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NCT03920228 · ClinicalTrials.gov registry record · Phase 2

Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in Treatment of Adults With Pachyonychia Congenita

A Phase 2 study of Pachyonychia Congenita, sponsored by Palvella Therapeutics.

Completed
Registry status
Phase 2
Development phase
73
Enrollment target
9
Study locations

NCT03920228: Completed Phase 2 study of Pachyonychia Congenita, sponsored by Palvella Therapeutics.

NCT03920228 is a Phase 2 study of Pachyonychia Congenita that has completed, run by Palvella Therapeutics. The registered enrollment target is 73 participants, below the 524-participant average among 4 other Pachyonychia Congenita trials with a reported enrollment target (86% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03920228, a Phase 2 study of Pachyonychia Congenita, has completed, sponsored by Palvella Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
73 participants
Enrollment target
9
Study locations

Study Summary

This study evaluates the safety and efficacy of PTX-022, topical rapamycin, in the treatment of adults with moderate to severe Pachyonychia Congenita. This study includes four-parts, and if a participant completes all parts, the participant will have received at least 3-months of PTX-022 treatment.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG PTX-022

Study Locations (9)

Arizona

  • Arizona Research Center - Phoenix

California

  • Stanford University - Palo Alto

Connecticut

  • Yale University - New Haven

Florida

  • International Dermatology Research - Miami

Illinois

  • Northwestern University - Chicago

Minnesota

  • Minnesota Clinical Study Center - Fridley

Oregon

  • Oregon Health and Science University - Portland

Pennsylvania

  • Paddington Testing Co. - Philadelphia

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2019-04-01
Est. Completion 2020-10-19
Phase Phase 2
Palvella Therapeutics

9 total trials

What the finished NCT03920228 record still lists

NCT03920228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 524-participant average among 4 other Pachyonychia Congenita trials with a reported enrollment target (86% lower).

The record links to 1 condition, with Pachyonychia Congenita appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03920228 lists 9 locations in 9 states (Arizona, California, Connecticut).

Frequently Asked Questions

What is clinical trial NCT03920228 about?

NCT03920228 is a clinical study titled "Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in Treatment of Adults With Pachyonychia Congenita". This study evaluates the safety and efficacy of PTX-022, topical rapamycin, in the treatment of adults with moderate to severe Pachyonychia Congenita. This study includes four-parts, and if a participant completes all parts, the participant will have received at least 3-months of PTX-022 treatment.

What is the current status of trial NCT03920228?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2019-04-01. Estimated completion is 2020-10-19.

What conditions does trial NCT03920228 study?

This clinical trial studies the following conditions: Pachyonychia Congenita.

What interventions are being tested in trial NCT03920228?

The interventions under investigation include: Placebo (DRUG), PTX-022 (DRUG).

Who is sponsoring clinical trial NCT03920228?

This trial is sponsored by Palvella Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03920228 being conducted?

This trial has 9 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT03920228, the US trial registry maintained by the National Library of Medicine. NCT03920228 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.