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NCT05643872 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
A Phase 3 study of Pachyonychia Congenita, sponsored by Palvella Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT05643872: Recruiting Phase 3 study of Pachyonychia Congenita, sponsored by Palvella Therapeutics.
NCT05643872 is a Phase 3 study of Pachyonychia Congenita that is actively recruiting participants, run by Palvella Therapeutics. The registered enrollment target is 45 participants, below the 531-participant average among 4 other Pachyonychia Congenita trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05643872, a Phase 3 study of Pachyonychia Congenita, is actively recruiting participants, sponsored by Palvella Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
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".
Conditions Studied
Interventions
- DRUG PTX-022
Study Locations (1)
Minnesota
- Minnesota Clinical Study Center - New Brighton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-11-15 |
| Est. Completion | 2023-11 |
| Phase | Phase 3 |
What NCT05643872 shows while recruiting
NCT05643872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 531-participant average among 4 other Pachyonychia Congenita trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Pachyonychia Congenita appearing as the primary indexed condition, and to 1 intervention - of which PTX-022 is the first listed.
NCT05643872 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05643872 about?
NCT05643872 is a clinical study titled "A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita". 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 t...
What is the current status of trial NCT05643872?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 2022-11-15. Estimated completion is 2023-11.
What conditions does trial NCT05643872 study?
This clinical trial studies the following conditions: Pachyonychia Congenita.
What interventions are being tested in trial NCT05643872?
The interventions under investigation include: PTX-022 (DRUG).
Who is sponsoring clinical trial NCT05643872?
This trial is sponsored by Palvella Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05643872 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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