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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05643872
The ClinicalTrials.gov registry entry for NCT05643872 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 531-participant average among 4 other Pachyonychia Congenita trials with a reported enrollment target (92% lower). The listed sponsor is Palvella Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
Learn More About Clinical Trials
Similar trials for Pachyonychia Congenita
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita
COMPLETED · Phase 3
-
International Pachyonychia Congenita Research Registry
RECRUITING
-
Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)
COMPLETED · Phase 1
-
Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in Treatment of Adults With Pachyonychia Congenita
COMPLETED · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
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