Clinical Trial

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

Recruiting Phase 3
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Record status
This record was last updated December 9, 2022 (before its estimated October 2023 completion). Its status may not reflect the trial's current state.
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".
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-12-01.
Status change: Recruiting → Terminated 2025-01-02
Trial Details
NCT Number NCT05643872
Lead Sponsor Palvella Therapeutics, Inc.
Conditions Pachyonychia Congenita
Enrollment 45 participants
Start Date 2022-11-15
Primary Completion 2023-10 (estimated)
Study Completion 2023-11 (estimated)
Updated on ClinicalTrials.gov 2022-12-09