NCT05020730

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Phoenicis Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	PTM-001	PTM-001 (400 mg) every day for 12 weeks
DRUG	Placebo	Matching placebo every day for 12 weeks

Timeline

• Start date: 2022-05-05
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2021-08-25
• Last updated: 2022-10-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study