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

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phoenicis Therapeutics

Criteria

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.