A Multicenter Open-Label Treatment Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
PALV-08 is a multicenter, open-label treatment (OLT) study enrolling adults with Pachyonychia Congenita (PC) with genotyped keratin mutations KRT6A, KRT6B, KRT6C or KRT16 who were previously enrolled in the PALV-05 (VAPAUS) trial. The purpose of this OLT study is to investigate the safety of long term exposure and pharmacokinetics (PK) of QTORIN rapamycin 3.9% anhydrous gel or PTX-022.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:
• Completed the PALV-05 (VAPAUS) study
• Agree to contraceptive use
Locations
United States
Minnesota
Minnesota Clinical Study Center
RECRUITING
New Brighton
Contact Information
Primary
Emily Cook
emily.cook@palvellatx.com
267-738-6366
Time Frame
Start Date: 2022-11-15
Estimated Completion Date: 2023-11
Participants
Target number of participants: 45
Treatments
Experimental: PTX-022
Related Therapeutic Areas
Sponsors
Leads: Palvella Therapeutics, Inc.