Recruiting
Phase 2

PTM-001

Sponsor:

Phoenicis Therapeutics

Code:

NCT05020730

Conditions

Hidradenitis Suppurativa

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PTM-001

Placebo

Study Details

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.

Conditions

Hidradenitis Suppurativa

Study ID

NCT05020730

Start date

May 5, 2022

Status verified date

Oct, 2022

Completion date

Jun, 2024

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PTM-001 400 mg daily for 12 weeks

placebo comparator: Placebo daily for 12 weeks

Interventions

PTM-001

PTM-001 (400 mg) every day for 12 weeks

Placebo

Matching placebo every day for 12 weeks

Primary outcome measure

  • Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies [ Time Frame: Baseline to Week 12 ]

Central Contacts and Locations

Central contacts

Ramsey Johnson, MSM

978-726-1478ramsey@phoenicistx.com

Locations

Phoenicis Investigative Site

Recruiting

Redwood City, California, United States, 94063

Phoenicis Investigative Site

Recruiting

Worcester, Massachusetts, United States, 01655

Phoenicis Investigative Site

Recruiting

Cincinnati, Ohio, United States, 45229

More Information

Sponsor

Phoenicis Therapeutics

Last update posted

Oct 26, 2022

Last verified

Oct, 2022

Keywords

  • Hidradenitis Suppurativa
  • HS
  • Inflammatory skin disease
  • Humira
  • P2X7
  • IL-1β

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Phoenicis Therapeutics on 2022-10-26.