In short
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.
Key points
- NAV-240 is being studied in a Phase 2 clinical trial for adults with moderate-to-severe hidradenitis suppurativa. The study is interventional, which means participants receive a study treatment and outcomes are measured over time. Researchers want to know whether NAV-240 works better than placebo. The main result is HiSCR 75 at Week 16, a measure of major improvement in inflamed skin bumps without worsening abscesses or draining tunnels. The trial plans to enroll 204 participants and is currently authorised.
Trial overview
This study is an interventional trial, which means researchers give a study treatment and then watch what happens over time. 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.
The trial is in Phase 2, a stage that usually looks at whether a treatment seems to work and continues to collect safety information. The study title says it is designed to assess NAV-240 in adult participants with hidradenitis suppurativa.
Who can join the study
The available trial data says the study is for adult participants with moderate-to-severe hidradenitis suppurativa. No other eligibility details are provided in the source data, so the full entry criteria are not listed here.
What is being measured
The main endpoint is HiSCR 75 at Week 16, which stands for Hidradenitis Suppurativa Clinical Response 75. 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.
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. The study uses the start of treatment, called baseline, as the comparison point.
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. A placebo looks like a treatment but does not contain the study drug, so researchers can compare results fairly.
The intervention list includes NAV-240 and a sodium chloride solution used as the control treatment in the study record. Both are listed as being given by intravenous use, which means through a vein.
Trial status and size
The trial status is Authorised, meaning it has been approved to move forward in the source record. The planned enrollment is 204 participants, so the study is designed to include that number of people.
At Week 16, researchers will measure the main outcome and compare the results between the study treatment and the control group. This helps show whether NAV-240 gives meaningful improvement in hidradenitis suppurativa symptoms.