The main purpose of this study is to evaluate the efficacy and safety of AVTX-009 compared with placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).
This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study. Patients will be randomized to one of two AVTX-009 dose regimens or matching placebo in a 1:1:1 ratio. The study will comprise: 1. A Screening Period which will last up to 28 days. 2. A Treatment Period up to 16 weeks. 3. A Follow-up period of 6 weeks after the last dose of study drug. The maximum clinical trial duration for each participant is 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
AVTX-009 will be administered as a subcutaneous injection every 4 weeks.
AVTX-009 will be administered as a subcutaneous injection every 2 weeks.
Matching placebo will be administered as a subcutaneous injection every 2 weeks.
Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
HiSCR75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count, relative to Baseline.
Time frame: At Week 16
Proportion of patients achieving HiSCR50
HiSCR50 is defined as at least a 50% reduction in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count, relative to Baseline.
Time frame: At Week 16
Proportion of patients achieving HiSCR90
HiSCR90 is defined as at least a 90% reduction in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count, relative to Baseline.
Time frame: At Week 16
Change from Baseline in International HS Severity Score System (IHS4)
IHS4 score is calculated by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild disease, 4 to 10 signifies moderate disease, and 11 or higher signifies severe disease.
Time frame: Baseline (Day 1) and Week 16
Change from Baseline in total abscess and inflammatory nodule (AN) count
An abscess is a circumscribed collection of purulent exudates frequently associated with swelling, erythema, and other signs of inflammation, such as fluctuance, tenderness, and pain. An inflammatory nodule is a raised, deep-seated, three-dimensional, round nodule, greater than 10 mm in diameter. It is tender and erythematous without evidence of fluctuance.
Time frame: Baseline (Day 1) and Week 16
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Clinical Site 1022
Scottsdale, Arizona, United States
Clinical Site 1037
Scottsdale, Arizona, United States
Clinical Site 1026
Tucson, Arizona, United States
Clinical Site 1032
Northridge, California, United States
Clinical Site 1019
Pomona, California, United States
Clinical Site 1009
Sacramento, California, United States
Clinical Site 1034
Santa Monica, California, United States
Clinical Site 1011
Washington D.C., District of Columbia, United States
Clinical Site 1029
Boca Raton, Florida, United States
Clinical Site 1002
Coral Gables, Florida, United States
...and 79 more locations
Change from Baseline in draining fistula count
Draining fistula is defined as a pathologic passageway connecting to the skin surface from dermis or subcutaneous tissue that drains serous or purulent fluid, either spontaneously or by gentle palpation.
Time frame: Baseline (Day 1) and Week 16
Percentage of patients achieving at least a 30% reduction and at least a 1-unit reduction from Baseline on a Numerical Rating Scale (NRS) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3 (NRS30)
The skin pain NRS is a single-item measure to capture the patient's self-reported skin pain severity by rating the worst level of skin pain in the last 24 hours as a number on a numerical rating scale from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Baseline (Day 1) and Week 16
Percentage of patients with flares
The number of patients with flares will be programmatically calculated based on the assessed lesion counts. A flare is defined as ≥ 25% increase in AN count plus an increase of ≥ 2 in AN count compared to Baseline.
Time frame: From Baseline (Day 1) to Week 16
AVTX-009 anti-drug antibodies (ADA)
The incidence of patients with AVTX-009 anti-drug antibodies (ADA).
Time frame: From Baseline (Day 1) to Week 20
Safety and tolerability of AVTX-009
Incidence of adverse events (AEs).
Time frame: From Baseline (Day 1) to Week 20