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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Pachyonychia Congenita

In brief

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.

Key facts

Study ID

NCT03920228

Run by

Palvella Therapeutics, Inc.

People needed

73

Starts

2019-04-01

Expected to finish

2020-10-19

Last updated by the study team

2024-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients, 18 years or older
• Diagnosed Pachyonychia Congenita (PC), genetically confirmed
• Moderate to Severe PC
• Able and willing to comply with all protocol-required activities
• Willing and able to provide written informed consent

You may not qualify if…

• Any significant concurrent condition (including involving the inferior to the ankle) that could adversely affect participation.
• Any intentional changes in the patient's daily activities (associated with standing, walking and keeping balance), not resulting from an improvement in the patient's condition due to treatment.
• Patient's deemed by the investigator as unwilling or unable to remain compliant with all tests and procedures, including adherence to study drug administration and other protocol-required activities.

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• Stanford University — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• International Dermatology Research — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Paddington Testing Co. — Philadelphia, Pennsylvania, United States
• University of Utah — Murray, Utah, United States

Full record on ClinicalTrials.gov

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