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Clinical Trials in the USA / NCT05643872
Recruiting Phase 3

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

NCT05643872 · tracked via the Priya Life Science USA tracker
Sponsor
Palvella Therapeutics, Inc
Phase
Phase 3
Started
2022-11-15
Last updated
2022-12-09

Condition(s) studied

Pachyonychia Congenita

Investigational drug(s) / intervention(s)

PTX-022 →

PTX-022: QTORIN rapamycin 3.9% anhydrous gel

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

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Completed the PALV-05 (VAPAUS) study * Agree to contraceptive use Key Exclusion Criteria: * Females who are pregnant or breastfeeding * Concomitant use of sirolimus or any sirolimus-containing medications (systemic or topical) * Any significant concurrent condition that could adversely affect participation and/or the assessment of the safety and efficacy in the study * Prior or planned treatment, including surgery or other medically necessary intervention deemed by the investigator that could adversely affect participation and/or the assessment of the safety and efficacy in the study

Primary outcome measure(s)

  • Treatment emergent adverse events — 6 months

Trial sites (1)

FacilityCityRegionStatus
Minnesota Clinical Study Center New Brighton Minnesota Recruiting

More Palvella Therapeutics, Inc. trials in the USA

A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations Active, not recruiting
SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations Active, not recruiting
A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Angiokeratomas (LOTU) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05643872 on ClinicalTrials.gov ↗ ← All trials in the USA