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

Palvella Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Microcystic Lymphatic Malformation

Treatments: Drug: QTORIN 3.9% Rapamycin Anhydrous Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT06239480

PALV-09

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participant must be at least 6 years of age at time of consent
• Participant must have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation

Key Exclusion Criteria:

• Participants who have vascular malformations that interfere with evaluating the target microcystic lymphatic malformation
• Participants with complicated vascular anomalies with severe systemic symptoms that require systemic therapy
• The participant's treatment area is mainly in any wet mucosa or within the orbital rim
• Participants who are pregnant or planning to become pregnant

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Active

Experimental group

Treatment:

Drug: QTORIN 3.9% Rapamycin Anhydrous Gel