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

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: Hidradenitis Suppurativa (HS)
• Intervention / Treatment: Drug: NAV-240; Drug: Placebo to match NAV-240

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Associate Director, Clinical Operations; Phone Number: +1 415 251 7753; Email: info@navigatormeds.com
• Study Contact Backup: Name: Vice President, Development Operations

Study Locations

• Bulgaria
  • Lovech, Bulgaria
    • Recruiting
    • Medical Center Medconsult Pleven
  • Pleven, Bulgaria
    • Recruiting
    • MC Medconsult Pleven
  • Sofia, Bulgaria
    • Recruiting
    • Ambulatory for Specialized Medical Help - skin and venereal diseases
  • Sofia, Bulgaria
    • Recruiting
    • Diagnostic Consultative Center Fokus-5 Medical Establishment for Outpatient Care EOOD
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4W 2N2
      • Recruiting
      • Research Toronto
    • Toronto, Ontario, Canada, M4E 1R7
      • Recruiting
      • FACET Dermatology
  • Quebec
    • Montreal, Quebec, Canada, QC H1Y 3L1
      • Recruiting
      • Centre de Recherche Saint-Louis (Quebec)
• Georgia
  • Tbilisi, Georgia
    • Recruiting
    • LTD Aversi Clinic - Dermatology
  • Tbilisi, Georgia
    • Recruiting
    • LTD Israel-Georgian Medical Research Clinic Healthycore
  • Tbilisi, Georgia
    • Recruiting
    • LTD MediClub Georgia
  • Tbilisi, Georgia
    • Not yet recruiting
    • LTD Multiprofile Clinic Consilium Medulla
• Germany
  • Bochum, Germany
    • Recruiting
    • St. Josef Hospital Bochum - Dermatologie, Venerologie und Allergologie
  • Frankfurt, Germany
    • Recruiting
    • J. W. Goethe Universitaet Frankfurt Zentrum f. Dermatologie
  • Kiel, Germany
    • Recruiting
    • Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Kiel - Klinik fuer Dermatologie, Venerologie und Allergologie
  • Lübeck, Germany
    • Recruiting
    • Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Luebeck
  • Mainz, Germany
    • Recruiting
    • BAG Dres. med. Quist PartG
• Hungary
  • Debrecen, Hungary
    • Recruiting
    • Debreceni Egyetem Klinikai Központ - Dermatology
  • Pécs, Hungary
    • Recruiting
    • Pécsi Tudományegyetem Klinikai Központ - Bőr-, Nemikórtani és Onkoderma
• Poland
  • Katowice, Poland
    • Recruiting
    • Holsamed
  • Kielce, Poland
    • Recruiting
    • Dermedic Jacek Zdybski
  • Ossy, Poland
    • Recruiting
    • Labderm Essence
  • Warsaw, Poland
    • Recruiting
    • Klinika Ambroziak Dermatologia
  • Warsaw, Poland
    • Recruiting
    • OT CO Zdrowie
  • Wroclaw, Poland
    • Recruiting
    • Centrum Columbus
• Romania
  • Brasov, Romania
    • Recruiting
    • Futuremeds Romania - Brasov - Dermatology
  • Bucharest, Romania
    • Recruiting
    • Spitalul Clinic Colentina - Dermatology II
  • Galati, Romania
    • Recruiting
    • Futuremeds Romania - Galati - Dermatology
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • Medical Dermatology Specialist
    • Scottsdale, Arizona, United States, 85260
      • Recruiting
      • Scottsdale Clinical Trials
  • 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
      • Ziaderm Research, LLC
    • Tamarac, Florida, United States, 33321
      • Recruiting
      • FWD Clinical Research
    • 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
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
  • Mississippi
    • Ridgeland, Mississippi, United States, 39157
      • Recruiting
      • SKY Integrative Medical Center
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Recruiting
      • StracSkin, PLLC
  • New York
    • The Bronx, New York, United States, 10455
      • Recruiting
      • Equity Medical, Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of stable HS for ≥ 2 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/washes 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 or latent pulmonary or extrapulmonary TB infection or a positive test at Screening
• History of moderate to severe heart failure or recent (within past 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting.
• Any history of malignancy (including lymphoma and leukemia) other than a successfully treated and considered cured non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized carcinoma in situ
• History of immune deficiency

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

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	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 HiSCR50	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 with HS flare		Baseline to Week 16
Change from baseline in AN count		Baseline to Week 16
Change from baseline in the number of draining tunnels		Baseline to Week 16
Proportion of participants achieving skin pain numeric rating scale (NRS) 30 response	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). The skin pain NRS is a single-item measure designed to capture information on self-reported skin pain severity by rating "the worst level of skin pain in the past 24 hours" as a number on a numerical rating scale from 0 (no pain) to 10 (worst pain imaginable).	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	The DLQI is a simple validated 10-item, dermatology-specific, quality-of-life (QoL) questionnaire. Each item in the questionnaire can receive an impairment degree on a 4-point-scale (0 - not at all, 3 - very much), and the higher the score, the greater the impairment of QoL.	Baseline to Week 16
Change in the International Hidradenitis Suppurativa Severity Score System (IHS4) scores	The IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less is a mild disease, 4-10 signifies moderate disease and 11 or higher signifies severe disease.	Baseline to Week 16

Other Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Phase 2; HS; Hidradenitis Suppurativa; NAV-240; Moderate-to-Severe HS
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa
• 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