NCT04520750

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

VALO-2: A Multicenter, Phase 3b, Open-Label Treatment Extension Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Palvella Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pachyonychia Congenita

Interventions

Type	Name	Description
DRUG	PTX-022	Safety and Efficacy of PTX-022 in the Treatment of Adults with Pachyonychia Congenita

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-06-30
• Completion: 2022-12-15
• First posted: 2020-08-20
• Last updated: 2024-08-29

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study