Clinical trial NCT05905783: Hidradenitis Suppurativa Study of Izokibep
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hidradenitis Suppurativa
Lead sponsor: ACELYRIN Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

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

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 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)

Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants Achieving HiSCR75
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving HiSCR90
timeFrame: Week 12
measure: Percentage of Participants Achieving HiSCR100
timeFrame: Week 12
measure: Percentage of Participants Achieving HiSCR50
timeFrame: Week 12
measure: Percentage of Participants That Experience ≥ 1 Disease Flare
timeFrame: Up to Week 12
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline to Week 12
measure: Percentage of Participants With Baseline Hurley Stage II Who Achieve Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving at Least 3-point Reduction From Baseline in Numeric Rating Scale (NRS) Patient Global Assessment of Skin Pain at its Worst Among Participants With Baseline NRS ≥ 4
timeFrame: Baseline and Week 12
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Week 55
measure: Number of Participants With Treatment-emergent Events of Interest
timeFrame: Day 1 to Week 55
measure: Number of Participant With Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 to Week 55
measure: Number of Participants With Clinically Significant Changes in Laboratory Values
timeFrame: Screening (Day -28) to Follow-up (Week 59)
measure: Number of Participants With Clinically Significant Change in Vital Signs
timeFrame: Screening (Day -28) to Follow-up (Week 59)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Site
state: Alabama
city: Scottsdale
country: United States
facility: Clinical Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Clinical Research Site
state: Arizona
city: Fayetteville
country: United States
facility: Clinical Research Site
state: Arkansas
city: Encino
country: United States
facility: Clinical Research Site
state: California
city: Fountain Valley
country: United States
facility: Clinical Research Site
state: California
city: Fremont
country: United States
facility: Clinical Research Site
state: California
city: Los Angeles
country: United States
facility: Clinical Research Site
state: California
city: Santa Monica
country: United States
facility: Clinical Research Site
state: California
city: Boca Raton
country: United States
facility: Clinical Research Site
state: Florida
city: Brandon
country: United States
facility: Clinical Research Site
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research Site
state: Florida
city: Hollywood
country: United States
facility: Clinical Research Site
state: Florida
city: Tampa
country: United States
facility: Clinical Research Site
state: Florida
city: Tampa
country: United States
facility: Clinical Research Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Research Site
state: Georgia
city: Sandy Springs
country: United States
facility: Clinical Research Site
state: Georgia
city: Savannah
country: United States
facility: Clinical Research Site
state: Georgia
city: Springfield
country: United States
facility: Clinical Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Clinical Research Site
state: Indiana
city: Plainfield
country: United States
facility: Clinical Research Site
state: Indiana
city: Topeka
country: United States
facility: Clinical Research Site
state: Kansas
city: Murray
country: United States
facility: Clinical Research Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Clinical Research Site
state: Louisiana
city: Baton Rouge
country: United States
facility: Clinical Research Site
state: Louisiana
city: New Orleans
country: United States
facility: Clinical Research Site
state: Louisiana
city: Largo
country: United States
facility: Clinical Research Site
state: Maryland
city: Boston
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Canton
country: United States
facility: Clinical Research Site
state: Michigan
city: Troy
country: United States
facility: Clinical Research Site
state: Michigan
city: Lebanon
country: United States
facility: Clinical Research Site
state: New Hampshire
city: New York
country: United States
facility: Clinical Research Site
state: New York
city: Charlotte
country: United States
facility: Clinical Research Site
state: North Carolina
city: Boardman
country: United States
facility: Clinical Research Site
state: Ohio
city: Mason
country: United States
facility: Clinical Research Site
state: Ohio
city: Springfield
country: United States
facility: Clinical Research Site
state: Ohio
city: Portland
country: United States
facility: Clinical Research Site
state: Oregon
city: Hershey
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Sugarloaf
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Thompson's Station
country: United States
facility: Clinical Research Site
state: Tennessee
city: Arlington
country: United States
facility: Clinical Research Site
state: Texas
city: Frisco
country: United States
facility: Clinical Research Site
state: Texas
city: Pflugerville
country: United States
facility: Clinical Research Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Research Site
state: Texas
city: The Woodlands
country: United States
facility: Clinical Research Site
state: Texas
city: Webster
country: United States
facility: Clinical Research Site
state: Texas
city: Springville
country: United States
facility: Clinical Research Site
state: Utah
city: West Jordan
country: United States
facility: Clinical Research Site
state: Utah
city: Charlottesville
country: United States
facility: Clinical Research Site
state: Virginia
city: Edmonton
country: Canada
facility: Clinical Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Clinical Research Site
state: Alberta
city: Winnipeg
country: Canada
facility: Clinical Research Site
state: Manitoba
city: North Bay
country: Canada
facility: Clinical Research Site
state: Ontario
city: Peterborough
country: Canada
facility: Clinical Research Site
state: Ontario
city: Toronto
country: Canada
facility: Clinical Research Site
state: Ontario
city: Toronto
country: Canada
facility: Clinical Research Site
state: Ontario
city: Toronto
country: Canada
facility: Clinical Research Site
state: Ontario
city: Waterloo
country: Canada
facility: Clinical Research Site
state: Ontario
city: Saskatoon
country: Canada
facility: Clinical Research Site
state: Saskatchewan
city: Dijon
country: France
facility: Clinical Research Site
state: Bourgogne-Franche-Comté
city: Montpellier
country: France
facility: Clinical Research Site
state: Occitanie
city: Nantes
country: France
facility: Clinical Research Site
state: Pays De La Loire
city: Toulon
country: France
facility: Clinical Research Site
city: Darmstadt
country: Germany
facility: Clinical Research Site
state: Hessen
city: Bad Bentheim
country: Germany
facility: Clinical Research Site
state: Lower Saxony
city: Mainz
country: Germany
facility: Clinical Research Site
state: Rhineland-Palatinate
city: Leipzig
country: Germany
facility: Clinical Research Site
state: Saxony
city: Kiel
country: Germany
facility: Clinical Research Site
state: Schleswig-Holstein
city: Debrecen
country: Hungary
facility: Clinical Research Site
state: Hajdú-Bihar
city: Zalaegerszeg
country: Hungary
facility: Clinical Research Site
state: Zala
city: Budapest
country: Hungary
facility: Clinical Research Site
city: Fukuoka
country: Japan
facility: Clinical Research Site
state: Fukoka Prefecture
city: Kitakyushu
country: Japan
facility: Clinical Research Site
state: Fukuoka
city: Obihiro
country: Japan
facility: Clinical Research Site
state: Hokkaido Prefecture
city: Sapporo
country: Japan
facility: Clinical Research Site
state: Hokkaido Prefecture
city: Kawasaki
country: Japan
facility: Clinical Research Site
state: Kanagawa Prefecture
city: Yokohama
country: Japan
facility: Clinical Research Site
state: Kanagawa Prefecture
city: Kyoto
country: Japan
facility: Clinical Research Site
state: Kyoto Prefecture
city: Osaka
country: Japan
facility: Clinical Research Site
state: Osaka Prefecture
city: Itabashi
country: Japan
facility: Clinical Research Site
state: Tokyo Prefecture
city: Shinjuku-Ku
country: Japan
facility: Clinical Research Site
state: Tokyo Prefecture
city: Nishinomiya
country: Japan
facility: Clinical Research Site
city: Kraków
country: Poland
facility: Clinical Research Site
state: Lesser Poland Voivodeship
city: Kraków
country: Poland
facility: Clinical Research Site
state: Lesser Poland Voivodeship
city: Wrocław
country: Poland
facility: Clinical Research Site
state: Lower Silesian Voivodeship
city: Wrocław
country: Poland
facility: Clinical Research Site
state: Lower Silesian Voivodeship
city: Lublin
country: Poland
facility: Clinical Research Site
state: Lublin Voivodeship
city: Katowice
country: Poland
facility: Clinical Research Site
state: Silesian Voivodeship
city: Ożarowice
country: Poland
facility: Clinical Research Site
state: Silesian Voivodeship
city: Sosnowiec
country: Poland
facility: Clinical Research Site
state: Silesian Voivodeship
city: Łódź
country: Poland
facility: Clinical Research Site
state: Łódź Voivodeship
city: Sevilla
country: Spain
facility: Clinical Research Site
state: Andalusia
city: Badalona
country: Spain
facility: Clinical Research Site
state: Catalonia
city: Barcelona
country: Spain
facility: Clinical Research Site
state: Catalonia
city: Palma De Mallorca
country: Spain
facility: Clinical Research Site
state: Illes Balears
city: Manises
country: Spain
facility: Clinical Research Site
state: Valencia
city: Madrid
country: Spain
facility: Clinical Research Site
Study officials:
affiliation: ACELYRIN Inc.
name: Shephard Mpofu
role: STUDY_DIRECTOR
References: