Study PTM-001-01 is a 12-week, randomized, placebo controlled, double blind study with a 12 week open-label extension to examine the immunomodulatory activity of PTM-001 in participants with Hidradenitis Suppurativa (HS). Participants will be randomized to receive PTM-001 (400 mg) or matching placebo every day for 12 weeks after which all participants will receive open-label PTM-001 400 mg daily for an additional 12 weeks. Randomization will be stratified by Hurley Stage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Phoenicis Investigative Site
Redwood City, California, United States
RECRUITINGPhoenicis Investigative Site
Worcester, Massachusetts, United States
RECRUITINGPhoenicis Investigative Site
Cincinnati, Ohio, United States
RECRUITINGEffect of PTM-001 on IL-1β protein levels in lesional skin biopsies
Time frame: Baseline to Week 12
Demonstrate a change in IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 protein levels in lesional skin biopsies
Time frame: Baseline to Week 12
Demonstrate a change in IL-1β, IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 mRNA expression in lesional skin biopsies
Time frame: Baseline to Week 12
Demonstrate a change in IL-1β, IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 protein levels in serum
Time frame: Baseline to Week 12
Demonstrate a change in serum amyloid A levels
Time frame: Baseline to Week 12
Change in Pain, as measured using a 10-point numerical rating scale, 1 through 10, with 10 being the worst.
Time frame: Baseline to Week 12
Change in Quality of Life using Dermatology Life Quality Index (DLQI)
Time frame: Baseline to Week 12
Change in clinical status using the Hurley Staging
Time frame: Baseline to Week 12
Change in clinical status using the International Hidradenitis Suppurative Severity Score System (IHS4)
Time frame: Baseline to Week 12
Change in clinical status using the Hidradenitis Suppurative Clinical Response (HiSCR)
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Time frame: Baseline to Week 12
Change in clinical status using the Hidradenitis Suppurative Physician Global Assessment (HS-PGA)
Time frame: Baseline to Week 12
Change in clinical status using the Hidradenitis Suppurative Area and Severity Index-Revised (HASI-R)
Time frame: Baseline to Week 12
Change in abscesses and inflammatory nodules count (AN count)
Time frame: Baseline to Week 12