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

Last updated: December 1, 2022
Sponsor: Palvella Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05643872
PALV-08
  • Ages > 16
  • All Genders

Study Summary

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".

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Completed the PALV-05 (VAPAUS) study
  • Agree to contraceptive use

Exclusion

Key Exclusion Criteria:

  • Females who are pregnant or breastfeeding
  • Concomitant use of sirolimus or any sirolimus-containing medications (systemic ortopical)
  • Any significant concurrent condition that could adversely affect participation and/orthe assessment of the safety and efficacy in the study
  • Prior or planned treatment, including surgery or other medically necessaryintervention deemed by the investigator that could adversely affect participationand/or the assessment of the safety and efficacy in the study

Study Design

Total Participants: 45
Study Start date:
November 15, 2022
Estimated Completion Date:
November 30, 2023

Connect with a study center

  • Minnesota Clinical Study Center

    New Brighton, Minnesota 55112
    United States

    Active - Recruiting

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