Status:
COMPLETED
VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita
Lead Sponsor:
Palvella Therapeutics, Inc.
Conditions:
Pachyonychia Congenita
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Key
- Adult patients 18 years or older,
- Previously completed the VALO protocol, or VALO-2 K6C/17 sub-study, and received meaningful benefit from investigational PTX-022 as determined by the clinician.
- Key
Exclusion
- Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications or to PTX-022
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04520750
Start Date
September 1 2020
End Date
December 15 2022
Last Update
August 29 2024
Active Locations (4)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85053
2
Stanford University
Palo Alto, California, United States, 94304
3
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
4
University of Utah
Murray, Utah, United States, 84107