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Trial to Determine the Immunomodulatory Activity of PTM-001 in Patients With Hidradenitis Suppurativa | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

NCT05020730•Phoenicis Therapeutics

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (3)

Phoenicis Investigative Site

Redwood City, California, United States

Phoenicis Investigative Site

Worcester, Massachusetts, United States

Phoenicis Investigative Site

Cincinnati, Ohio, United States

Key Dates

Start Date

May 5, 2022

Primary Completion Date

December 1, 2023

Completion Date

June 1, 2024

Last Updated

October 26, 2022

Enrollment

ESTIMATED participants

Conditions

Hidradenitis Suppurativa

Interventions

PTM-001

DRUG

Placebo

DRUG

Contacts

Ramsey Johnson, MSM

CONTACT

978-726-1478 ramsey@phoenicistx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study With CIT-013 in HS Patients

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