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

Completed · Phase 3

Conditions studied: Pachyonychia Congenita

In brief

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.

Key facts

Study ID

NCT04520750

Run by

Palvella Therapeutics, Inc.

People needed

36

Starts

2020-09-01

Expected to finish

2022-12-15

Last updated by the study team

2024-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• Stanford University — Palo Alto, California, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• University of Utah — Murray, Utah, United States

Full record on ClinicalTrials.gov

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