A phase 3, randomized, parallel, multicenter, double-blind, placebo-controlled study to investigate efficacy and safety of KP-001 in patients aged ≥2 years with common venousmalformations, common lymphatic malformations, or KTS/CLOVES syndrome

Date Added
May 5th, 2026
PRO Number
Pro00149432
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this study is to measure the efficacy and safety of KP-001 compared to placebo in patients with common venous malformations (VM), common lymphatic malformations (LM), or KTS/CLOVES syndrome. This phase 3, double-blind, randomized, placebo-controlled, parallel-group study will take place at multiple sites across North America. Vascular malformations like VM, LM, and KTS/CLOVES syndrome are serious, rare diseases with significant unmet medical needs. The study includes a 24-week double-blind treatment period with either KP-001 or placebo, followed by an open-label phase where all patients receive KP-001 up to Week 52. Patients weighing 40 kg or more will receive 100 mg of KP-001 once daily after breakfast, while those weighing less than 40 kg will receive a reduced dose based on their body weight.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
843-792-4091
mcleodke@musc.edu



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