondary	Incidence of treatment-emergent adverse events (TEAEs)		Day 1 to Follow-up (Week 59)
Secondary	Incidence of events of interest		Screening (Day -28) to Follow-up (Week 59)
Secondary	Incidence of serious adverse events (SAEs)		Screening (Day -28) to Follow-up (Week 59)
Secondary	Incidence of clinically significant changes in laboratory values		Screening (Day -28) to Follow-up (Week 59)
Secondary	Incidence of clinically significant change in vital signs		Screening (Day -28) to Follow-up (Week 59)