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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Navigator Medicines, Inc.
Study ID
NCT07384975
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • NAV-240 — DRUG
    NAV-240 for Intravenous Infusion
  • Placebo to match NAV-240 — DRUG
    Placebo to match NAV-240 for Intravenous Infusion

Study Details

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.

Key Dates

Start date
Jan 5, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NAV-240 Dose 1
    NAV-240 Dose 1
  • Experimental: NAV-240 Dose 2
    NAV-240 Dose 2
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 [ Time Frame: Baseline to Week 16 ]

Central Contacts

  • Associate Director, Clinical Operations
    +1 415 251 7753
    [email protected]
  • Vice President, Development Operations

Locations (10)

FacilityCityStateZIPSite coordinators
Medical Dermatology SpecialistPhoenixArizona85006-
Accel Research Sites NetworkMaitlandFlorida32751-
Cordova Research InstituteMiamiFlorida33182-
Floridian Research InstituteMiamiFlorida33179-
Tory Sullivan MD PA - DermatologyNorth Miami BeachFlorida33162-
MplusM - D&H Tamarac Research CenterTamaracFlorida33321-
ForCare Clinical ResearchTampaFlorida33613-
Kentucky Advanced Medical Research LLCMurrayKentucky42071-
ActivMed Practices & Research, LLCPortsmouthNew Hampshire03801-
Equity Medical, LLCThe BronxNew York10455-

Find similar trials in Phoenix, AZ

By research site
Medical Dermatology Specialist· Phoenix, AZAccel Research Sites Network· Maitland, FLCordova Research Institute· Miami, FLFloridian Research Institute· Miami, FLTory Sullivan MD PA - Dermatology· North Miami Beach, FLMplusM - D&H Tamarac Research Center· Tamarac, FL

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