Clinical Trial

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

Study acronym: Mainsail
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The main objective of this study is to determine if NAV-240 works more effectively than a dummy treatment (placebo) for participants with moderate-to-severe HS. The main endpoint of this study is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 16, meaning at least a 75% reduction in inflamed skin bumps (abscess and inflammatory nodule (AN) count) with no increase in number of abscesses or draining tunnels (channels under the skin that leak fluid or pus) compared to the baseline (start of the study). Participants will: * Receive NAV-240 dose 1, NAV-240 dose 2 or placebo as a drip into the veins (intravenous infusion). * Visit the clinic up to 9 times for checkups and tests over 22 weeks. * Complete a daily diary about their skin pain.
Protocol Amendment History 1 change
notable Trial sites expanded: 10 -> 41 locations 2026-07-23
Trial Details
NCT Number NCT07384975
Lead Sponsor Navigator Medicines, Inc.
Conditions Hidradenitis Suppurativa (HS)
Enrollment 150 participants
Start Date 2026-01-05
Primary Completion 2027-09 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-22