SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations

Last updated: March 26, 2025
Sponsor: Palvella Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Holoprosencephaly

Birth Defects

Treatment

QTORIN 3.9% Rapamycin Anhydrous Gel

Placebo

Clinical Study ID

NCT06239480
PALV-09
  • Ages > 6
  • All Genders

Study Summary

SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations

The main purpose of this study is to assess the change in microcystic lymphatic malformations IGA after 24 weeks of treatment with QTORIN 3.9% Rapamycin Anhydrous Gel in approximately 40 participants with microcystic lymphatic malformations. Efficacy will be evaluated at 24 weeks and patients have the option of continuing on treatment for >24 weeks.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participant must be at least 6 years of age at time of consent

  • Participant must have a clinically confirmed superficial/cutaneous microcysticlymphatic malformation

Exclusion

Key Exclusion Criteria:

  • Participants who have vascular malformations that interfere with evaluating thetarget microcystic lymphatic malformation

  • Participants with complicated vascular anomalies with severe systemic symptoms thatrequire systemic therapy

  • The participant's treatment area is mainly in any wet mucosa or within the orbitalrim

  • Participants who are pregnant or planning to become pregnant

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: QTORIN 3.9% Rapamycin Anhydrous Gel
Phase: 3
Study Start date:
July 31, 2024
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Children's Hospital of Orange County

    Irvine, California 92612
    United States

    Active - Recruiting

  • Stanford University

    Palo Alto, California 94305
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City, Iowa 52245
    United States

    Site Not Available

  • Minnesota Clinical Study Center

    New Brighton, Minnesota 55112
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Vascular Birthmark Institute

    New York, New York 10016
    United States

    Active - Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina 27516
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Children's Hospital of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Vanderbilt Children's Hospital

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • University of Texas, Dell Children's

    Austin, Texas 78723
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah Health

    Salt Lake City, Utah 84113
    United States

    Active - Recruiting

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