NCT05643872

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Palvella Therapeutics, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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".

Conditions

• Pachyonychia Congenita

Interventions

Type	Name	Description
DRUG	PTX-022	QTORIN rapamycin 3.9% anhydrous gel

Timeline

• Start date: 2022-11-15
• Primary completion: 2023-10-01
• Completion: 2023-11-01
• First posted: 2022-12-09
• Last updated: 2022-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study