Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
360
Trial Sponsor
Clinical Trial Start Date
September 1, 2020
0Primary Completion Date
June 30, 2021
0Study Completion Date
2022
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
PTX-0220
Interventional Trial Phase
Phase 30
Participating Facility
Official Name
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 Congenita0
Last Updated
December 3, 2021
0Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study 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
No Timeline data yet.
Further Resources
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