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mTOR Inhibitor

Active for Pachyonychia Congenita (VAPAUS Trial)

Phase 3

Recruiting

Led By Joyce Teng, MD

Research Sponsored by Palvella Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

VAPAUS Trial Summary

This trial looks at whether QTORIN 3.9% rapamycin gel is safe and effective in treating adults with Pachyonychia Congenita.

Eligible Conditions

Pachyonychia Congenita

VAPAUS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient Global Assessment of Activities Difficulty Scale

Secondary outcome measures

Clinician global impression of change (CGI-C)

Clinician global impression of severity (CGI-S)

PROMIS physical function

+3 more

VAPAUS Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ActiveActive Control1 Intervention

Group II: VehiclePlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Palvella Therapeutics, Inc.Lead Sponsor

6 Previous Clinical Trials

279 Total Patients Enrolled

3 Trials studying Pachyonychia Congenita

154 Patients Enrolled for Pachyonychia Congenita

Amy Paller, MDStudy ChairNorthwestern University

17 Previous Clinical Trials

2,602 Total Patients Enrolled

Joyce Teng, MDPrincipal InvestigatorStanford University

2 Previous Clinical Trials

133 Total Patients Enrolled

1 Trials studying Pachyonychia Congenita

73 Patients Enrolled for Pachyonychia Congenita

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions is Active commonly used to help alleviate?

"Active is most frequently prescribed to patients who have undergone a transplant or those with liver disease. However, it can also be taken to treat kidney disease and renal angiomyolipomas."

Answered by AI

How many people total are allowed to participate in this clinical trial?

"Yes, that is correct. The trial was posted on 29th November 2021 and updated for the last time on 26th August 2022. The aim of the study is to enrol 80 patients at 7 sites."

Answered by AI

Are there any more slots open for volunteers of this research project?

"The trial is ongoing and presently looking for participants, according to the data available on clinicaltrials.gov. The study was first posted on 11/29/2021 and has had 8/26/2022 as its most recent edit date."

Answered by AI

Are there long-term consequences to using Active?

"Active has been given a safety score of 3. This is based on it being a Phase 3 trial, meaning that there is some data to support efficacy as well as multiple rounds of data supporting safety."

Answered by AI

Is this research being conducted at multiple locations within the state?

"There are 7 sites actively recruiting for this study, including Yale University in New Haven, Oregon Health and Sciences University in Portland, DermResearch, Inc. in Austin, among others."

Answered by AI

Does Active have a history of being studied in other trials?

"There are currently 130 clinical trials underway that involve Active. Out of those, 13 are in Phase 3. The majority of these trials originating from a single location in Cincinnati, Ohio; however, there are 1084 total locations running trials for Active."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Multicenter, Phase 3 Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Pachyonychia Congenita

2021. "A Multicenter, Phase 3 Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Pachyonychia Congenita". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05180708.

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