A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita

Part of paid clinical trials in New Brighton, Minnesota.

Sponsor
Palvella Therapeutics, Inc.
Study ID
NCT05643872
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Pachyonychia Congenita

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PTX-022 — DRUG
    QTORIN rapamycin 3.9% anhydrous gel

Study Details

PALV-08 is a multicenter, open-label treatment (OLT) study enrolling adults with Pachyonychia Congenita (PC) with genotyped keratin mutations KRT6A, KRT6B, KRT6C or KRT16 who were previously enrolled in the PALV-05 (VAPAUS) trial. The purpose of this OLT study is to investigate the safety of long term exposure and pharmacokinetics (PK) of QTORIN rapamycin 3.9% anhydrous gel or "PTX-022".

Key Dates

Start date
Nov 15, 2022
Status verified
Dec 2022
Primary completion
Oct 31, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PTX-022

Primary Outcome Measure

Treatment emergent adverse events [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Minnesota Clinical Study CenterNew BrightonMinnesota55112
Study Coordinator
763-502-2929
Steven E Kempers, MD, FAAD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Brighton, MN

By research site
Minnesota Clinical Study Center· New Brighton, MN

Related Studies