Phase 2
N=205
Hidradenitis Suppurativa Phase 2b Study of Izokibep
Hidradenitis Suppurativa
Bottom Line
View on ClinicalTrials.gov: NCT05355805 ↗Enrolled (actual)
205
Serious AEs
3.1%
Results posted
Sep 2024
Primary outcome: Primary: Part A: Number of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12 — 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Izokibep (Drug); Placebo to izokibep (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ACELYRIN Inc.
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Number of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12 |
12 | — |
| PRIMARY Part B: Number of Participants Who Achieved HiSCR75 at Week 16 |
16; 21; 19 | 0.3055 |
| SECONDARY Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
26; 2 | — |
| SECONDARY Part A: Number of Participants Testing Positive for Anti-drug Antibodies (ADAs) |
12; 11; 15; 17 | — |
| SECONDARY Part B: Number of Participants Who Achieved HiSCR90 at Week 16 |
9; 15; 12 | 0.1606 |
| SECONDARY Part B: Number of Participants Who Achieved HiSCR100 at Week 16 |
7; 15; 11 | 0.0514 |
| SECONDARY Part B: Number of Participants Who Achieved HiSCR50 at Week 16 |
22; 26; 26 | 0.3258 |
| SECONDARY Part B: Percentage of Participants Who Experienced ≥ 1 Disease Flare Through 16 Weeks of Treatment |
22.32; 18.29; 14.93 | 0.3329 |
| SECONDARY Part B: Number of Participants With Hurley Stage II at Baseline Who Achieved AN Count of 0, 1, or 2 |
15; 18; 14 | 0.5422 |
| SECONDARY 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 |
4; 5; 9 | 0.4031 |
| SECONDARY Part B: Number of Participants With TEAEs of Special Interest |
4; 2; 1; 1; 2; 0 | — |
| SECONDARY Part B: Number of Participants With TEAEs |
40; 49; 48; 17; 16; 27 | — |
| SECONDARY Part B: Number of Participants Testing Positive for ADAs |
27; 29; 36; 21; 29; 39 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05355805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.