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

Phoenicis Therapeutics

Status and phase

Enrolling

Phase 2

Conditions

Hidradenitis Suppurativa

Treatments

Drug: PTM-001

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05020730

PTM-001-01

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.