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.

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.