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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NAV-240 Dose 1 		NAV-240 Dose 1
  • Drug: NAV-240
    NAV-240 for Intravenous Infusion
Experimental
NAV-240 Dose 2 		NAV-240 Dose 2
  • Drug: NAV-240
    NAV-240 for Intravenous Infusion
Placebo Comparator
Placebo 		Placebo
  • Drug: Placebo to match NAV-240
    Placebo to match NAV-240 for Intravenous Infusion

Recruiting Locations

Medical Dermatology Specialist
Phoenix, Arizona 85006

Scottsdale Clinical Trials
Scottsdale, Arizona 85260

Accel Research Sites Network
Maitland, Florida 32751

Floridian Research Institute
Miami, Florida 33179

Cordova Research Institute
Miami, Florida 33182

Ziaderm Research, LLC
North Miami Beach, Florida 33162

FWD Clinical Research
Tamarac, Florida 33321

MplusM - D&H Tamarac Research Center
Tamarac, Florida 33321

ForCare Clinical Research
Tampa, Florida 33613

Kentucky Advanced Medical Research LLC
Murray, Kentucky 42071

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215

SKY Integrative Medical Center
Ridgeland, Mississippi 39157

StracSkin, PLLC
Portsmouth, New Hampshire 03801

Equity Medical, LLC
The Bronx, New York 10455

More Details

Status
Recruiting
Sponsor
Navigator Medicines, Inc.

Study Contact

Associate Director, Clinical Operations
+1 415 251 7753
info@navigatormeds.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.