Hidradenitis Suppurativa Study of Izokibep

Phase 3

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group 1	Placebo	Participants will receive placebo as a subcutaneous (SC) injection every week (QW) from Day 1 to Week 15. Participants will then receive izokibep as a SC injection QW from Week 16 to Week 51.
Group 1	Izokibep	Participants will receive placebo as a subcutaneous (SC) injection every week (QW) from Day 1 to Week 15. Participants will then receive izokibep as a SC injection QW from Week 16 to Week 51.
Group 2	Izokibep	Participants will receive izokibep QW from Day 1 to Week 51.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving HiSCR75	Week 12

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving HiSCR90	Week 12
Percentage of Participants Achieving HiSCR100	Week 12
Percentage of Participants Achieving HiSCR50	Week 12
Percentage of Participants That Experience ≥ 1 Disease Flare	Up to Week 12
Change in Dermatology Life Quality Index (DLQI)	Baseline to Week 12
Percentage of Participants With Baseline Hurley Stage II Who Achieve Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2	Baseline and Week 12
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	Baseline and Week 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Day 1 to Week 55
Number of Participants With Treatment-emergent Events of Interest	Day 1 to Week 55
Number of Participant With Treatment-emergent Serious Adverse Events (TESAEs)	Day 1 to Week 55
Number of Participants With Clinically Significant Changes in Laboratory Values	Screening (Day -28) to Follow-up (Week 59)
Number of Participants With Clinically Significant Change in Vital Signs	Screening (Day -28) to Follow-up (Week 59)