Trial to Determine the Immunomodulatory Activity of PTM-001 in Patients With Hidradenitis Suppurativa
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Hidradenitis Suppurativa
In brief
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.
Key facts
- Study ID
- NCT05020730
- Run by
- Phoenicis Therapeutics
- People needed
- 50
- Starts
- 2022-05-05
- Expected to finish
- 2024-06-01
- Last updated by the study team
- 2022-10-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Phoenicis Investigative Site — Redwood City, California, United States (enrolling)
- Phoenicis Investigative Site — Worcester, Massachusetts, United States (enrolling)
- Phoenicis Investigative Site — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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