A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Purpose
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".
Condition
- Pachyonychia Congenita
Eligibility
- Eligible Ages
- Over 16 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Completed the PALV-05 (VAPAUS) study - Agree to contraceptive use
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PTX-022 |
|
Recruiting Locations
Minnesota Clinical Study Center
New Brighton, Minnesota 55112
New Brighton, Minnesota 55112
Contact:
Study Coordinator
763-502-2929
Study Coordinator
763-502-2929
More Details
- Status
- Recruiting
- Sponsor
- Palvella Therapeutics, Inc.