Trial to Determine the Immunomodulatory Activity of PTM-001 in Patients With Hidradenitis Suppurativa

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 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 Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: PTM-001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ramsey Johnson, MSM; Phone Number: 978-726-1478; Email: ramsey@phoenicistx.com

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Phoenicis Investigative Site
      • Contact: (978) 726-1478
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • Phoenicis Investigative Site
      • Contact: (978) 726-1478
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Phoenicis Investigative Site
      • Contact: (978) 726-1478

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PTM-001 400 mg daily for 12 weeks	Drug: PTM-001; PTM-001 (400 mg) every day for 12 weeks
Placebo Comparator: Placebo daily for 12 weeks	Drug: Placebo; Matching placebo every day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Demonstrate a change in IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 protein levels in lesional skin biopsies	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	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	Baseline to Week 12
Demonstrate a change in serum amyloid A levels	Baseline to Week 12
Change in Pain, as measured using a 10-point numerical rating scale, 1 through 10, with 10 being the worst.	Baseline to Week 12
Change in Quality of Life using Dermatology Life Quality Index (DLQI)	Baseline to Week 12
Change in clinical status using the Hurley Staging	Baseline to Week 12
Change in clinical status using the International Hidradenitis Suppurative Severity Score System (IHS4)	Baseline to Week 12
Change in clinical status using the Hidradenitis Suppurative Clinical Response (HiSCR)	Baseline to Week 12
Change in clinical status using the Hidradenitis Suppurative Physician Global Assessment (HS-PGA)	Baseline to Week 12
Change in clinical status using the Hidradenitis Suppurative Area and Severity Index-Revised (HASI-R)	Baseline to Week 12
Change in abscesses and inflammatory nodules count (AN count)	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Phoenicis Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: P2X7; HS; Humira; Hidradenitis Suppurativa; IL-1β; Inflammatory skin disease
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: PTM-001-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No