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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Gyncentrum Sp. z o.o. Katowice Poland

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
St. Josef-Hospital Bochum Germany
Muehlenkreiskliniken AöR Minden Germany
Klinika Ambroziak Sp. z o.o. Warsaw Poland
Labderm Essence Sp. z o.o. Ozarowice Poland
University Of Debrecen Debrecen Hungary
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Charite Universitaetsmedizin Berlin KöR Berlin Germany
University Of Pecs Pecs Hungary
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
ASMC – IPSMC – Skin And Venereal Diseases Sofia Bulgaria
Futuremeds S.R.L. Brasov Romania
Futuremeds S.R.L. Galati Romania
Medical Center Medconsult Pleven OOD Lovech Bulgaria
OT Co Zdrowie Sp. z o.o. Warsaw Poland
Grwrjh Ufvmmutyic Fnlylskuf Frankfurt Germany
Dijoumxaxv Sje z oler Wroclaw Poland
Dyraqykyjvet Qajjx Mainz Germany
Mflgzdi Cvqnfs Meakozeotw Pctpsi Oxc Pleven Bulgaria
Dcutrvvc Jkmha Zruuznl Kielce Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
01.04.2026
Germany Germany
Recruiting
01.04.2026
Hungary Hungary
Not yet recruiting
01.04.2026
Poland Poland
Recruiting
01.04.2026
Romania Romania
Recruiting
01.04.2026

Trial locations

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.

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 ID:
2025-523557-33-00
Protocol code:
NAV-240-201
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

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  • A study to evaluate the effectiveness and safety of LAD328 in adults with moderate to severe hidradenitis suppurativa

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    Investigated diseases:
    Investigated drugs:
    Bulgaria France Germany Poland Spain