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Hidradenitis Suppurativa Study of Izokibep

Primary Purpose

Hidradenitis Suppurativa

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Izokibep
Sponsored by
ACELYRIN Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Group 1: Placebo subcutaneous once weekly

Group 2: Izokibep subcutaneous once weekly

Arm Description

Participants will receive placebo every week to week 15, then izokibep to week 51.

Participants will receive izokibep every week to week 51

Outcomes

Primary Outcome Measures

Percentage of subjects achieving HiSCR75

Secondary Outcome Measures

Percentage of subjects achieving HiSCR90
Percentage of subjects achieving HiSCR100
Percentage of subjects achieving HiSCR50
Percentage of subjects that experience ≥ 1 disease flare
Change in Dermatology Life Quality Index (DLQI)
Percentage of subjects with baseline Hurley Stage II who achieve Abscess and Inflammatory Nodule (AN) count of 0, 1, or 2
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
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of events of interest
Incidence of serious adverse events (SAEs)
Incidence of clinically significant changes in laboratory values
Incidence of clinically significant change in vital signs

Full Information

First Posted
June 7, 2023
Last Updated
October 19, 2023
Sponsor
ACELYRIN Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05905783
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2023 (Actual)
Primary Completion Date
June 14, 2025 (Anticipated)
Study Completion Date
December 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACELYRIN Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Placebo subcutaneous once weekly
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo every week to week 15, then izokibep to week 51.
Arm Title
Group 2: Izokibep subcutaneous once weekly
Arm Type
Experimental
Arm Description
Participants will receive izokibep every week to week 51
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Form: Solution for injection Route of administration: Subcutaneous (SC)
Intervention Type
Drug
Intervention Name(s)
Izokibep
Intervention Description
Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)
Primary Outcome Measure Information:
Title
Percentage of subjects achieving HiSCR75
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of subjects achieving HiSCR90
Time Frame
Week 16
Title
Percentage of subjects achieving HiSCR100
Time Frame
Week 16
Title
Percentage of subjects achieving HiSCR50
Time Frame
Week 16
Title
Percentage of subjects that experience ≥ 1 disease flare
Time Frame
Up to Week 16
Title
Change in Dermatology Life Quality Index (DLQI)
Time Frame
Baseline to Week 16
Title
Percentage of subjects with baseline Hurley Stage II who achieve Abscess and Inflammatory Nodule (AN) count of 0, 1, or 2
Time Frame
Week 16
Title
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
Time Frame
Week 16
Title
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame
Day 1 to Follow-up (Week 59)
Title
Incidence of events of interest
Time Frame
Screening (Day -28) to Follow-up (Week 59)
Title
Incidence of serious adverse events (SAEs)
Time Frame
Screening (Day -28) to Follow-up (Week 59)
Title
Incidence of clinically significant changes in laboratory values
Time Frame
Screening (Day -28) to Follow-up (Week 59)
Title
Incidence of clinically significant change in vital signs
Time Frame
Screening (Day -28) to Follow-up (Week 59)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amol P. Kamboj, MD
Phone
805-730-0327
Email
clinicaltrials@acelyrin.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amol P. Kamboj, MD
Organizational Affiliation
ACELYRIN Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30315
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31419
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66614
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Murray
State/Province
Kentucky
ZIP/Postal Code
42071
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Canton
State/Province
Michigan
ZIP/Postal Code
48187
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18249
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Thompson's Station
State/Province
Tennessee
ZIP/Postal Code
37179
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J5K2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J1C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K2C1
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Hidradenitis Suppurativa Study of Izokibep

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