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

Study acronym: SELVA
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 40 to confirmed 51
    • Primary completion date changed from estimate of Jan 2026 to Jan 14, 2026
    • Site details revised at 15 of 15 sites
    v8
  2. Eligibility criteria revisedv7
  3. Study sites: 13 to 15v6
  4. Study sites: 10 to 13
    • Start date changed from estimate of Jul 2024 to Jul 31, 2024
    • Collaborators expanded, about 6 words
    v5
  5. Secondary endpoints: details revised at 5 of 6 entries
    • Study title shortened, about 2 words
    v4
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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 9 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 50 to 40
    • Study sites: 11 to 10
    • Primary completion date: Dec 2025 to Jan 2026
    • Study completion date: Jan 2026 to Jul 2026
    • Interventions: Placebo (Drug), QTORIN 3.9% Rapamycin Anhydrous Gel (Drug) to QTORIN 3.9% Rapamycin Anhydrous Gel (Drug)
    • Secondary endpoints: 5 to 6
    • Study arms: 2 to 1
    • Study title shortened, about 4 words
  2. Start date: Apr 2024 to Jul 2024
    • Study sites: 10 to 11
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06239480
Lead Sponsor Palvella Therapeutics, Inc.
Collaborators: FDA Office of Orphan Products Development
Conditions
(from sponsor)		 Microcystic Lymphatic Malformation
Related terms Congenital Abnormalities, Lymphangioma, Lymphatic Abnormalities, Vascular Malformations
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov