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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 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.

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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

Pachyonychia Congenita

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

FieldValue
Enrollment Target 36 participants
Start Date 2020-09-01
Est. Completion 2022-12-15
Phase Phase 3

Sponsor

Palvella Therapeutics

9 total trials

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What the Registry Record Tells You About NCT04520750

The ClinicalTrials.gov registry entry for NCT04520750 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 533-participant average among 4 other Pachyonychia Congenita trials with a reported enrollment target (93% lower). The listed sponsor is Palvella Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 4 distinct geographic areas - top geographies include 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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