The trial is taking place at:
D

DermResearch, Inc. | Austin, TX

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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 (VAPAUS)

P

Palvella Therapeutics

Status and phase

Enrolling
Phase 3

Conditions

Pachyonychia Congenita

Treatments

Drug: Vehicle
Drug: QTORIN 3.9% rapamycin anhydrous gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT05180708
PALV-05

Details and patient eligibility

About

This study evaluates the safety and efficacy of QTORIN 3.9% rapamycin anhydrous gel in the treatment of adults with Pachyonychia Congenita. This study includes a screening period, baseline period and 6-month treatment period.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Adult patients, 18 years or older (16 years or older in the UK)
  • Diagnosed with Pachyonychia Congenita (PC), genetically confirmed

Key Exclusion Criteria:

  • Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications.
  • Any significant concurrent condition (including conditions involving or inferior to the ankle) that could adversely affect the patient's participation and/or the assessment of the safety and efficacy in the study.
  • Participation in any other interventional clinical research trial within 30 days prior to the screening visit or during the patient's participation in this study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups, including a placebo group

Active
Active Comparator group
Treatment:
Drug: QTORIN 3.9% rapamycin anhydrous gel
Vehicle
Placebo Comparator group
Treatment:
Drug: Vehicle

Trial contacts and locations

8

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Central trial contact

Emily Cook

Data sourced from clinicaltrials.gov

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