drugset / Trial / NCT04520750

VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita

NCT04520750 ↗

Phase 3 Completed 36 enrolled Palvella Therapeutics, Inc.
NaSingle-groupOpen-labelTreatment

Summary

VALO-2 is a multicenter, open-label extension (OLE) study enrolling patients with genotyped keratin mutations KRT6A, KRT6B and KRT16 who were previously treated with investigational PTX-022 during the VALO study. The purpose of the OLE study is to investigate long term exposure to investigational PTX-022 and evaluate safety and efficacy data. A sub-study is included to evaluate safety and efficacy of patients with genotyped keratin mutations of KRT6C and KRT17 not previously treated with investigational PTX-022.

Timeline

Start
2020-09-01
Primary completion
2021-06-30
Completion
2022-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject PTX-022 Unknown — —