Clinical trial NCT05020730: Trial to Determine the Immunomodulatory Activity of PTM-001 in Patients With Hidradenitis Suppurativa
Official title: A 12-Week Double-Blind, Placebo-Controlled Randomized Phase 2 Trial With a 12-Week Open-Label Extension to Determine the Immunomodulatory Activity of PTM-001 in Patients With Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
HS
Inflammatory skin disease
Humira
P2X7
IL-1β
Lead sponsor: Phoenicis Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to receive PTM-001 (400 mg) or matching placebo every day for 12 weeks after which all patients will receive open-label PTM-001 400 mg daily for an additional 12 weeks
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Had onset of symptoms consistent with HS at least 6 months prior to Screening.
* Has had active HS for at least 2 months.
* Has ≥ 5 HS abscesses or inflammatory nodules at Screening.
* Agrees to maintain baseline wound care and antibiotic therapy, including oral antibiotics, for the duration of the trial.
* Agrees to use contraception

Exclusion Criteria:

* Has other skin disease or condition that can interfere with HS assessment.
* Has a positive test for TB, HIV, hepatitis B and/or hepatitis C at Screening.
* Has a history of retinopathy or known clinically significant cardiovascular or hematologic conditions.
* Has taken any biologic drug within 3 serum half-lives. A list of potential biologics and their half-lives
* Has started oral antibiotics within 28 days of Study Day 1.
* Has, within 2 weeks prior to Day 1, received a medication prohibited based on cytochrome P450 (CYP3A4) interaction
* Has such extensive disease that, in the opinion of the Investigator, it is difficult to discriminate between active lesions and scarring.
* Has more than 15 active tunnels at Screening.
* Is pregnant, nursing or considering becoming pregnant.
* Has a history of malignancy except non-melanoma skin cancer or cervical carcinoma in situ.

Primary outcomes:
measure: Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Demonstrate a change in IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 protein levels in lesional skin biopsies
timeFrame: Baseline to Week 12
measure: 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
timeFrame: Baseline to Week 12
measure: Demonstrate a change in IL-1β, IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 protein levels in serum
timeFrame: Baseline to Week 12
measure: Demonstrate a change in serum amyloid A levels
timeFrame: Baseline to Week 12
measure: Change in Pain, as measured using a 10-point numerical rating scale, 1 through 10, with 10 being the worst.
timeFrame: Baseline to Week 12
measure: Change in Quality of Life using Dermatology Life Quality Index (DLQI)
timeFrame: Baseline to Week 12
measure: Change in clinical status using the Hurley Staging
timeFrame: Baseline to Week 12
measure: Change in clinical status using the International Hidradenitis Suppurative Severity Score System (IHS4)
timeFrame: Baseline to Week 12
measure: Change in clinical status using the Hidradenitis Suppurative Clinical Response (HiSCR)
timeFrame: Baseline to Week 12
measure: Change in clinical status using the Hidradenitis Suppurative Physician Global Assessment (HS-PGA)
timeFrame: Baseline to Week 12
measure: Change in clinical status using the Hidradenitis Suppurative Area and Severity Index-Revised (HASI-R)
timeFrame: Baseline to Week 12
measure: Change in abscesses and inflammatory nodules count (AN count)
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Phoenicis Investigative Site
state: California
city: Worcester
country: United States
facility: Phoenicis Investigative Site
state: Massachusetts
city: Cincinnati
country: United States
facility: Phoenicis Investigative Site
state: Ohio
Study officials:
References: