Phase 2a Study of NAV-240 Intravenous Treatment in Adults with Moderate-to-Severe Hidradenitis Suppurativa

What this Trial Is About

Researchers are studying the effectiveness of NAV-240 compared to a placebo in adults with moderate-to-severe Hidradenitis Suppurativa HS. The main goal is to see how many participants achieve at least a 75% reduction in inflamed skin bumps by Week 16 without an increase in abscesses or draining tunnels. This phase 2a study involves participants who have stable HS and have not responded well to antibiotics. Participants will be randomly assigned to receive one of two doses of NAV-240 or a placebo through intravenous infusions. They will receive the assigned treatment during the study period and attend up to 9 clinic visits over 22 weeks for checkups and tests. Participants will also complete a daily diary to record their skin pain. The study includes monitoring skin lesions and other skin-related outcomes over 16 weeks. During the study, participants will have regular assessments, including lesion counts and skin pain evaluations. Researchers will measure outcomes such as the clinical response of HS, skin pain improvement, quality of life changes, and flare occurrences. Safety and treatment effects will be monitored through clinic visits and participant diaries. The total study duration is about 22 weeks, with the main results assessed at Week 16.

A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa