A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Recruiting
Phase 3
Interventional Study
Pachyonychia Congenita
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 45 (estimated)
- Sponsor
- Palvella Therapeutics, Inc. · Industry
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About This Trial
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".
Trial Locations
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Eligibility Criteria
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 …
Contacts