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A study to evaluate the effectiveness of NAV-240 in adults with moderate-to-severe hidradenitis suppurativa

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What is this trial about?

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

This study investigates a treatment for individuals with Hidradenitis Suppurativa, a chronic skin condition that causes painful bumps, abscesses (painful, pus-filled lumps), and draining tunnels (channels under the skin that leak fluid) under the skin. The research aims to determine if the experimental drug NAV-240 is more effective than a placebo in managing this condition.

Participants in this clinical trial will be randomly assigned to receive either NAV-240 or a placebo consisting of sodium chloride. The medication will be administered through an intravenous method, which means it is delivered directly into a vein using a solution for infusion. To ensure the results are reliable, the study is double-blind, meaning neither the participants nor the researchers know which treatment is being given during the course of the study.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation and treatment

    Participation involves receiving either the test medication, known as nav-240, or a placebo, which is a dummy treatment containing sodium chloride (salt water) that does not contain the active medicine.

    The medication is administered through an intravenous infusion, which means it is delivered directly into a vein.

  2. Step 2

    Treatment period and monitoring

    The treatment period continues for 16 weeks.

    During this time, the effectiveness of the treatment is monitored by measuring the reduction in inflamed skin bumps, such as abscesses (painful, pus-filled lumps) and inflammatory nodules (painful lumps under the skin).

    The number of draining tunnels, which are channels under the skin that leak fluid or pus, is also tracked.

    pain levels are assessed using a scale to check for a reduction in discomfort.

    The impact on quality of life and the severity of the skin condition is measured throughout the 16 weeks.

Who can join the trial?

6 criteria

  • You must be between 18 and 70 years old at the time you agree to join the study.
  • You must have had Hidradenitis Suppurativa, which is a chronic skin condition that causes painful lumps under the skin, for at least 6 months.
  • You must have at least 5 abscesses, which are painful, pus-filled lumps, and inflamed skin lesions, which are red, swollen, and irritated areas of skin.
  • These skin issues must be located in at least 2 different parts of your body.
  • At least one of these areas must show moderate to severe symptoms, specifically classified as Hurley Stage II or Hurley Stage III, which are medical scales used to describe the severity and extent of the skin disease.
  • You must have had an inadequate response to at least one course of antibiotics, meaning the medicine used to fight bacterial infections did not work well enough to improve your condition, as decided by the study doctor.

Who cannot join the trial?

5 criteria

  • People who have more than 20 draining tunnels, which are small passages or tracts that form under the skin and allow fluid to leak out.
  • People currently experiencing an active skin infection, which means a present illness caused by bacteria (tiny germs), fungi (like yeast or mold), or viruses (tiny germs that cause illnesses like the flu).
  • People with an inflammatory condition, which is a state where the body's immune system is causing redness, swelling, or pain in the skin.
  • People who have had major surgery, which is a large and serious medical operation, including surgery specifically for Hidradenitis Suppurativa.
  • People who are planning to have major surgery while the study is taking place.
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Investigated drugs

NAV-240 is the experimental treatment being tested to see if it can help reduce the symptoms of moderate-to-severe hidradenitis suppurativa.

What is already known about the treatment

  • Sodium chloride

    This substance is administered as a liquid through a vein during an infusion to act as a placebo. It is a widely used, well-known salt solution found in standard medical practice to maintain fluid balance in the body. In this study, it serves as an inactive substance to help compare the effects of the actual test medication.

  • NAV-240

    This medication is given as a concentrated liquid that is mixed into a solution and administered directly into a vein. It is currently an experimental drug being studied in clinical trials to see if it can effectively treat moderate-to-severe hidradenitis suppurativa, a painful skin condition. This substance belongs to a class of investigational therapies designed to target specific molecular pathways involved in skin inflammation to reduce symptoms.

Investigated diseases

Hidradenitis Suppurativa - This is a chronic skin condition that primarily affects areas where skin rubs together, such as the armpits or groin. It involves the formation of painful, inflamed lumps or bumps under the skin. Over time, these bumps can develop into abscesses that may drain fluid or pus. As the condition progresses, tunnels or channels can form beneath the skin surface, connecting different affected areas. This process can lead to increased inflammation and scarring in the impacted regions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523557-33-00Protocol codeNAV-240-201Estimated enrolment204 patientsSponsorNavigator Medicines Inc.

sourced from the EU Clinical Trials Register and site verification

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