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NCT04520750 · ClinicalTrials.gov registry record · Phase 3
VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita
A Phase 3 study of Pachyonychia Congenita, sponsored by Palvella Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 36
- Enrollment target
- 4
- Study locations
NCT04520750: Completed Phase 3 study of Pachyonychia Congenita, sponsored by Palvella Therapeutics.
NCT04520750 is a Phase 3 study of Pachyonychia Congenita that has completed, run by Palvella Therapeutics. The registered enrollment target is 36 participants, below the 533-participant average among 4 other Pachyonychia Congenita trials with a reported enrollment target (93% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04520750, a Phase 3 study of Pachyonychia Congenita, has completed, sponsored by Palvella Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 36 participants
- Enrollment target
- 4
- Study locations
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.
Conditions Studied
Interventions
- DRUG PTX-022
Study Locations (4)
Arizona
- Arizona Research Center - Phoenix
California
- Stanford University - Palo Alto
Minnesota
- Minnesota Clinical Study Center - Fridley
Utah
- University of Utah - Murray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2022-12-15 |
| Phase | Phase 3 |
What the finished NCT04520750 record still lists
NCT04520750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 533-participant average among 4 other Pachyonychia Congenita trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Pachyonychia Congenita appearing as the primary indexed condition, and to 1 intervention - of which PTX-022 is the first listed.
NCT04520750 reports a single indexed study location in Arizona, California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04520750 about?
NCT04520750 is a clinical study titled "VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita". 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 PT...
What is the current status of trial NCT04520750?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 36 participants. The study started on 2020-09-01. Estimated completion is 2022-12-15.
What conditions does trial NCT04520750 study?
This clinical trial studies the following conditions: Pachyonychia Congenita.
What interventions are being tested in trial NCT04520750?
The interventions under investigation include: PTX-022 (DRUG).
Who is sponsoring clinical trial NCT04520750?
This trial is sponsored by Palvella Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04520750 being conducted?
This trial has 4 study locations across Arizona, California, Minnesota, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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