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Completed

NCT Number: NCT06603077

A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa

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).

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Site 1203, Darlinghurst, New South Wales, Australia

Loading trial locations.

About this study

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:

  • A Screening Period which will last up to 28 days.
  • A Treatment Period up to 16 weeks.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior to Screening.
  • 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

  • Has a draining fistula count of ≥ 20.
  • 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.
  • 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).
  • Has severe, progressive and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or immunosuppressive disease.

Treatment and study plan

AVTX-009 Regimen 1

Drug

AVTX-009 will be administered as a subcutaneous injection every 4 weeks.

AVTX-009 Regimen 2

Drug

AVTX-009 will be administered as a subcutaneous injection every 2 weeks.

Placebo

Drug

Matching placebo will be administered as a subcutaneous injection every 2 weeks.

Primary outcomes

  1. Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

    Time frame: 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 outcomes

  1. Proportion of patients achieving HiSCR50

    Time frame: 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.

  2. Proportion of patients achieving HiSCR90

    Time frame: 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.

  3. Change from Baseline in International HS Severity Score System (IHS4)

    Time frame: 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.

  4. Change from Baseline in total abscess and inflammatory nodule (AN) count

    Time frame: 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.

  5. Change from Baseline in draining fistula count

    Time frame: 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.

  6. 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)

    Time frame: 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).

  7. Percentage of patients with flares

    Time frame: 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.

  8. AVTX-009 anti-drug antibodies (ADA)

    Time frame: From Baseline (Day 1) to Week 20

    The incidence of patients with AVTX-009 anti-drug antibodies (ADA).

  9. Safety and tolerability of AVTX-009

    Time frame: From Baseline (Day 1) to Week 20

    Incidence of adverse events (AEs).

Sponsors and collaborators

Lead sponsor

Avalo Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa (LOTUS)

Acronym: LOTUS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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