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AVTX-009

Researchers are currently investigating AVTX-009, a promising new medication for people suffering from moderate to severe Hidradenitis Suppurativa (HS). The LOTUS study is a Phase 2 clinical trial designed to evaluate how effectively and safely AVTX-009 works compared to a placebo. This randomized trial involves different dosing schedules of AVTX-009 administered as subcutaneous injections. Participants will receive treatment for up to 16 weeks, with researchers monitoring improvements in HS symptoms such as reduction in abscesses, inflammatory nodules, and draining fistulas. This trial represents an important step in developing new treatment options for this challenging skin condition.

Table of Contents

What is AVTX-009?

AVTX-009 is an investigational drug that is currently being studied for the treatment of moderate to severe Hidradenitis Suppurativa (HS). It is being evaluated in a clinical trial to determine if it can safely and effectively treat the symptoms of this painful skin condition. The drug is administered through subcutaneous injection, which means it is injected under the skin.[1]

While the specific mechanism of how AVTX-009 works is not detailed in the available information, it is being studied as a potential treatment option for patients who suffer from HS, a chronic inflammatory skin condition. The trial aims to compare AVTX-009 against a placebo to determine its effectiveness and safety profile.[1]

What is Hidradenitis Suppurativa?

Hidradenitis Suppurativa (HS) is a chronic, inflammatory skin condition characterized by painful bumps that appear in areas where skin rubs together, such as the armpits, groin, buttocks, and under the breasts. These bumps can become very painful and may break open, releasing fluid and developing into tunnels under the skin.[1]

The severity of HS can be classified as follows:

  • Mild: Total International HS Severity Score System (IHS4) score of 3 or less
  • Moderate: IHS4 score of 4 to 10
  • Severe: IHS4 score of 11 or higher

The IHS4 score is calculated by adding the number of nodules (multiplied by 1), the number of abscesses (multiplied by 2), and the number of draining tunnels (multiplied by 4).[1]

Clinical Trial Details

AVTX-009 is being evaluated in a Phase 2 clinical trial called LOTUS. This is a randomized, double-blind, placebo-controlled, parallel-group study. Let’s break down what these terms mean:[1]

  • Phase 2: This phase of clinical research focuses on determining the effectiveness of a drug for a specific medical condition and continues to evaluate its safety.
  • Randomized: Participants are randomly assigned to receive either AVTX-009 or a placebo.
  • Double-blind: Neither the participants nor the researchers know who is receiving the actual drug versus the placebo during the study.
  • Placebo-controlled: Some participants receive a placebo (an inactive substance) instead of the study drug to compare outcomes.
  • Parallel-group: Different groups of participants receive different treatments simultaneously.

The trial consists of three parts:[1]

  1. A Screening Period lasting up to 28 days to determine eligibility
  2. A Treatment Period of up to 16 weeks
  3. A Follow-up Period of 6 weeks after the last dose

The maximum duration of participation in the trial is 24 weeks. Participants are randomly assigned in a 1:1:1 ratio to one of three groups:[1]

  • AVTX-009 Regimen 1
  • AVTX-009 Regimen 2
  • Matching placebo

How is AVTX-009 Administered?

In the clinical trial, AVTX-009 is administered in two different regimens:[1]

  • Regimen 1: AVTX-009 is given as a subcutaneous injection (an injection under the skin) every 4 weeks.
  • Regimen 2: AVTX-009 is given as a subcutaneous injection every 2 weeks.

The placebo group receives matching placebo injections every 2 weeks. These different dosing schedules will help researchers determine the most effective and safe dosing regimen for AVTX-009.[1]

How is the Effectiveness of AVTX-009 Being Measured?

The clinical trial uses several measurements to evaluate how well AVTX-009 works for treating HS. The primary measurement is:[1]

Hidradenitis Suppurativa Clinical Response 75 (HiSCR75): This 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, compared to the beginning of the study (baseline).[1]

Additional measurements include:

  • HiSCR50: At least a 50% reduction in total abscess and inflammatory nodule count, with no increase in abscess or draining fistula counts.[1]
  • HiSCR90: At least a 90% reduction in total abscess and inflammatory nodule count, with no increase in abscess or draining fistula counts.[1]
  • Change from baseline in International HS Severity Score System (IHS4).[1]
  • Change from baseline in total abscess and inflammatory nodule (AN) count. An abscess is a collection of pus associated with swelling, redness, and other signs of inflammation. An inflammatory nodule is a raised, deep-seated, round bump, greater than 10 mm in diameter that is tender and red without evidence of containing fluid that can be drained.[1]
  • Change from baseline in draining fistula count. A draining fistula is a pathway connecting to the skin surface that drains fluid, either spontaneously or when gently pressed.[1]
  • Percentage of patients achieving at least a 30% reduction and at least a 1-unit reduction from baseline on the Numerical Rating Scale (NRS) in Patient’s Global Assessment of Skin Pain. This measures pain on a scale from 0 (no pain) to 10 (worst pain imaginable).[1]
  • Percentage of patients with flares, defined as a 25% or greater increase in abscess and inflammatory nodule count plus an increase of 2 or more compared to baseline.[1]

Safety Monitoring

The safety and tolerability of AVTX-009 are being closely monitored throughout the clinical trial. This includes:[1]

  • Tracking the incidence of adverse events (AEs), which are any unfavorable medical occurrences in a participant receiving the drug.
  • Monitoring for the development of anti-drug antibodies (ADA), which are antibodies that the body might produce against AVTX-009. The development of these antibodies could potentially affect how well the drug works or cause immune reactions.

Safety monitoring continues from the start of treatment through the 6-week follow-up period (up to Week 20).[1]

Study Aspect Details
Official Name LOTUS: 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
Study Type Phase 2 clinical trial
Treatment Groups 1. AVTX-009 Regimen 1 (subcutaneous injection every 4 weeks)
2. AVTX-009 Regimen 2 (subcutaneous injection every 2 weeks)
3. Placebo (subcutaneous injection every 2 weeks)
Study Duration Up to 24 weeks total (28-day screening, 16-week treatment, 6-week follow-up)
Primary Outcome Proportion of patients achieving HiSCR75 (75% reduction in inflammatory lesions)
Key Secondary Outcomes – HiSCR50 and HiSCR90 achievement rates
– Change in International HS Severity Score
– Reduction in abscess and inflammatory nodule counts
– Reduction in draining fistula counts
– Improvement in skin pain
– Percentage of patients with disease flares
Safety Assessments – Incidence of adverse events
– Development of anti-drug antibodies

FAQ

  • What is Hidradenitis Suppurativa (HS)? Hidradenitis Suppurativa (HS) is a chronic skin condition characterized by painful, swollen lumps that form under the skin, typically in areas where skin rubs together, such as the armpits, groin, and buttocks. These lumps can become infected and break open, releasing fluid and causing significant discomfort. HS ranges from mild to severe and can significantly impact quality of life.
  • How is AVTX-009 administered in the clinical trial? In the LOTUS clinical trial, AVTX-009 is administered as a subcutaneous injection (an injection under the skin). The trial is testing two different regimens: Regimen 1 involves injections every 4 weeks, while Regimen 2 involves injections every 2 weeks. Some participants will receive a placebo injection (which contains no active medication) every 2 weeks instead.
  • How long does the LOTUS clinical trial last? The maximum duration of the LOTUS clinical trial for each participant is 24 weeks. This includes a Screening Period of up to 28 days, a Treatment Period of up to 16 weeks, and a Follow-up period of 6 weeks after the last dose of the study drug.
  • How will researchers determine if AVTX-009 is working? Researchers will primarily look at the proportion of patients who achieve HiSCR75, which means at least a 75% reduction in the total number of abscesses and inflammatory nodules, with no increase in abscess count and no increase in draining fistula count compared to baseline. They will also measure other levels of improvement (HiSCR50 and HiSCR90), changes in disease severity scores, reduction in skin pain, and monitor for any disease flares.
  • What safety measures are included in the LOTUS trial? The trial includes several safety monitoring measures. Researchers will track all adverse events (side effects) that participants experience during the trial. They will also monitor for the development of anti-drug antibodies (ADAs), which are antibodies that the body might produce against AVTX-009. Safety assessments will continue during the 6-week follow-up period after the last dose.

Ongoing Clinical Trials on AVTX-009

  • Study on the Effectiveness of AVTX-009 for Treating Moderate to Severe Hidradenitis Suppurativa in Patients

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia France Germany Greece Italy +3

Glossary

  • Hidradenitis Suppurativa (HS): A chronic, inflammatory skin condition characterized by painful bumps, nodules, and abscesses that typically occur in areas where skin rubs together, such as armpits, groin, and buttocks.
  • AVTX-009: The investigational drug being studied in the LOTUS clinical trial for the treatment of moderate to severe Hidradenitis Suppurativa.
  • Phase 2 clinical trial: A stage of clinical research that evaluates the effectiveness of a drug and continues to monitor its safety in a larger group of patients. Phase 2 trials typically follow successful Phase 1 trials (which focus primarily on safety).
  • Randomized: A process in clinical trials where participants are assigned by chance to different treatment groups. This helps reduce bias in the study results.
  • Double-blind: A study design where neither the participants nor the researchers know which treatment a participant is receiving. This helps prevent bias in how treatments are given and how results are interpreted.
  • Placebo-controlled: A study that includes a group of participants who receive an inactive substance (placebo) that looks like the drug being tested but contains no active medication. This helps determine if the effects seen with the active drug are actually due to the drug itself.
  • Subcutaneous injection: An injection administered beneath the skin into the subcutaneous tissue (the layer of fat just below the skin).
  • HiSCR75: Hidradenitis Suppurativa Clinical Response 75 – 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, compared to baseline.
  • HiSCR50/HiSCR90: Similar to HiSCR75, but requiring at least a 50% or 90% reduction in abscess and inflammatory nodule count, respectively.
  • Abscess: A circumscribed collection of pus that forms due to infection and inflammation, frequently associated with swelling, redness, and pain.
  • Inflammatory nodule: A raised, deep-seated, three-dimensional, round bump greater than 10 mm in diameter that is tender and red without evidence of containing fluid that can be drained.
  • Draining fistula: An abnormal tunnel connecting the deeper skin layers to the skin surface that leaks fluid, either spontaneously or when gently pressed.
  • International HS Severity Score System (IHS4): A scoring system used to assess the severity of Hidradenitis Suppurativa. It's calculated by counting nodules (x1) plus abscesses (x2) plus draining tunnels (x4). Scores of 3 or less indicate mild disease, 4-10 indicate moderate disease, and 11 or higher indicate severe disease.
  • Numerical Rating Scale (NRS): A scale from 0 to 10 used by patients to rate their pain, where 0 represents no pain and 10 represents the worst pain imaginable.
  • Flare: In the context of this study, a flare is defined as at least a 25% increase in abscess and inflammatory nodule count plus an increase of at least 2 in this count compared to baseline. Flares represent worsening of the condition.
  • Anti-drug antibodies (ADA): Antibodies that the body produces against a therapeutic drug. These can potentially reduce the effectiveness of the drug or cause immune reactions.
  • Adverse events (AEs): Any undesirable experience or side effect that occurs during a clinical trial, whether or not it is related to the study drug.

References

  1. https://clinicaltrials.gov/study/NCT06603077