Hidradenitis Suppurativa
Conditions
Keywords
Hidradenitis Suppurativa, HS, acne inversa, AVTX-009, LY2189102, FL-101
Brief summary
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).
Detailed description
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.
Interventions
DRUGAVTX-009 Regimen 1
AVTX-009 will be administered as a subcutaneous injection every 4 weeks.
DRUGAVTX-009 Regimen 2
AVTX-009 will be administered as a subcutaneous injection every 2 weeks.
DRUGPlacebo
Matching placebo will be administered as a subcutaneous injection every 2 weeks.
Sponsors
Avalo Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior to Screening. 2. At least 5 inflammatory lesions in at least 2 distinct anatomical areas, at least 1 of which is Hurley Stage 2 or 3.
Exclusion criteria
1. Has a draining fistula count of ≥ 20. 2. Has another active skin inflammatory condition, infection (viral, bacterial, or fungal), or another active ongoing inflammatory disease (other than HS) that requires treatment with a prohibited medication, which could interfere with the assessment of HS. 3. History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic lung infection, recurrent urinary tract infection, or open, draining or infected skin wounds or ulcers (not related to HS). 4. Has severe, progressive and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or immunosuppressive disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) | At Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving HiSCR50 | At Week 16 | 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. |
| Proportion of patients achieving HiSCR90 | At Week 16 | 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. |
| Change from Baseline in International HS Severity Score System (IHS4) | Baseline (Day 1) and Week 16 | 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. |
| Change from Baseline in total abscess and inflammatory nodule (AN) count | Baseline (Day 1) and Week 16 | 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. |
| Change from Baseline in draining fistula count | Baseline (Day 1) and Week 16 | 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. |
| 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) | Baseline (Day 1) and Week 16 | 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). |
| Percentage of patients with flares | From Baseline (Day 1) to Week 16 | 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. |
| AVTX-009 anti-drug antibodies (ADA) | From Baseline (Day 1) to Week 20 | The incidence of patients with AVTX-009 anti-drug antibodies (ADA). |
| Safety and tolerability of AVTX-009 | From Baseline (Day 1) to Week 20 | Incidence of adverse events (AEs). |
Countries
Australia, Bulgaria, Canada, Czechia, France, Germany, Greece, Italy, Poland, Slovakia, Spain, Turkey (Türkiye), United States
Outcome results
None listed