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Clinical trials are studying NAV-240 in adults with moderate-to-severe hidradenitis suppurativa. These studies aim to see whether NAV-240 can improve symptoms better than placebo and measure results such as clinical response after treatment.

Table of Contents

Trial overview

This study is an interventional trial, which means researchers give a study treatment and then watch what happens over time.[1] It is testing NAV-240 in adults with moderate-to-severe hidradenitis suppurativa, a long-term skin condition that causes painful lumps and can lead to abscesses and draining tunnels.[1]

The trial is in Phase 2, a stage that usually looks at whether a treatment seems to work and continues to collect safety information.[1] The study title says it is designed to assess NAV-240 in adult participants with hidradenitis suppurativa.[1]

Who can join the study

The available trial data says the study is for adult participants with moderate-to-severe hidradenitis suppurativa.[1] No other eligibility details are provided in the source data, so the full entry criteria are not listed here.[1]

What is being measured

The main endpoint is HiSCR 75 at Week 16, which stands for Hidradenitis Suppurativa Clinical Response 75.[1] In simple terms, this means the study checks whether a participant has at least a 75% drop in inflamed skin bumps, called abscesses and inflammatory nodules, compared with the start of the study.[1]

To count as a response, there must also be no increase in the number of abscesses or draining tunnels, which are channels under the skin that can leak fluid or pus.[1] The study uses the start of treatment, called baseline, as the comparison point.[1]

Study design and comparison treatment

The brief summary says the main goal is to find out whether NAV-240 works more effectively than a placebo, also called a dummy treatment.[1] A placebo looks like a treatment but does not contain the study drug, so researchers can compare results fairly.[1]

The intervention list includes NAV-240 and a sodium chloride solution used as the control treatment in the study record.[1] Both are listed as being given by intravenous use, which means through a vein.[1]

Trial status and size

The trial status is Authorised, meaning it has been approved to move forward in the source record.[1] The planned enrollment is 204 participants, so the study is designed to include that number of people.[1]

At Week 16, researchers will measure the main outcome and compare the results between the study treatment and the control group.[1] This helps show whether NAV-240 gives meaningful improvement in hidradenitis suppurativa symptoms.[1]

Trial ID Phase Condition studied Status Enrollment
2025-523557-33-00 Phase 2 Moderate-to-Severe Hidradenitis Suppurativa Authorised 204

FAQ

  • What is NAV-240 being studied for? NAV-240 is being studied in adults with moderate-to-severe hidradenitis suppurativa. The trial is looking at whether it can improve the skin condition better than placebo.
  • Who can take part in the NAV-240 trial? The trial is for adult participants with moderate-to-severe hidradenitis suppurativa. The study data does not list other eligibility details.
  • What phase is the NAV-240 trial? The study is in Phase 2. This means it is an early study that looks at how well the treatment works and continues to assess safety.
  • What is the main outcome being measured? The main outcome is HiSCR 75 at Week 16. This means the study checks whether people have at least a 75% drop in inflamed bumps, with no increase in abscesses or draining tunnels.
  • Is NAV-240 being compared with another treatment? Yes. The study aims to see if NAV-240 works more effectively than a dummy treatment called placebo. Placebo looks like a treatment but does not contain the study drug.

Ongoing Clinical Trials on IMB 101

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

    Recruiting

    1 1
    Investigated drugs:
    Bulgaria Germany Hungary Poland Romania

Glossary

  • Hidradenitis Suppurativa (HS): A long-term skin condition that causes painful lumps, abscesses, and draining tunnels, usually in areas where skin rubs together.
  • Moderate-to-Severe: A level of illness that is more than mild and causes a greater number of symptoms or more serious symptoms.
  • Phase 2: A clinical trial stage that mainly checks whether a treatment seems to work and continues to gather safety information.
  • Interventional study: A study where researchers give a treatment and then measure what happens.
  • Placebo: A dummy treatment used for comparison. It does not contain the active study drug.
  • Clinical response: An improvement in the signs of a disease after treatment.
  • HiSCR 75: A study measure meaning at least a 75% reduction in inflamed bumps, with no increase in abscesses or draining tunnels.
  • Abscess: A painful pocket of pus under the skin.
  • Inflammatory nodule: A swollen, firm lump caused by inflammation.
  • Draining tunnel: A channel under the skin that can leak fluid or pus.
  • Baseline: The starting point before treatment begins, used for comparison later in the study.
  • Week 16: The time point 16 weeks after the study starts, when the main result is measured.

References