NCT07384975

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

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Navigator Medicines, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hidradenitis Suppurativa (HS)

Interventions

Type	Name	Description
DRUG	NAV-240	NAV-240 for Intravenous Infusion
DRUG	Placebo to match NAV-240	Placebo to match NAV-240 for Intravenous Infusion

Timeline

• Start date: 2026-01-05
• Primary completion: 2027-09-01
• Completion: 2027-10-01
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study