drugset / Trial / NCT07384975

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

NCT07384975 ↗

Phase 2 Recruiting 150 enrolled Navigator Medicines, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-01-05
Primary completion
2027-09
Completion
2027-10

Drugs

EvaluationDrugModalityDoseRoute
Subject NAV-240 Unknown — Intravenous