Hidradenitis Suppurativa Phase 2b Pivotal Study of Izokibep

Hidradenitis Suppurativa Clinical Trial

Official title:

A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05355805
• Other study ID #: 21102
• Secondary ID: 2021-005713-13
• Status: Completed
• Phase: Phase 2
• Start date: May 5, 2022
• Est. completion date: February 21, 2024

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: February 21, 2024
• Est. primary completion date: August 2, 2023
• 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 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.

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

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

Locations

Country	Name	City	State
Canada	Clinical Research Site	London	Ontario
Canada	Clinical Research Site	Markham	Ontario
Canada	Clinical Research Site	Québec	Quebec
Canada	Clinical Research Site	Saskatoon	Saskatchewan
Canada	Clinical Research Site	Waterloo	Ontario
Germany	Clinical Research Site	Bad Bentheim	NI
Germany	Clinical Research Site	Bochum	Northwest
Germany	Clinical Research Site	Kiel	SH
Germany	Clinical Research Site	Kiel	SH
Germany	Clinical Research Site	Schwerin
Hungary	Clinical Research Site	Budapest	BU
Hungary	Clinical Research Site	Debrecen	HB
Poland	Clinical Research Site	Bialystok	PD
Poland	Clinical Research Site	Katowice	SL
Poland	Clinical Research Site	Krakow	MA
Poland	Clinical Research Site	Kraków	MA
Poland	Clinical Research Site	Lublin
Poland	Clinical Research Site	Szczecin
Poland	Clinical Research Site	Wroclaw	DS
Poland	Clinical Research Site	Wroclaw	DS
Spain	Clinical Research Site	Barcelona
Spain	Clinical Research Site	Manises	V
Spain	Clinical Research Site	Palma De Mallorca	PM
Spain	Clinical Research Site	Pontevedra	PO
United States	Clinical Research Site	Baton Rouge	Louisiana
United States	Clinical Research Site	Birmingham	Alabama
United States	Clinical Research Site	Encino	California
United States	Clinical Research Site	Fountain Valley	California
United States	Clinical Research Site	Indianapolis	Indiana
United States	Clinical Research Site	Los Angeles	California
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 York	New York
United States	Clinical Research Site	Ocala	Florida
United States	Clinical Research Site	Philadelphia	Pennsylvania
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	Rolling Meadows	Illinois
United States	Clinical Research Site	Sandy Springs	Georgia
United States	Clinical Research Site	Savannah	Georgia
United States	Clinical Research Site	Tampa	Florida
United States	Clinical Research Site	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ACELYRIN Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Hidradenitis suppurativa clinical response (HiSCR75)		Part A: Week 12
Primary	Part B: Hidradenitis suppurativa clinical response (HiSCR75)		Part B: Week 16
Secondary	Part A: Incidence of treatment-emergent adverse events (TEAEs)		Part A: Screening (Day -28) to Follow-up Week 39
Secondary	Part A: Incidence of serious adverse events (SAEs)		Part A: Screening (Day -28) to Follow-up Week 39
Secondary	Part A: Incidence of clinically significant changes in laboratory values		Part A: Screening (Day -28) to Follow-up Week 39
Secondary	Part A: Incidence of clinically significant changes in vital signs		Part A: Screening (Day -28) to Follow-up Week 39
Secondary	Part A: Laboratory data confirming presence of anti-drug antibodies at each planned collection timepoint	In patients treated with izokibep: the detection and characterization of antibodies to izokibep will be performed via assay.	Part A: Day 1, Weeks 4, 8, 12, 16, 24, 32 and at follow-up (Weeks 39 and 45)
Secondary	Part B: Percent of subjects achieving HiSCR90		Part B: Week 16
Secondary	Part B: Percent of subjects achieving HiSCR100		Part B: Week 16
Secondary	Part B: Percent of subjects achieving HiSCR50		Part B: Week 16
Secondary	Part B: Percentage of subjects who experience = 1 disease flare through 16 weeks of treatment		Part B: Day 1 through to Week 16
Secondary	Part B: Percent of subjects with Hurley Stage II at baseline who achieve Abscess and Inflammatory Nodule (AN) count of 0, 1, or 2		Part B: Week 16
Secondary	Part B: Percentage of subjects achieving at least 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		Part B: Week 16
Secondary	Part B: Incidence of treatment-emergent adverse events (TEAEs)		Part B: Screening (Day -28) to Follow-up (Week 39)
Secondary	Part B: Incidence of events of interest		Part B: Screening (Day -28) to Follow-up (Week 39)
Secondary	Part B: Incidence of serious adverse events (SAEs)		Part B: Screening (Day -28) to Follow-up (Week 39)
Secondary	Part B: Incidence of clinically significant changes in laboratory values		Part B: Screening (Day -28) to Follow-up (Week 39)
Secondary	Part B: Incidence of clinically significant changes in vital signs		Part B: Screening (Day -28) to Follow-up (Week 39)
Secondary	Part B: Laboratory data confirming presence of anti-drug antibodies at each planned collection timepoint	In patients treated with izokibep: the detection and characterization of antibodies to izokibep will be performed via assay.	Part B: Day 1, Weeks 4, 8, 12, 16, 24, 32 and at follow-up (Weeks 39 and 45)