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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a skin condition called Hidradenitis Suppurativa, which is a chronic inflammatory disease that causes painful lumps under the skin. The study will evaluate a treatment called AVTX-009, which is a solution for injection developed by Avalo Therapeutics. The purpose of the study is to assess how effective and safe AVTX-009 is for patients with moderate to severe forms of this condition.

Participants in the study will receive either the AVTX-009 treatment or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure the results are unbiased. The treatment will be administered through subcutaneous injections, which means it is injected under the skin. The study will last for a period of 16 weeks, during which the participants' response to the treatment will be closely monitored.

The main goal is to see if the treatment can reduce the number of painful lumps and improve the overall condition of the skin. Participants will be evaluated on their progress, and any side effects will be recorded to ensure the safety of the treatment. The study will also look at other factors, such as changes in skin pain and the presence of any antibodies against AVTX-009. This research aims to provide valuable information on a potential new treatment option for those suffering from Hidradenitis Suppurativa.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination to ensure there are no signs of tuberculosis (TB).

    A negative result from a QuantiFERON-TB Gold test or a tuberculin skin test is required, along with a negative chest radiograph.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is performed to document the current state of the condition, hidradenitis suppurativa (HS). This includes counting the number of abscesses and inflammatory nodules (AN) and assessing the severity of the condition.

  3. Step 3

    Treatment administration

    Participants are randomly assigned to receive either the study drug, AVTX-009, or a placebo. The medication is administered as a subcutaneous injection, which means it is injected under the skin.

    The frequency and dosage of the injections are determined by the study protocol and are administered over a specified period.

  4. Step 4

    Ongoing monitoring

    Regular monitoring is conducted to track the progress of the treatment. This includes checking for any side effects, changes in vital signs, and conducting physical examinations.

    Participants are required to maintain an electronic diary to record their symptoms and any changes they experience.

  5. Step 5

    Evaluation of treatment efficacy

    The primary goal is to assess the effectiveness of AVTX-009 by measuring the reduction in abscess and inflammatory nodule count. A successful outcome is defined as achieving a 75% reduction in these counts by week 16, without an increase in abscess or draining fistula counts.

    Secondary evaluations include measuring the incidence of adverse events and changes in the severity of the condition.

  6. Step 6

    Final assessment

    At the end of the treatment period, a final assessment is conducted to evaluate the overall impact of the treatment. This includes a comprehensive review of all collected data and a final physical examination.

Who can join the trial?

7 criteria

  • The person must be at least 18 years old at the time they agree to join the study.
  • The person must be able to understand and sign a form agreeing to participate in the study, follow the study rules, read and understand study questions, and use an electronic diary.
  • The person must have had signs and symptoms of **hidradenitis suppurativa (HS)**, a skin condition, for at least 6 months before the study starts, as determined by the study doctor.
  • The person's **HS** must be moderate or severe, which means having at least 5 inflamed areas on the skin and these areas must be in at least 2 different body parts, with at least one part being more advanced (Hurley Stage 2 or 3).
  • The person must meet certain criteria for **tuberculosis (TB)** screening, which includes having no history of TB, not being treated for TB, showing no signs of TB, having a negative TB test, and a clear chest X-ray or CT scan.
  • Women who can have children and are sexually active, as well as female partners of men who are not sterile, must use a highly effective birth control method for 28 days before starting the study, during the study, and for 14 weeks after the last dose of the study drug.
  • Participants must agree not to donate eggs or sperm for assisted reproduction during the study and for 14 weeks after the last dose of the study drug.

Who cannot join the trial?

4 criteria

  • Patients who do not have moderate to severe hidradenitis suppurativa (HS) cannot participate. HS is a skin condition that causes small, painful lumps under the skin.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined in the study details.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are usually detailed in the study's guidelines.
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Investigated drugs

AVTX-009 is an investigational medication being studied for its potential to treat moderate to severe hidradenitis suppurativa, a chronic skin condition characterized by painful lumps under the skin. The trial aims to assess how effective and safe this medication is for patients suffering from this condition.

What is already known about the treatment

AVTX-009 – AVTX-009 is administered as an injection, typically under the skin. It is currently being studied in clinical trials for its effectiveness in treating moderate to severe hidradenitis suppurativa, a chronic skin condition. The medication is in the experimental phase and is not yet widely available in medical practice. It works by targeting specific molecules involved in the inflammatory process, aiming to reduce inflammation and symptoms associated with the condition. AVTX-009 is classified as an anti-inflammatory agent.

Investigated diseases

Hidradenitis Suppurativa – Hidradenitis suppurativa is a chronic skin condition characterized by the formation of painful lumps under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can become inflamed and may rupture, leading to the formation of abscesses and tunnels under the skin. Over time, the condition can cause scarring and the development of sinus tracts, which are channels that connect the lumps under the skin. The disease often progresses with periods of flare-ups and remission, where symptoms may temporarily improve. The exact cause of hidradenitis suppurativa is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514562-40-00Protocol codeAVTX-009-HS-201Estimated enrolment297 patientsSponsorAvalo Therapeutics Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).