Clinical trial NCT05355805: Hidradenitis Suppurativa Phase 2b Study of Izokibep
Official title: A Phase 2b Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: hidradenitis suppurativa
Izokibep
Lead sponsor: ACELYRIN Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-02
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Part A: Number of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12
timeFrame: Part A: Baseline to Week 12
measure: Part B: Number of Participants Who Achieved HiSCR75 at Week 16
timeFrame: Part B: Baseline to Week 16
Secondary outcomes:
measure: Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks
measure: Part A: Number of Participants Testing Positive for Anti-drug Antibodies (ADAs)
timeFrame: Baseline, Week 16, Week 32, Week 39
measure: Part B: Number of Participants Who Achieved HiSCR90 at Week 16
timeFrame: Part B: Baseline to Week 16
measure: Part B: Number of Participants Who Achieved HiSCR100 at Week 16
timeFrame: Part B: Baseline to Week 16
measure: Part B: Number of Participants Who Achieved HiSCR50 at Week 16
timeFrame: Part B: Baseline to Week 16
measure: Part B: Percentage of Participants Who Experienced ≥ 1 Disease Flare Through 16 Weeks of Treatment
timeFrame: Part B: Day 1 through to Week 16
measure: Part B: Number of Participants With Hurley Stage II at Baseline Who Achieved AN Count of 0, 1, or 2
timeFrame: Part B: Week 16
measure: 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
timeFrame: Part B: Baseline to Week 16
measure: Part B: Number of Participants With TEAEs of Special Interest
timeFrame: Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks
measure: Part B: Number of Participants With TEAEs
timeFrame: Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks
measure: Part B: Number of Participants Testing Positive for ADAs
timeFrame: Up to 39 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Site
state: Alabama
city: Encino
country: United States
facility: Clinical Research Site
state: California
city: Fountain Valley
country: United States
facility: Clinical Research Site
state: California
city: Los Angeles
country: United States
facility: Clinical Research Site
state: California
city: Los Angeles
country: United States
facility: Clinical Research Site
state: California
city: Ocala
country: United States
facility: Clinical Research Site
state: Florida
city: Tampa
country: United States
facility: Clinical Research Site
state: Florida
city: Sandy Springs
country: United States
facility: Clinical Research Site
state: Georgia
city: Savannah
country: United States
facility: Clinical Research Site
state: Georgia
city: Rolling Meadows
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: Murray
country: United States
facility: Clinical Research Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Clinical Research Site
state: Louisiana
city: New York
country: United States
facility: Clinical Research Site
state: New York
city: Mason
country: United States
facility: Clinical Research Site
state: Ohio
city: Portland
country: United States
facility: Clinical Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Webster
country: United States
facility: Clinical Research Site
state: Texas
city: London
country: Canada
facility: Clinical Research Site
state: Ontario
city: Markham
country: Canada
facility: Clinical Research Site
state: Ontario
city: Waterloo
country: Canada
facility: Clinical Research Site
state: Ontario
city: Québec
country: Canada
facility: Clinical Research Site
state: Quebec
city: Saskatoon
country: Canada
facility: Clinical Research Site
state: Saskatchewan
city: Bad Bentheim
country: Germany
facility: Clinical Research Site
state: NI
city: Bochum
country: Germany
facility: Clinical Research Site
state: Northwest
city: Kiel
country: Germany
facility: Clinical Research Site
state: SH
city: Kiel
country: Germany
facility: Clinical Research Site
state: SH
city: Schwerin
country: Germany
facility: Clinical Research Site
city: Budapest
country: Hungary
facility: Clinical Research Site
state: BU
city: Debrecen
country: Hungary
facility: Clinical Research Site
state: HB
city: Wrocław
country: Poland
facility: Clinical Research Site
state: DS
city: Wrocław
country: Poland
facility: Clinical Research Site
state: DS
city: Krakow
country: Poland
facility: Clinical Research Site
state: MA
city: Kraków
country: Poland
facility: Clinical Research Site
state: MA
city: Bialystok
country: Poland
facility: Clinical Research Site
state: PD
city: Katowice
country: Poland
facility: Clinical Research Site
state: SL
city: Lublin
country: Poland
facility: Clinical Research Site
city: Szczecin
country: Poland
facility: Clinical Research Site
city: Palma De Mallorca
country: Spain
facility: Clinical Research Site
state: PM
city: Pontevedra
country: Spain
facility: Clinical Research Site
state: PO
city: Manises
country: Spain
facility: Clinical Research Site
state: V
city: Barcelona
country: Spain
facility: Clinical Research Site
Study officials:
affiliation: ACELYRIN Inc.
name: Donald Betah, MD
role: STUDY_DIRECTOR
References: