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

January 26, 2026 updated by: Navigator Medicines, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Vice President, Development Operations

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Medical Dermatology Specialist
    • Florida
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Accel Research Sites Network
      • Miami, Florida, United States, 33179
        • Recruiting
        • Floridian Research Institute
      • Miami, Florida, United States, 33182
        • Recruiting
        • Cordova Research Institute
      • North Miami Beach, Florida, United States, 33162
        • Recruiting
        • Tory Sullivan MD PA - Dermatology
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • MplusM - D&H Tamarac Research Center
      • Tampa, Florida, United States, 33613
        • Recruiting
        • ForCare Clinical Research
    • Kentucky
      • Murray, Kentucky, United States, 42071
        • Recruiting
        • Kentucky Advanced Medical Research LLC
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Recruiting
        • ActivMed Practices & Research, LLC
    • New York
      • The Bronx, New York, United States, 10455
        • Recruiting
        • Equity Medical, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • History of HS for ≥ 6 months
  • Abscesses and Inflammatory Nodules (lesion) count ≥ 5
  • Inflammatory HS lesions in at least 2 different body regions, one of which must be Hurley Stage II or III
  • Inadequate response to at least one course of antibiotics
  • Topical antiseptics are not required but allowed. If in use, the participant must agree to use one single product consistently through Week 16.
  • Use of oral antibiotics is allowed during the study under the following conditions: the dose and regimen must remain stable until Week 16. Allowed oral antibiotics include doxycycline, minocycline, or tetracycline.
  • Female participants of childbearing potential must have a negative pregnancy test
  • Participants of reproductive potential must use a highly effective method of contraception

Exclusion Criteria:

  • > 20 draining tunnel count
  • Active skin disease (bacterial, fungal, viral infection) that, in the opinion of the Investigator, could interfere with assessment of HS or requires treatment with antibiotic(s) also used to treat HS.
  • Has had major surgery, including HS surgery, within 12 weeks prior to Day 1
  • History of alcohol or drug abuse within the past 2 years.
  • A positive urine drug screen at Screening
  • History or evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HCV), or a positive test at Screening
  • History or current diagnosis of active tuberculosis (TB), untreated latent TB infection (LTBI), or undergoing current treatment for LTBI, determined by positive TB test
  • History of moderate to severe heart failure or recent (within past 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting.
  • History of immune deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo to match NAV-240
Placebo to match NAV-240 for Intravenous Infusion
Experimental: NAV-240 Dose 1
Drug: NAV-240
NAV-240 for Intravenous Infusion
Experimental: NAV-240 Dose 2
Drug: NAV-240
NAV-240 for Intravenous Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75
Time Frame: Baseline to Week 16
HiSCR75 is defined as at least a 75% reduction in total abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining tunnel count relative to baseline.
Baseline to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving skin pain numeric rating scale (NRS) 30 response
Time Frame: Baseline to Week 16
NRS30 is defined as a ≥ 30% reduction and at least a 2-unit reduction from baseline in skin pain on the NRS, for participants with a baseline skin pain NRS ≥ 3, based on the weekly average of the worst skin pain in a 24-hour recall period (maximal daily pain).
Baseline to Week 16
Proportion of participants achieving HiSCR50
Time Frame: Baseline to Week 16
HiSCR50 is defined as at least a 50% reduction in total AN count with no increase in abscess count and no increase in draining tunnel count relative to baseline.
Baseline to Week 16
Proportion of participants achieving a Dermatology Life Quality Index (DLQI) improvement (reduction) of ≥ 4 points among participants with DLQI ≥ 4 at baseline
Time Frame: Baseline to Week 16
Baseline to Week 16
Proportion of participants with HS flare
Time Frame: Baseline to Week 16
Baseline to Week 16
Change in the International Hidradenitis Suppurativa Severity Score System (IHS4) scores
Time Frame: Baseline to Week 16
Baseline to Week 16
Change from baseline in AN count
Time Frame: Baseline to Week 16
Baseline to Week 16
Change from baseline in the number of draining tunnels
Time Frame: Baseline to Week 16
Baseline to Week 16

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of TEAEs, SAEs and adverse events of special interest (AESIs)
Time Frame: Baseline to Week 16
Baseline to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navigator Medicines, Inc.

Investigators

  • Study Director: Lara Pupim, MD, MSCI, Navigator Medicines, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAV-240-201
  • 2025-523557-33-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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