Hidradenitis Suppurativa Study of Izokibep
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Group 1: Placebo subcutaneous once weekly Participants will receive placebo every week to week 15, then izokibep to week 51. |
Drug: Placebo
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Drug: Izokibep
Biologic: IL-17A inhibitor
Form: Solution for injection
Route of administration: Subcutaneous (SC)
|
| Experimental: Group 2: Izokibep subcutaneous once weekly Participants will receive izokibep every week to week 51 |
Drug: Izokibep
Biologic: IL-17A inhibitor
Form: Solution for injection
Route of administration: Subcutaneous (SC)
|
Outcome Measures
Primary Outcome Measures
- Percentage of subjects achieving HiSCR75 [Week 16]
Secondary Outcome Measures
- Percentage of subjects achieving HiSCR90 [Week 16]
- Percentage of subjects achieving HiSCR100 [Week 16]
- Percentage of subjects achieving HiSCR50 [Week 16]
- Percentage of subjects that experience ≥ 1 disease flare [Up to Week 16]
- Change in Dermatology Life Quality Index (DLQI) [Baseline to Week 16]
- Percentage of subjects with baseline Hurley Stage II who achieve Abscess and Inflammatory Nodule (AN) count of 0, 1, or 2 [Week 16]
- 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]
- Incidence of treatment-emergent adverse events (TEAEs) [Day 1 to Follow-up (Week 59)]
- Incidence of events of interest [Screening (Day -28) to Follow-up (Week 59)]
- Incidence of serious adverse events (SAEs) [Screening (Day -28) to Follow-up (Week 59)]
- Incidence of clinically significant changes in laboratory values [Screening (Day -28) to Follow-up (Week 59)]
- Incidence of clinically significant change in vital signs [Screening (Day -28) to Follow-up (Week 59)]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Site | Tampa | Florida | United States | 33613 |
| 2 | Clinical Research Site | Baton Rouge | Louisiana | United States | 70808 |
Sponsors and Collaborators
- ACELYRIN Inc.
Investigators
- Study Director: Amol P. Kamboj, MD, ACELYRIN Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22107
- 2022-503160-33-00