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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05643872
Other study ID # PALV-08
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 15, 2022
Est. completion date November 2023

Study information

Verified date December 2022
Source Palvella Therapeutics, Inc.
Contact Emily Cook
Phone 267-738-6366
Email emily.cook@palvellatx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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".


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date November 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Key Inclusion Criteria: - Completed the PALV-05 (VAPAUS) study - Agree to contraceptive use Key Exclusion Criteria: - Females who are pregnant or breastfeeding - Concomitant use of sirolimus or any sirolimus-containing medications (systemic or topical) - Any significant concurrent condition that could adversely affect participation and/or the assessment of the safety and efficacy in the study - Prior or planned treatment, including surgery or other medically necessary intervention deemed by the investigator that could adversely affect participation and/or the assessment of the safety and efficacy in the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PTX-022
QTORIN rapamycin 3.9% anhydrous gel

Locations

Country Name City State
United States Minnesota Clinical Study Center New Brighton Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Palvella Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment emergent adverse events 6 months
Secondary Pharmacokinetic parameters AUC area under the sirolimus blood concentration-time profile Prior to dose, 12 hours and 24 hours
See also
  Status Clinical Trial Phase
Completed NCT02592954 - Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin Phase 1
Active, not recruiting NCT04520750 - VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita Phase 3
Recruiting NCT05180708 - 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 Phase 3
Recruiting NCT05956314 - Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC Phase 1
Not yet recruiting NCT01382511 - Simvastatin Treatment of Pachyonychia Congenita N/A
Recruiting NCT05435638 - Study Designed to Evaluate Safety and Efficacy of 1% Topical Formulation of KM-001 on Type 1 Punctate Palmoplantar Keratoderma or Pachyonychia Congenita Diseases Phase 1
Completed NCT02152007 - Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC) Phase 1
Completed NCT00716014 - Study of TD101, a Small Interfering RNA (siRNA) Designed for Treatment of Pachyonychia Congenita Phase 1
Recruiting NCT02321423 - International Pachyonychia Congenita Research Registry
Active, not recruiting NCT03920228 - Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in Treatment of Adults With Pachyonychia Congenita Phase 2/Phase 3