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

NCT07384975 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-03

No results posted yet for this study

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

DRUG

NAV-240

NAV-240 for Intravenous Infusion

DRUG

Placebo to match NAV-240

Placebo to match NAV-240 for Intravenous Infusion

Sponsors & Collaborators

  • Navigator Medicines, Inc.

    lead INDUSTRY

Principal Investigators

  • Lara Pupim, MD, MSCI · Navigator Medicines, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2027-09-30
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07384975 on ClinicalTrials.gov