drugset / Trial / NCT05643872

A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita

NCT05643872

Phase 3 Recruiting 45 enrolled Palvella Therapeutics, Inc.
NaSingle-groupOpen-labelTreatment

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".

Timeline

Start
2022-11-15
Primary completion
2023-10
Completion
2023-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule 3.9 %