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

NCT07384975 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: NAV-240-2012025-523557-33-00
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 10

Brief 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)

Keywords

NAV-240; HS; Hidradenitis Suppurativa; Phase 2; Moderate-to-Severe HS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Proportion of participants achieving skin pain numeric rating scale (NRS) 30 response

  Baseline to Week 16

• Proportion of participants achieving HiSCR50

  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

  Baseline to Week 16

• Proportion of participants with HS flare

  Baseline to Week 16

• Change in the International Hidradenitis Suppurativa Severity Score System (IHS4) scores

  Baseline to Week 16

Other Outcomes (1)

• Incidence of TEAEs, SAEs and adverse events of special interest (AESIs)

  Baseline to Week 16

Study Arms (3)

NAV-240 Dose 1

EXPERIMENTAL

NAV-240 Dose 1

Drug: NAV-240

NAV-240 Dose 2

EXPERIMENTAL

NAV-240 Dose 2

Drug: NAV-240

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo to match NAV-240

Interventions

NAV-240 DRUG

NAV-240 for Intravenous Infusion

NAV-240 Dose 1; NAV-240 Dose 2

Placebo to match NAV-240 DRUG

Placebo to match NAV-240 for Intravenous Infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \> 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

Sponsors & Collaborators

• Navigator Medicines, Inc.: lead

Study Sites (10)

Medical Dermatology Specialist

Phoenix, Arizona, 85006, United States

RECRUITING

Accel Research Sites Network

Maitland, Florida, 32751, United States

RECRUITING

Floridian Research Institute

Miami, Florida, 33179, United States

RECRUITING

Cordova Research Institute

Miami, Florida, 33182, United States

RECRUITING

Tory Sullivan MD PA - Dermatology

North Miami Beach, Florida, 33162, United States

RECRUITING

MplusM - D&H Tamarac Research Center

Tamarac, Florida, 33321, United States

RECRUITING

ForCare Clinical Research

Tampa, Florida, 33613, United States

RECRUITING

Kentucky Advanced Medical Research LLC

Murray, Kentucky, 42071, United States

RECRUITING

ActivMed Practices & Research, LLC

Portsmouth, New Hampshire, 03801, United States

RECRUITING

Equity Medical, LLC

The Bronx, New York, 10455, United States

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Lara Pupim, MD, MSCI

  Navigator Medicines, Inc.

  STUDY DIRECTOR

Central Study Contacts

Associate Director, Clinical Operations

CONTACT

+1 415 251 7753; info@navigatormeds.com

Vice President, Development Operations

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)