A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Palvella Therapeutics, Inc. · NCT05643872
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 16+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 45
- US sites recruiting
- 1
- Study start
- November 15, 2022
- Record last updated
- December 9, 2022
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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".
Being studied: PTX-022
Conditions: Pachyonychia Congenita
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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 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
Recruiting US locations
Minnesota Clinical Study Center
New Brighton, MN 55112
Site contact: Study Coordinator · 763-502-2929
Study contacts (from the official record)
- Emily Cook · 267-738-6366 · emily.cook@palvellatx.com